Do social and economic disparities, within the same country, determine different prematurity risk levels? In other words, are pregnant women with lower income or living in a socially and economically disadvantaged environment more likely to give birth to a preterm baby?
Several studies show that the answer is yes!
Let’s consider the USA, for instance. The first data to be pointed out is that more than 10 percent of babies born in the USA are preterm, which is a quite high rate for an industrialized and developed country. This rate has been steadily growing in the last years, and in 2020, for the first time in six years, it declined slightly from 10.2% to 10.1% (2021 March of Dimes Report Card). Amongst the potential reasons identified for this high rate we can mention a general lack of prenatal care, obesity, tobacco use and fertility treatments, which can all lead to early births.
What is really astonishing is the large inequalities striking women based on their socio-economic status, and also on their ethnicity. Preterm birth rate among black women is 51% higher than the rate among all other women. Black women have on average 14% preterm birth rates, compared to 9.2% of white women. American Indians and Alaska natives have the second highest rate (11.7%), followed by Hispanic women (9.8%). The same disparity exists for what concerns preterm deaths. While the overall US infant mortality rate is 5.6 every 1,000 live births, for black women this rate reaches 10.9 per 1,000 births, almost doubling the average, compared to the 4.7 rate in white women, and 5.2 for Hispanic, while American Indians and Alaska natives stand at 8.6.
The causes must be searched in socio-economic factors which are also determinants of health, and are heavily impacted by racial and ethnic disparities. Amongst such determinants, the income level as well as the poverty rate of the area where the mothers live have been both associated to prematurity risk.
Income inequality is a factor of major concern, since the economic divide in the USA is the largest since 1928. A 2016 study [Wallace] examined the risk of preterm birth in the context of increasing income inequality. By collecting data related to 12 States in the USA with almost 230,000 live births over 6 years, the study showed that any increase in state-level income inequality from the year prior to birth was associated with an independent 7% increased risk of preterm delivery. Women who were pregnant in an area where inequality was increasing were more likely to give birth preterm.
Another study [De Franco] investigated the independent effect of county-level poverty on preterm birth risk. By analysing almost 635,000 live births in 155 counties in Missouri, the study concluded that women living in counties with the highest poverty rate were 1.30 times more likely to deliver preterm infants.
Socio-economic factors, low income, racial and ethnic inequalities can also be considered for explaining the significantly different preterm rates between developed countries. For instance, in the USA, South-Eastern States have higher rates, reaching even 14.2% in Mississippi, 12.9% in Alabama and Louisiana, 11.8% in Arkansas, compared to 8.6% in Washington, 8.8% in California, and 9.2% in New York (US average at 10.1%). In Europe, prevalence rates of preterm birth range from 5.4 to 12.0%, from less than 6% in Finland, Latvia, Estonia, Sweden, and Lithuania, to more than 8% in Belgium, Germany, Hungary, Greece (European average at 7.3%).
Therefore, even in countries with comparable levels of development and healthcare systems, preterm birth rates vary significantly, and several reasons have been explored. For instance, a 2015 study [Delnord] on the disparities in the preterm birth rate in European countries indicated modifiable population factors – BMI, smoking, and environmental exposures – as well as medical practices and policies related to infertility treatments as impacting factors on country-level preterm birth rates.
A lot of knowledge gaps exist around prematurity, and still the causes of preterm birth remain unidentified in up to half of all the cases. But evidence collected on the effect of socio-economic and racial inequalities on preterm birth rates and preterm deaths between countries and within the very same country should more and more direct governments’ intervention strategies to fight prematurity. Such strategies clearly need to include actions to ameliorate conditions of poverty and reduce income disparity, and also to reinforce antenatal and postnatal care in low-income countries and in the most disadvantaged areas of developed countries.
The WHO stated that more than three-quarters of preterm infants could be saved with feasible, cost-effective care, and further reductions are possible through intensive neonatal care. The mission of our Preemie system is to contribute to this fundamental goal, by making it possible to ensure personalized nutrition to each preterm infant, wherever in the world.
DeFranco, Emily A, et al., Area-level poverty and preterm birth risk: A population-based multilevel analysis, BMC Public Health 2008, 8:316 doi:10.1186/1471-2458-8-316.
Delnord, Marie et al., What contributes to disparities in the preterm birth rate in European countries?, Curr Opin Obstet Gynecol 2015, 27:133–142 doi:10.1097/GCO.0000000000000156
Wallace, Maeve E., et al., Preterm Birth in the Context of Increasing Income Inequality, Matern Child Health J. 2016 January ; 20(1): 164–171. doi:10.1007/s10995-015-1816-9.
WHO, Born Too Soon, The Global Action Report on Preterm Birth, 2012.
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The power of data analysis is revolutionising all industrial sectors and the way in which many professionals work and take decisions. Healthcare makes no exception, and this is particularly true when risk prediction of developing specific conditions and diseases, as well as their management, come into play.
In neonatology, we know that several diseases are considered multi-factorial conditions, for instance Bronchopulmonary Dysplasia (BPD), meaning that many different variables contribute to their occurrence and severity. Collecting data about all such factors and monitor their changes over time can provide neonatologists with accurate risk prediction of the occurrence of the disease, and prompt preventive actions to avoid it occurs or minimise its severity.
More interestingly, data to be collected are linked to factors which do not strictly belong to the clinical sector, but can span over different categories, including demographic and socio-economic factors. A notable example is constituted by the so-called “social determinants of health” (SDoH), that is non-medical factors that influence people’s health, causing an impact in their medical outcomes, as defined by the World Health Organisation . They include factors such income and social condition, education, social connections, security levels, specific habits towards health and wellbeing, such as the use of tobacco, alcohol or drugs, dietary habits and physical activity, as well as the psychological status and vulnerabilities. As we would aspect, several studies demonstrated that such factors are associated with adverse maternal effects, and above all with preterm and low birth weight births. SDoH have been identified as risk factors for preterm birth, such as low maternal socio-economic status , maternal medication abuse and mental stress , and high psychosocial vulnerability .
But how can such factors be tracked down and prompt interventions for reducing the health risks for the mothers and their children?
The first step is to develop a system for effective identification of the SDoH that expose mothers at higher risks for their pregnancy and for the infants. An example is the Social Vulnerability Index (SVI) developed by the Centers for Disease Control and Prevention (CDC) in the USA . The index has been created to identify “at risk” communities based on the analysis of 15 different community features grouped in 4 main themes: socioeconomic status (theme 1), household composition and disability (theme 2), minority status and language (theme 3), housing type and transportation (theme 4).
Even if the SVI had been created for community interventions, a 2021 retrospective cohort study has demonstrated that the SVI is a valuable tool to identify pregnant women at high risk of preterm birth, and therefore can be used by clinicians to collect information regarding the local home environment of their patients and further refine preterm birth risk assessment . The study demonstrated that mothers delivering preterm birth were more likely to live in an area with a higher overall SVI and higher vulnerability in each of the 4 themes, and that the highest SVI scores were noted among those delivering at the earliest gestational ages.
A recent study showed how the SVI can be successfully integrated into the clinical practice . At first admission to the hospital, pregnant women are required to fill in the SDoH questionnaire, which includes questions related to the main themes to calculate the SVI, including financial strains, food insecurity, transport needs, physical activity, stress, social connections, housing stability, depression, use of tobacco and alcohol. As illustrated in Figure 1, the questionnaire not only generates an overall SDoH score, but generates a visual assessment of each the themes, thus providing doctors with alerts on each social determinant and detecting potential cases that need medical attention.
Figure 1. Screenshot of SDoH tool built-in in the electronic health records system in the hospital at the Louisiana State University Health Sciences Center (USA). Source: Ariana Bolumen, Electronic Alerts on the Social Determinants of Health, Neonatal Intensive Care, Vol. 35 No. 1, Winter 2022.
But how can doctors support “higher risk” women and mitigate the impact of social determinants on the health outcomes of mothers and of their infants?
Another recent study aims to provide an effective answer . The study intends to determine the effectiveness of preventive interventions to reduce preterm birth among pregnant women with psychosocial vulnerability factors, through a systematic review of preventive interventions. As a result of the analysis, massages provided by partners and group meetings showed to have a significant preventive effect on preterm birth, while other interventions such as home visits and phone calls had no significant preventive effect. Furthermore, the use of financial income supplement showed a reduction in preterm births. Besides the effectiveness of single interventions, which is questioned since the studies reviewed have moderate or high risk of bias, two conclusions seem to be particularly important.
The first is that pregnant women with different vulnerabilities are often offered the same intervention, although research shows that interventions should be tailored to each woman’s needs and circumstances. This shows that also the social determinants of health need a person-centric, tailored approach in order to minimise their adverse impact on pregnant women and on their infants.
The second is that the level of evidence for such kind of interventions is still very limited, and lacks quality research with robust designs and sample sizes providing recommendation of specific programmes to reduce preterm birth among vulnerable pregnant women. In this case, we firmly believe that the power of data analysis and the use of innovative techniques such as Artificial Intelligence and Machine Learning can provide unique insights into the weight that each risk factor has on preterm birth, as well as into the most effective interventions tailored for the unique vulnerabilities that pregnant women experience.
Innovative approaches based on AI-backed data analysis can boost game-changing approaches, facilitate the evaluation of the effectiveness of personalised approaches, and guide policies and clinical practice to take in consideration socio-economic determinants of health and effectively prevent their impact on health outcomes.
 Amjad S, MacDonald I, Chambers T, et al. Social determinants of health and adverse maternal and birth outcomes in adolescent pregnancies: A systematic review and meta- analysis. Paediatr Perinat Epidemiol. 2019;33(1):88-99. doi:10.1111/ppe.12529
 Moradi G, Zokaeii M, Goodarzi E, Khazaei Z. Maternal risk factors for low birth weight infants: A nested case-control study of rural areas in Kurdistan (western of Iran). J Prev Med Hyg. 2021;62(2):E399-E406. Published 2021 Jul 30. doi:10.15167/2421-4248/jpmh2021.62.2.1635
 Pedersen JF, Kallesøe SB, Langergaard S, Overgaard C. Interventions to reduce preterm birth in pregnant women with psychosocial vulnerability factors-A systematic review. Midwifery. 2021;100:103018. doi:10.1016/j. midw.2021.103018
 Givens M, Teal EN, Patel V, Manuck TA. Preterm birth among pregnant women living in areas with high social vulnerability. Am J Obstet Gynecol MFM. 2021;3(5):100414. doi:10.1016/j.ajogmf.2021.100414
 Ariana Bolumen, Electronic Alerts on the Social Determinants of Health, Neonatal Intensive Care, Vol. 35 No. 1, Winter 2022.
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January 20th, 2022 – London, England: New article on cost-benefit analysis of Targeted Fortification by Preemie System is published in Neonatal Intensive Care Journal
The team of Preemie System is happy to announce that a recent article on the cost-effectiveness of the Targeted Fortification Approach for very low birth weight infants (VLBF) has been accepted and published in the Neonatal Intensive Care Journal, Volume 35, No. 1 Winter 2022.
The article was researched and written by Paolo Satta, Isabel Hoffmann, and Diogo Barros, and is a comprehensive study on the cost-benefit analysis of Targeted Fortification. It quantifies the total costs versus the economic benefits of Targeted Fortification over Standard Fortification.
Human milk is the ideal nutrition recommended for all very low birth weight infants. However, human milk is highly variable in nutrient content and does not address the nutritional needs of this group of infants. Fortification of human milk is recommended in order to prevent extrauterine growth retardation and associated poor neurodevelopmental outcomes. Standard Fortification, performed with fixed doses of a multicomponent fortifier, does not account for the variability in milk composition, but it is less costly than Targeted Fortification, where fortifiers are added to breast milk based on the results of breast milk analysis.
Based on the analysis of selected studies that pointed out the clinical outcomes obtained when adopting the Targeted Fortification approach, the article raises the awareness that Targeted Fortification, although more expensive to implement than Standard Fortification, has far superior clinical outcomes and can effectively prevent several very costly diseases associated with malnutrition, proving to be a much better cost-effective solution for feeding very low birth weight infants.
“We are very pleased to have our article published in the well-renowned Journal of Neonatal Intensive Care in the USA.” remarked Isabel Hoffmann, CEO of Tellspec LTD, the company that developed the Preemie System. “Because it shows that the Preemie System helps decrease the overall cost of care for very low birth weight infants, despite the added cost of Preemie Sensor, the associated software, and the extra time to perform Targeted Fortification.”
In order to access the article stated on page 56 of the Neonatal Intensive Care magazine (Vol. 35 No. 1 Winter 2022), please click here and/or request a copy of the article (hardcopy will be available on February the 1st, 2022).
ABOUT PREEMIE SYSTEMS The Preemie System is the first clinical AI platform to deliver optimal infant-centric feeding and care. It also offers an end-to-end solution to individualized, targeted fortification by analyzing the unique chemistry of human milk with the use of rapid, reliable, and cost-effective sensor, and dedicated AI-based software. Preemie’s software also tracks and reports information about infant growth and its correlation to the milk fortification given.
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On October 15th – 16th 2021, the Preemie system attended and supported the latest 2021 EMBA International Congress, which took place in Warsaw. The 2021 EMBA International Congress, one of the most prestigious events in the field, reunited the most reputable researchers in neonatology and infants’ nutrition from all over the world.
This year’s event was organized as a hybrid congress, which made it possible for the attendees to attend the event in person or using a dedicated digital platform.
The Preemie system was represented by our COO Paolo Satta, who presented the latest “Cost-Benefit Analysis comparing Targeted Fortification Versus Standard Fortification Approach for Very Low Birth Weight Infants”. The 15-minute presentation was aimed at answering a key question: “Is targeted fortification cost-beneficial?”.
By considering a 50-bed Neonatal Intensive Care Unit (NICU) performing human milk analyses every day as a reference scenario, the study started presenting the overall costs to be borne in order to adopt targeted fortification. The costs for using different human milk analyzers had been identified, encompassing the purchase of the analyzer and other equipment, costs for consumables, the increased labour costs for both performing human milk analysis and calculating the fortification needed, and also the costs for wasted milk. Expected cumulative costs after 10 years of usage range in between $565,000 and $1,060,000.
The following step was to present the potential benefits, by referencing to relevant literature for what concerns the expected health outcomes, that is the reduction in the prevalence of key disease: necrotising enterocolitis (NEC), bronchopulmonary dysplasia (BPD), and sepsis. By considering the percentage of reduction reported in various studies and the incremental costs associated with the occurrence of the identified diseases, the potential economic savings associated to disease reduction were presented. Annual savings can be huge, ranging from almost $650,000 just for NEC reduction, to almost $400,000 for sepsis reduction, and $500,000 for BPD reduction. If such health outcomes are confirmed by larger clinical trials (and possibly other outcomes are identified), the savings in just 1 year of targeted fortification would cover the costs for 10-year usage of the targeted fortification approach.
Figure 1. Savings expected just for NEC reduction entirely cover the costs for targeted fortification, and in less than 2 years pay back the expenses for 10-year adoption of the approach.
The presentation ended with a final question: in case that only one health outcome (for instance NEC reduction) is confirmed and not the others, what is the reduction rate needed to cover the costs of the targeted fortification approach? The results are surprisingly very low. Let’s take just the NEC use case: a net reduction in the order of 0.34-0.65% in NEC prevalence would cover the targeted fortification costs, corresponding to 11 to 21 NEC cases avoided in 10 years in the 50-bed NICU unit. Studies available to date report much higher net reduction rates, up to 4% for NEC.
Figure 2. A very reasonable reduction in each disease’s prevalence rate would cover the costs of the targeted fortification approach. Such reduction rate is quite lower than the one reported in literature.
This allowed the presentation to reach this conclusion: we certainly need more studies on targeted fortification, larger clinical trials with limited biases and large infants’ groups, but the result of this preliminary analysis is that “targeted fortification is very, very likely cost-beneficial”.
As a final call to action, the audience was invited to interact with Preemie to perform use-case studies based on actual data from the NICU. Preemie designed a Cost-Benefit Analysis Model which can be filled in with the actual data of the NICU (for instance, number of infants hospitalized, number of infants with diseases, costs for adopting a targeted fortification approach, actual reduction of diseases, etc.), predict the expected savings when adopting the targeted fortification approach, and then track data over time to confirm the extent of the savings. This CBA Model could become a reference tool for administrators to track expenses and savings linked to infants’ nutrition, and we are eager to collaborate with NICUs to streamline our approach.
Therefore, don’t miss the opportunity to collaborate with us and reach out by writing at email@example.com.
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Several studies have been executed so far to assess the benefits of the targeted fortification approach when compared to the standard approach currently adopted (see Fabrizio 2020 for a recent review). These studies allowed us to appreciate the potentiality of targeted fortification in improving the clinical outcomes for preterm infants.
While standard fortification poses the infants at risk of not getting the recommended intake, due to the lack of knowledge of the actual macronutrient content in the administered human milk, the targeted approach allows neonatologists to fortify the milk based on the actual milk content, which implies that the feeding given is tailored to the specific infants’ need.
Amongst the most promising results evidenced so far, infants fed with the targeted approach experience higher macronutrient intakes, higher weight gain and in general improved growth velocities for what concerns weight, length, and head circumference. They also show higher fat-free mass and less frequent feeding intolerance. Such results are due to a limited variation of macronutrient intake, which allows for a more balanced and constant diet. Infants get similar composition every day, avoiding the administration of lots of proteins or fat on one day, and less proteins or fat the other day, thus posing less stress on their premature gut and metabolism. Such outcomes have been recently linked to a reduced neonatal morbidity, in particular for what concerns the occurrence of NEC, sepsis and bronchopulmonary dysplasia (see Rochow 2020 and Sánchez Luna 2020). There is clearly the need to confirm those results, and above all quantify them, through specifically designed interventional trials. Meanwhile it’s not surprising that an increasing number of hospitals and neonatologists is implementing the targeted approach for managing the feeding of preterm infants.
But there is also the other side of the coin: compared to the standard approach, targeted fortification is more time-consuming, requires the purchase and maintenance of specific equipment for analysing human milk, and also trained staff for both operating the device and for calculating the fortification needed. Rochow 2015 estimated an average of 10-15 minutes per patient per day for applying this approach, which clearly raises the overall operational costs of the nursery.
In order to contain such costs and make the targeted approach sustainable in all nurseries, studies have been performed to assess the most cost-effective frequency of human milk analysis, trying to minimize as much as possible the macronutrient variation in infants’ feeding from day to day, but also reducing the workload for operators. For instance, Rochow 2015 suggested to perform human milk analysis “at least twice a week” as an optimal trade-off.
So, if we consider both benefits and costs, the big question is: is the targeted approach really cost-beneficial? To give an accurate answer, specific health economics studies are needed, where costs for implementation and maintenance of such an approach are compared to economic quantification of evidence-based benefits (for instance, savings generated by reducing the length of stay or key diseases, such as NEC).
Far from being an exhaustive article on this topic, we want here just to highlight a few available data aimed to provide a sense of the potential savings that could be generated by applying the targeted approach.
Reduction of length of stay. Several studies mentioned this potential benefit (see Rochow 2015), even if this has not been confirmed yet in the trials performed so far. The cost per hospitalization day varies from Country to Country, and even amongst hospitals in the same area. We take as a reference two studies performed by Johnson (2013 and 2015), where the average cost per hospitalization day of a VLBW infant was estimated respectively at $1,052 and $1,874. A hospital serving an average of 100 infants per year would therefore get significant savings even with just a 1-day reduction of the length of stay per infant (between $100,000 and $180,000).、
Reduction of parenteral nutrition. A more balanced diet in line with the targeted requirements may help in a faster switch from parenteral to enteral nutrition. Savings could be quite significant, if we consider that around $1,436 is spent daily per patient receiving parenteral feeding (Edwards 2012). In the use case of the previous point, savings per year could therefore reach around $143,000 in case of just 1-day reduction of parenteral feeding per infant.
Reduction of diseases during hospitalization. Since infants are fed with basically the same macronutrient composition over time, their gut works under more steady condition, and this is considered a factor for reducing the occurrence of specific diseases. This is going to be studied in upcoming clinical trials (see Seliga-Siwecka 2020), while other studies reported a reduction of specific diseases (see Sánchez Luna 2020). Let’s consider three diseases whose reduction has been mentioned in such studies: NEC, sepsis and bronchopulmonary dysplasia. The costs for those diseases have been reported in various studies. In Johnson 2015 reported an average total NICU hospitalization cost (in 2012 dollars) of $180,163 per infants with NEC and $134,494 for infants without NEC. NEC was associated with a marginal increase in costs of $43,818. Johnson 2013 reported that the presence of bronchopulmonary dysplasia was associated with a $31,565 increase in direct costs, and late-onset sepsis with a $10,055 increase. Any assumptions on the reduction rate would be completely arbitrary at this point, but imagine that just one case of each disease is avoided every year in a hospital. This will make savings up to more than $85,000 every year.
Long-term economic benefits. Savings in this area are clearly the most complex to be demonstrated and quantified, since they require the quantification of savings on clinical complications after hospitalization and on potentially life-long morbidities. One focus of the analysis could be related to the long-term benefits (and related savings) due to avoiding under- and over-nourishment caused by the standard approach. Another example is related to avoiding neurological impairment, due to optimal growth and to the reduction of infants’ morbidities during the hospitalization period. Let’s make a some reasonings related to the latter point.
A key point is related to the “quality” of the weight gained during the hospitalization period. Parat 2020 showed that “targeted fortification of milk can influence the quality of weight gain through promoting fat-free mass in infants”, and early gain in fat-free mass has been demonstrated to generate positive long-term effects, unlike fat mass. Ramel 2016 demonstrated the association of fat-free mass at discharge with improved neurodevelopment in VLBW preterm infant at 12 months, while Scheurer 2018 showed that high percentage of fat mass is associated with lower-working memory performance in pre-school age (4 years). Another study (Frondas-Chauty 2018) demonstrated that a deficit of fat-free mass at discharge is associated with neurological impairment at two years of age.
Neurodevelopment impairment has also been demonstrated to more likely occur in infants who had NEC or sepsis (diseases that the targeted approach could reduce) than in preterm infants without such morbidities (see Rees 2006 and Cai 2019). Conditions such as cerebral palsy, vision impairment or hearing impairment could be reduced thanks to the optimal growth promoted through targeted fortification, or indirectly by reducing the occurrence of diseases that make such impairment more likely in a later age. And their costs are not negligible. Honeycutt 2015 showed that lifetime costs per person for cerebral palsy are around $804,000 (in US$ 2000), for hearing loss at $325,000 and for vision impairment at $469,000. This gives us a sense of how large the life-long savings could be both for the society and for the patients.
So, a lot of work is still needed to precisely quantify the economic benefits of the targeted approach through evidence-based studies, but the more our knowledge advances in this field, the more targeted fortification seems to provide promising results.
We therefore want to conclude this blog by mentioning Sánchez Luna 2020. The study reports the benefits coming from the establishment of a personalized nutrition unit (PNU), based on a smart management of mother’s milk and the application of targeted fortification. This approach led to “a significant reduction of NEC in preterm infants of < 32 weeks of gestation, from 10.9% (12/110) to 2.4% (2/84), and late-onset sepsis from 14.7 cases/1,000 days of central lines to 9.5 cases/1,000 days of central lines, with a shorter use of central venous catheters for parenteral nutrition and a better growth during hospitalization”.
We are firmly convinced that similar studies and their promising results will multiply in the near-future, not only evidencing the unique clinical benefits that the targeted approach can guarantee to preterm babies, but also demonstrating that the approach is sustainable and economically beneficial in both the short and long term. The path seems really to be market out, and Preemie is proud to give its contribution to this radical change.
Fabrizio 2020 – Fabrizio V, Trzaski JM, Brownell EA, Esposito P, Lainwala S, Lussier MM, Hagadorn JI. Individualized versus standard diet fortification for growth and development in preterm infants receiving human milk. Cochrane Database of Systematic Reviews 2020, Issue 11. Art. No.: CD013465. DOI: 10.1002/14651858.CD013465.pub2.
Rochow 2020 – Niels Rochow, Gerhard Fusch, Anaam Ali, Akshdeep Bhatia, Hon Yiu So, Renata Iskander, Lorraine Chessell, Salhab el Helou, Christoph Fusch. Individualized target fortification of breast milk with protein, carbohydrates, and fat for preterm infants: A double-blind randomized controlled trial. Published by Elsevier Ltd. 2020, https://doi.org/10.1016/j.clnu.2020.04.031.
Sánchez Luna 2020 – Manuel Sánchez Luna, Sylvia Caballero Martin, Carmen Sánchez Gómez-de-Orgaz. Human milk bank and personalized nutrition in the NICU: a narrative review, European Journal of Pediatrics, 2020, https://doi.org/10.1007/s00431-020-03887-y
Rochow 2015 – Niels Rochow, Gerhard Fusch, Bianca Zapanta, Anaam Ali, Sandip Barui and Christoph Fusch. Target Fortification of Breast Milk: How Often Should Milk Analysis Be Done?, Nutrients 2015, 7, 2297-2310; doi:10.3390/nu7042297
Johnson 2013 – Tricia J. Johnson, Aloka L. Patel, Briana J. Jegier, Janet L. Engstrom, and Paula P. Meier. Cost of Morbidities in Very Low Birth Weight Infants. THE JOURNAL OF PEDIATRICS, Vol. 162, No. 2, 2012. DOI:https://doi.org/10.1016/j.jpeds.2012.07.013
Johnson 2015 – Tricia J. Johnson, Aloka L. Patel, Harold R. Bigger, Janet L. Engstrom, and Paula P. Meier. Cost Savings of Human Milk as a Strategy to Reduce the Incidence of Necrotizing Enterocolitis in Very Low Birth Weight Infants. Neonatology. 2015 ; 107(4): 271–276. doi:10.1159/000370058
Edwards 2012 – Taryn M. Edwards, Diane L. Spatz. Making the Case for Using Donor Human Milk in Vulnerable Infants. Adv Neonatal Care. 2012 Oct;12(5):273-8; quiz 279-80. doi: 10.1097/ANC.0b013e31825eb094.
Seliga-Siwecka 2020 – Joanna Seliga-Siwecka, Anna Chmielewska and Katarzyna Jasińska. Effect of targeted vs standard fortification of breast milk on growth and development of preterm infants (≤ 32 weeks): study protocol for a randomized controlled trial. Trials (2020) 21:946 https://doi.org/10.1186/s13063-020-04841-x
Parat 2020 – Sumesh Parat, Praneeta Raza, May Kamleh, Dennis Super and Sharon Groh-Wargo. Targeted Breast Milk Fortification for Very Low Birth Weight (VLBW) Infants: Nutritional Intake, Growth Outcome and Body Composition. Nutrients. 2020 Apr 21;12(4):1156. doi: 10.3390/nu12041156.
Ramel 2016 – Sara E. Ramel, Heather L. Gray, Ellen Christiansen, Christopher Boys, Michael K. Georgieff, and Ellen W. Demerath. Greater Early Gains in Fat-Free Mass, but Not Fat Mass, Are Associated with Improved Neurodevelopment at 1 Year Corrected Age for Prematurity in Very Low Birth Weight Preterm Infants. J Pediatr. 2016 Jun;173:108-15. doi: 10.1016/j.jpeds.2016.03.003. Epub 2016 Apr 4.
Scheurer 2018 – Johannah M. Scheurer, Lei Zhang, Erin Plummer, Solveig Hultgren, Ellen W. Demerath, Sara E. Ramel. Body Composition Changes from Infancy to 4 Years and Associations with Early Childhood Cognition in Preterm and Full-Term Children. Neonatology 2018;114:169–176 DOI: 10.1159/000487915
Frondas-Chauty 2018 – Anne Frondas-Chauty, Laure Simon, Cyril Flamant, Matthieu Hanf, Dominique Darmaun, and Jean-Christophe Rozé. Deficit of Fat Free Mass in Very Preterm Infants at Discharge is Associated with Neurological Impairment at Age 2 Years. J Pediatr. 2018 May;196:301-304. doi: 10.1016/j.jpeds.2017.12.017.
Rees 2006 – Clare M Rees, Agostino Pierro, Simon Eaton. Neurodevelopmental outcomes of neonates with medically and surgically treated necrotizing enterocolitis. Arch Dis Child Fetal Neonatal Ed 2007;92:F193–F198. doi: 10.1136/adc.2006.099929
Cai 2019 – Shirley Cai, Deanne K. Thompson, Peter J. Anderson, and Joseph Yuan-Mou Yang. Short- and Long-Term Neurodevelopmental Outcomes of Very Preterm Infants with Neonatal Sepsis: A Systematic Review and Meta-Analysis. Children (Basel). 2019 Dec; 6(12): 131. doi: 10.3390/children6120131
Honeycutt 2015 – Amanda A Honeycutt, Scott D Grosse, Laura J Dunlap, Diana E Schendel, Hong Chen, Edward Brann, Ghada al Homsi. “ECONOMIC COSTS OF MENTAL RETARDATION, CEREBRAL PALSY, HEARING LOSS, AND VISION IMPAIRMENT” In Using Survey Data to Study Disability: Results from the National Health Survey on Disability. Published online: 10 Mar 2015; 207-228.
Whoever had the chance to access and move around in a Neonatal Intensive Care Unit knows how precious and extremely difficult the work of neonatologists and nurses is. Those tiny little babies are there, suffering, crying, their lives hanging by a thread, and your heart constricts at their sight, making you feel powerless. But doctors out there are not, and they fight every day to give those babies the chance to survive, to defeat prematurity and other diseases, to grow fast and thrive.
In such an emergency situation, whatever can be made which facilitates and supports their work, is not simply just an improvement into their daily workflow, but can have a huge clinical impact; it means that they have more time to focus on the care of their infants and on clinical decisions.
Therefore, more than in any other healthcare application, whatever improvement in efficiency of the workflow, support in data collection, visualization and analysis, and in healthcare delivery, can turn into improving clinical outcomes and even saving lives.
Since the very start of designing the Preemie System, we interacted with several neonatologists, paediatric dietitians, and nurses, and analyzed with them how our solution could improve their work, leveraging the possibility of rapid human milk analysis as well as the power that digitalization can offer in easing data collection, processing and analysis.
We want to point out some examples of how a fully digital approach can add value in managing infant feeding, not only by saving time (and money, of course), but also supporting healthcare professionals in their clinical decision-making process.
High level of flexibility to meet specific requirements
When it comes to feeding preterm infants, a clinical decision has to be made taking into account several factors, including the clinical history of the infant, the growth rate over time, and the amount of feeding administered over time.
Many other factors play a role which are dependent on the peculiar approach to fortification that the NICU has put in place in its protocol. It’s not just the approach being based on either standard, adjusted or targeted fortification, but also boundary conditions such as the guidelines with reference ranges for the fluid and macronutrients intake, or the selection of specific fortifiers which are being used in the hospital.
In order to track in a granular way what is actually being administered to the infant, all this data has to be taken into account, and a flexible digital system can allow any kind of customization in this sense. Not only the doctor could select customized guidelines for specific subgroups of infants, as well as use different fortifiers with all reference data being stored automatically. Customization can also span over more subtle features, where research is always ongoing and there is still lack of official guidelines.
An example is the estimated level of absorption of the macronutrients administered through enteral nutrition. By means of customizable settings to define such levels, based on the latest research and on neonatologists’ experience, doctors can make the most out of data when prescribing and monitoring the feeding, without the need to make any calculation. The system can track automatically how much milk and fortifiers have been prescribed, the amount of macronutrients that are going to be delivered, how much out of them it is estimated that the infant will actually absorb, as well as the actual amount of milk that the infant got against the milk prescribed.
Provide data insights to support clinical decisions
The amount of data collected is of high value when doctors make feeding decisions. Despite the need for standard protocols for properly managing infants’ health, healthcare delivery is more and more going towards a personalized approach, which ensures more effective clinical outcomes. Feeding management makes no exception, and such personalization has to firmly rely on key indicators based on data collection and analysis. Digital tools have the power to provide doctors with such indicators at a glance, through meaningful and easy-to-read visualizations. They enable us to compare growth and feeding over the last days, how much nutrients have been actually administered to the infant against the prescription, which fortifiers are providing the best outcomes, and therefore support doctors to make more informed decisions based on the infant’s health status.
Here is where technological innovation can play a crucial role, allowing specialists to collect data which makes personalization truly possible. This is the case of the Preemie Sensor, which allows doctors to analyse human milk and take into account the actual macronutrients content when calculating the fortification and the overall nutrition to be administered.
This is a fundamental step towards personalized healthcare, since now it is possible to exert accurate control over what is being administered, without relying on assumptions and average values in milk content.
Automatization, whenever possible
This is mostly about saving time and costs, and at the same time preventing the potential occurrence of human errors. Digital tools shall replace paper-based or spreadsheet systems, which are time-consuming and prone to errors, and support professionals in both basic and more complex calculations.
As an example, based on the guidelines selected and the weight of the infant, the system can immediately indicate the suggested range of fluid and macronutrient intake, to be considered as reference values by the doctor. More importantly, based on the real values of the milk content and the fortifiers used, the system can easily calculate and display the amount of macronutrients provided to the infant, thus enabling the doctor to tweak the target values of each macronutrient, and provide in output the related amount of fortifiers to be added. The system is thus able to support the users in each operation during the entire workflow, streamlining the calculation and the prescription process, and moreover making it possible to perform each operation anytime and anywhere.
As an example, the milk can be analysed in the human milk bank, and data are automatically stored in the system. Few hours later, the doctor can use the very same values to calculate the fortification and make the prescription in the office, and the prescription is then available in real time to the nurse at the NICU for her to actually fortify the milk and administer the prescribed feeding.
Metadata for empowered support
Maybe we are going too far, but every innovation must be inspired by a long-term vision. We know that nothing can replace the competence, sensitivity and experience of medical doctors, and that every innovation in the healthcare sectors shall be thoroughly tested and validated through clinical trials and scientific debate.
But at the same time, we are firmly convinced that the collection and use of big data and the application of disrupting technologies such as Artificial Intelligence can really empower healthcare professionals and support them in clinical decision-making.
Just imagine if doctors could tap into a huge database of clinical records (anonymized, of course), and when taking a decision (be it the choice of a fortifier, the amount to be used, or the amount of milk to be prescribed) display in real-time clinical records of a cohort of infants with a clinical history similar to the patient (e.g. gestational age, growth history, comorbidities), and thus know which choices from other doctors led to the desired outcomes and which did not.
Maybe it’s planning too far ahead, but we believe that such approaches will really revolutionize both research activities and clinical practice in the forthcoming future.
This is a step-by-step process, which involves embracing digital transformation and continuously finding innovative solutions, and we sincerely hope that the Preemie System will contribute to this challenging journey.
https://www.preemiesensor.com/wp-content/uploads/2021/05/Blogpost-2021May.png435700Communication Departmenthttps://www.preemiesensor.com/wp-content/uploads/2022/03/logologologo.pngCommunication Department2021-05-13 18:29:172021-06-28 16:30:30Challenges and opportunities in managing infant feeding in NICUs
Digital transformation, especially in this period of global pandemics, has become a fundamental factor to improve processes, efficiency and productivity in all kinds of industrial sectors. Healthcare makes no exception, and can now leverage innovative technologies able to drastically impact the quality of services provided to patients, such as Artificial Intelligence (AI)-enabled medical devices, or the application of blockchain technology to electronic health records, just to mention a few.
The use of digital tools can also significantly improve the way healthcare providers work, streamline and simplify their workflow, and finally enable them to focus more on what is most important in their mission, their patients’ care.
Narrowing down to human milk and feeding management for hospitalized term and preterm infants, few challenges apply. We know the extraordinary work that both Neonatal Intensive Care Units (NICUs) and Human Milk Banks (HMBs) perform every day to save infants’ lives and ensure they get all the nutrition they need to thrive. Innovative tools can support them in their daily work, not only providing new ways to personalize patients’ care, but also to automate, and therefore simplify operations, save time and costs, and avoid potential errors.
Unfortunately, NICUs and HMBs in Europe have different levels of digitalization, ranging from highly automated software systems to a poorly integrated mix of different tools, including dedicated software programmes, generic spreadsheet software such as Microsoft Excel, and paper-based records. One of the main issues is that each NICU and HMB has a specific procedure for managing human milk, collecting and storing the milk in the freezers, testing the milk for bacterial load, calculating the fortification needed for the infants, and so on. Digitalizing such variability of processes and improving their effectiveness through dedicated software requires a certain level of customization. This explains why NICUs and HMBs often use software solutions designed or even developed internally, or still exploit paper-based approaches or Excel files to record operations and calculate milk fortification.
We firmly believe that process automation through a dedicated end-to-end software solution like Preemie’s can bring several advantages, by reducing at the bare minimum human operations that waste time and generate errors (e.g. feeding an infant with the wrong milk, errors in calculating the milk fortification for the infant), and at the same time speeding up processes, especially when handling and processing human milk.
After having interacted with a large number of both NICUs and HMBs in Europe, it is worth to outline just a few examples of how digitalization could generate value. They don’t mean to be exhaustive, of course, but just to provide a sense of how a dedicated software solution can impact at different levels. These examples are related to the way HMBs manage the milk from reception to delivery, manage the processes at the HMB and the related data generated.
Control over the expiration date of the milk
This seems a simple operation, but still HMB operators in some cases do it visually by checking the bottles in the freezers. An automated way to infer such information in the software could prevent HMBs from losing expired milk, but also help them in selecting which milk should be delivered first to avoid aging.
Store and know the position of the milk, easily retrieve the milk, select the milk to be delivered based on specific factors (age, donor, type of milk): all such operations can be streamlined through the applications of filters in the software to select the most suitable milk to be prepared and also to identify where the milk has been stored in the freezer and in the related compartments, thus saving time for the operator.
Keeping track of the milk history seems to be one of the most time-consuming operations at the HMB. Registering the milk and its source, managing and storing the different batches received over time and how they are processed (pooling, thawing, pasteurizing, etc.), recording and managing requests for milk coming from hospitals, keeping track of milk prepared and delivered: they are just a few operations that require time and efforts for being recorded and tracked over time. All of them can be managed digitally, through software solutions that enable fast data entry, and above all keep all data recorded and readily available in case the operator needs to access whatever information – for instance, the milk batches that need to be pooled, the list and features of milk requested by hospitals, and so on. This also enables operators to be more focused on the actual operations to be performed on the milk, with less distractions for administrative work that could lead to milk contamination or mistakes.
Matching milk type and recipient
Milk’s content varies depending on various factors that can be tracked, including the fact of being term or preterm milk, single donor’s milk or pooled milk. Each HMB and NICU manages differently the milk based on such features. For instance, some HMBs do not pool milk while others do, others try to administer only colostrum-like milk to very fragile infants, while others provide milk to hospitals mainly based on logistics issues. In some cases, operators write down manually information about the milk on the bottle or in paper registries, which makes very time-consuming for them to retrieve the milk which matches specific recipients. An automated solution could easily support them in milk selection or even suggest this match based on pre-set instructions.
This is a more sophisticated example of how digitalization and innovative technologies can drive a step change in how neonatologists work and personalize care. After having analysed the milk received from donors by using the Preemie sensor, our system can suggest which milk batches should be pooled in order to reach certain levels of macronutrients (for instance, high or low protein levels), so as to match the specific needs of an infant. Needless to say, every operator and neonatologist we spoke was enthusiastic about this.
Clearly, similar examples can be mentioned in relation to the activity in the NICU, and also in the way NICUs and HMBs interact. In a following blog article, we will analyse in more detail how a digitalized approach can help neonatologists and nurse in calculating milk fortification, as well as parenteral and enteral nutrition, and how a fully integrated system can facilitate interactions between NICUs and HBMs, streamlining operations, enhancing transparency and traceability, and finally improving patients care.
https://www.preemiesensor.com/wp-content/uploads/2021/04/Blogpost_20210401.jpg7681365Xue Fenghttps://www.preemiesensor.com/wp-content/uploads/2022/03/logologologo.pngXue Feng2021-04-01 20:37:072022-03-03 20:14:53The value of a fully digital approach in Human Milk Banks
When we were first approached to design a medical device that would analyse breast milk, we challenged ourselves to do something different. We wanted to create something extraordinary that went beyond complicated medical interfaces typically seen in healthcare. This is why we think the colour, size, texture and simplicity in design resonates not only with the IDA Jury but with professionals within the industry as well.
– Massimiliano Datti and Alessandro Spalletta, Preemie Industrial Design Team –
This year IDA received thousands of submissions from over 80 countries in 5 primary design categories: Architecture, Interior Design, Graphic Design, Product Design, and Fashion Design. The international Jury evaluated the entries and sought out designs beyond the ordinary, seeking those that reflected the revolutionary leading the way into the future.
“The IDA seeks out truly visionary designers showcasing creativity and innovation. As the world struggled with an unprecedented challenge in 2020, the IDA received a record number of outstanding entries which presented the Jury with an enormous task in selecting the winners,” commented Jill Grinda, VP Marketing and Business Development as stated in the IDA press release.
“When developing the Preemie sensor, we wanted to keep the functionality and configuration as user friendly as possible. Its simplistic design makes it easy to use for NICUs and Human Milk Banks professionals.” Remarked Isabel Correa, CEO and Founder of Tellspec LTD. “There is nothing else like it on the market; the Preemie system is the first complete platform for the management of preterm feeding. We are honoured by the recognition given to us by the IDA Jury.”
https://www.preemiesensor.com/wp-content/uploads/2021/02/iDESIGNAWARD-PR-IMAGE.png7681365Xue Fenghttps://www.preemiesensor.com/wp-content/uploads/2022/03/logologologo.pngXue Feng2021-02-02 16:06:332022-03-03 20:03:07Preemie Sensor Wins Gold and Silver Awards from the International Design Awards (IDA)
Links to websites that inform, inspire, support, advocate, educate and feed the soul.
There is a tremendous amount of information on the web. Trying to learn more about your preemie baby can be overwhelming, so we created this list so you don’t have to. We tried to include links to sites that we felt would benefit you and your preemie.
If you want to add to this list, please email us at firstname.lastname@example.org; after all, sharing is caring, and knowledge is power!
We focused on publications that provide a section within their website dedicated to preterm babies.
NICU Parent Network a community for families with preterm infants offering support through information, stories and tools.
Preemie World Bloga platform that helps bridge the gap between medical professionals and families during their NICU journey.
A shortlist of resources to support the mind, body and soul as you take care of your newborn preemie.
Motherly an online community that inspires and connects.
Today’s Parent provides you parenting, baby, pregnancy and family insights through real-life stories and expert advice.
Absolutely Mama designed for the modern mom who wishes to forge her own path, filled with great insights and advice on parenting, lifestyle and fashion.
Mother&Baby covers every aspect of being a mom from pregnancy to baby to toddler.
Mother Magazine is designed to provide stories, lifestyle and health information for the modern mom.
Very Well family is a catch-all site with content ranging from stories to activities to online tools covering all aspects from pregnancy to raising healthy kids of all ages and stages to the latest news.
Breastfeeding.supportprovides articles, news, research, and breastfeeding information. It also has a map to find certified lactation consultants in your area.
HUMAN MILK BANKS
Sometimes mothers cannot provide their own milk to their newborns, and the reasons vary from not producing enough milk to physically being unable to breastfeed due to illness. Human milk banks operate to help provide the milk required to help babies grow, especially vulnerable low birth weight infants. If you have breastmilk to spare, please #donate it to your local human milk bank.
The Human Milk Foundation (HMF) created to help families feed their babies with human milk by providing screened donor breastmilk to premature infants in Neonatal Intensive Care Units within the United Kingdom. They are a non-profit supporting our most vulnerable infants with research, stories and updated news. Each donation makes a difference.
Locate your human milk bank within your country. Please note that some milk banks are located within the hospital itself.
For additional information and resources on human milk, please visit PATH organisation, a global non-profit that improves public health.
ORGANISATIONS AND AGENCIES
These initiatives focus on helping communities worldwide by addressing the issues around preterm births, conducting research and providing guidelines that advocate for change. You can support these organisations through donations as well.
NEC SocietyThis non-profit goal is dedicated to “building a world without necrotizing enterocolitis (NEC) through research, advocacy, and education. The NEC Society brings together patient-families, clinicians, and other diverse stakeholders to better understand, prevent, and treat this devastating neonatal intestinal disease.” They also offer a NEC Support Group for families and facts and educational information around necrotizing enterocolitis and what you need to know.
The Global Alliance to Prevent Prematurity and Stillbirth(GAPPS) The organisation mandate is to lead “a collaborative, global effort to increase awareness and accelerate innovative research and interventions to improve maternal, newborn and child health outcomes around the world.” You can scope out the different projects they are working on and they also have a resource area for preterm and stillborn guilds for families and supporters.
Originally published in the European Journal of Pediatrics, November 27, 2020. “This narrative review presents salient data of our current knowledge and concerns regarding milk feeding of preterm infants in the NICU, with special emphasis on personalized donor milk as a result of establishing a Personalised Nutrition Unit (PNU).” Written by Manuel Sánchez Luna, Sylvia Caballero Martin and Carmen Sánchez Gómez-de-Orgaz.
Today approximately 15 million babies are born prematurely and is ‘the leading cause of mortality among children aged under five years, with a majority of deaths due to preterm birth occurring in the neonatal period.
Nutrition is Key
To fight this problem, appropriate nutrition is a critical element in improving preterm babies’ survival and outcomes. Sometimes, instead of the mother’s own milk (MOM), donor milk (DM) from a similar gestational and lactation stage is given. This milk, provided by human milk banks (HMB), is composed of pooled term milk at various lactation stages. In some instances, they are far from having the characteristics of the MOM. In these circumstances, personalised fortification using DM is the ideal approach to feed preterm infants.
Preterm Milk Composition
A contributing factor for growth failure in preterm infants is low protein intake. Studies have shown that the mother’s milk of premature infants has significantly more protein, nitrogen, and amino acids during the first weeks of lactation. This unique combination of nutrients of the preterm milk properties contributes to the premature infants’ rapid growth rates. Also unique to breastmilk are human milk oligosaccharides (HMOs), which are known to be a strong protection for necrotizing enterocolitis (NEC). It is essential to state that the breastmilk’s pasteurization does not affect HMO content and that no differences were found between unpasteurized and pasteurized human milk for any or severe NEC.
Currently, 20% of donated breastmilk comes from mothers of preterm infants. In Brazil, a leader of human milk banks, 44% of their donors are mothers of preterm infants, and if the mother’s milk nutritional requirements are not met, then donor milk is often given to babies. In both cases, MOM or DM, personalised fortification is performed inside NICUs. A significant reduction in NEC and late-onset sepsis was correlated with the usage of personalized fortification. Due to the personalized fortification, a shorter use of central venous catheters for parenteral nutrition, which is the administering of nutrition intravenously and better growth during hospitalization was also associated with this.
Mother’s own milk is the healthiest and most convenient way of providing the essential nutrients to newborns. If the mother cannot provide her breastmilk, donor milk is a good alternative. On the other side, and as the milk composition varies with gestational age and stage of lactation, personalised feeding using donor milk from mothers with preterm infants, combined with personalised targeted fortification, is the optimal approach.
https://www.preemiesensor.com/wp-content/uploads/2021/01/IMAGE-FOR-DR-LUNA-ARTICLE-1.png7681365Xue Fenghttps://www.preemiesensor.com/wp-content/uploads/2022/03/logologologo.pngXue Feng2021-01-12 18:49:292022-03-03 20:03:55An overview of the research article on ‘Human milk bank and personalized nutrition in the NICU: a narrative review’
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No.879228.