Early Childhood Neurodevelopmental, Economic and Nutritional Outcomes among Former Very Low Birth Weight Infants from the Reducing Disparity in Mother's Own Milk (ReDiMOM) Trial

项目摘要 尽管大多数极早产儿（VP; <32周妊娠）存活至新生儿重症监护室出院， 在新生儿重症监护室（NICU），他们仍然处于神经发育受损（ND），肥胖和 心脏代谢疾病，加重家庭负担，并在整个生命周期内转化为高昂的医疗费用。一 降低这些风险的策略是在NICU住院期间喂养母亲自己的乳汁（母乳），因为 与剂量依赖性增强早期脑发育，更好的ND结果， 降低肥胖及其并发症的风险。观察性研究记录了健康和经济 但所有这些研究都受到无法在伦理上随机化的限制 VP婴儿接受不同剂量的维生素B1。虽然在前6个月的独家喂养， 尽管对所有婴儿都推荐使用维生素C，但VP婴儿的母亲在提供维生素C方面面临许多障碍。几乎 50%的母亲在NICU出院前，即婴儿满6个月之前， 年龄我们正在进行的由NIH资助的随机对照试验，“减少母亲自己接受的差异， 极低出生体重儿的母乳：一项经济干预”（ReDiabetes，R 01 MD 013969）旨在 测试经济干预的有效性，以支付产妇提供母乳喂养的费用， 新生儿重症监护室ReDiplomacy为干预组母亲提供了一个经济捆绑：免费的医院级电力 吸奶器租赁，免费从家里取吸奶器，每天花在吸奶器上的钱， 抵消产妇的机会成本。干预组和对照组的母亲都接受了标准的新生儿重症监护室特定的 哺乳期护理。这种干预的伦理随机化，以实现更高的NICU剂量， 干预小组提供了第一次机会，以获得实验证据的影响，健康 和经济成果。利用ReDiagnosis的随机设计， 本研究旨在评估ND（认知、语言和运动指数评分）、肥胖和肥胖持续时间。 喂养，总护理成本和成本效益，通过20个月的校正年龄，没有剩余 令人困惑的担忧此外，本研究将评估总持续时间与 喂养（在NICU和出院后）和早期儿童的结果使用一个强大的队列设计。本研究 提供了一个无与伦比的机会，以获得实验证据的影响，母乳喂养的早期 VP婴儿的儿童ND和肥胖，无不可测量的混杂因素。它将提供最高质量的 决策者的证据和必要的经济数据需要比较两个NICU哺乳 在ReDiplomacy中使用的策略。其影响将是优先投资于有效的战略， 为VP婴儿提供支持，并减少在接受治疗方面的不公平现象，最终改善 所有VP婴儿的结局。

Project Summary Although most very preterm (VP; <32 weeks gestation) infants survive to discharge from the neonatal intensive care unit (NICU), they remain at heightened risk for impaired neurodevelopment (ND), obesity and cardiometabolic conditions, burdening families and translating to high healthcare costs over the lifespan. One strategy to reduce these risks is to feed mother’s own milk (MOM) during the NICU hospitalization, because MOM is associated with a dose-dependent enhancement in early brain development, better ND outcomes, and a reduced risk of obesity and its complications. Observational studies have documented health and economic benefits associated with MOM, but all of these studies have been limited by the inability to ethically randomize VP infants to receive different doses of MOM. Although exclusive MOM feedings through the first 6 months of life are recommended for all infants, mothers of VP infants face numerous barriers in providing MOM. Almost 50% of mothers discontinue MOM provision before NICU discharge, well before their infants reach 6 months of age. Our ongoing NIH-funded randomized controlled trial, “Reducing disparity in the receipt of mother’s own milk in very low birthweight infants: An economic intervention” (ReDiMOM, R01MD013969) was designed to test the effectiveness of an economic intervention that covers the maternal costs of providing MOM in the NICU. ReDiMOM provides an economic bundle to intervention group mothers: free hospital grade electric breast pump rental, free pickup of pumped MOM from the home, and payment for each day spent pumping to offset maternal opportunity costs. Both intervention and control group mothers receive standard NICU-specific lactation care. This ethical randomization of an intervention to achieve higher NICU MOM doses in the intervention group provides the first opportunity to obtain experimental evidence of MOM’s impact on health and economic outcomes in early childhood. Leveraging the randomized design of ReDiMOM, the overall aim of this study is to assess ND (cognitive, language and motor index scores), adiposity, and duration of MOM feedings, total cost of care and cost-effectiveness through 20 months’ corrected age, without residual confounding concerns. Additionally, this study will assess the relationship between total duration of MOM feeding (in NICU and post discharge) and early childhood outcomes using a robust cohort design. This study provides an unparalleled opportunity to obtain experimental evidence of the effect of MOM feedings on early childhood ND and adiposity in VP infants without unmeasured confounding. It will provide the highest quality of evidence for decision makers and essential economic data needed to compare the two NICU lactation strategies employed in ReDiMOM. The impact will be on prioritizing investment in effective strategies that support MOM for VP infants and reduce inequities in the receipt of MOM, ultimately leading to improved outcomes for all VP infants.