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

减少母乳差异 (ReDiMOM) 试验对原极低出生体重婴儿的早期儿童神经发育、经济和营养结果

• 批准号: 10705312
• 负责人: TRICIA J. JOHNSON
• 金额: $ 49.86万
• 依托单位: RUSH UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10705312
• 关键词: Adherence; Age; Age Months; Brain; Caring; Cognitive; Collection; Control Groups; Data; Data Collection; Development; Dose; Economics; Effectiveness; Ethics; Event; Face; Funding; Health; Health Care Costs; Home; Hospitalization; Hospitals; Impairment; Inequity; Infant; Intake; Intelligence quotient; Intervention; Intervention Trial; Investments; Lactation; Language; Life; Longevity; Measures; Milk; Mothers; Motor; Neonatal Intensive Care Units; Nutritional; Obesity; Observational Study; Outcome; Pregnancy; Premature Infant; Pump; Randomized; Randomized, Controlled Trials; Recommendation; Residual state; Risk; Risk Reduction; Translating; United States National Institutes of Health; Very Low Birth Weight Infant; Vulnerable Populations; breast pump; cardiometabolism; care costs; cohort; comparison control; cost; cost comparison; cost effective; cost effectiveness; design; disparity reduction; early childhood; economic outcome; effectiveness testing; extreme prematurity; family burden; feeding; group intervention; high risk infant; improved; improved outcome; indexing; milk intake; neurodevelopment; obesity risk; opportunity cost; payment; primary outcome; therapy design; treatment group

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.

项目摘要 尽管大多数非常早产（vp; <32周妊娠）婴儿能够从新生儿密集型 护理部门（NICU），他们仍然处于神经发育受损（ND），肥胖和 心脏代谢条件，燃烧家庭并转化为寿命中的高医疗保健费用。一 降低这些风险的策略是在NICU住院期间喂母亲自己的牛奶（妈妈），因为 妈妈在早期大脑发育，更好的结果和 观察风险及其并发症的风险降低。观察性研究已经记录了健康和经济 与妈妈有关 副总裁婴儿接受不同剂量的妈妈。虽然在前6个月中的独家妈妈喂养 建议所有婴儿的生活，副总裁婴儿的母亲在提供妈妈时面临许多障碍。几乎 50％的母亲在NICU出院前停止妈妈的规定，早在婴儿到6个月之前 年龄。我们正在进行的NIH资助的随机对照试验，“在收到母亲的差异 非常低的出生体重婴儿的牛奶：经济干预”（Redimom，R01MD013969）旨在 测试经济干预的有效性，该干预措施涵盖了在 尼克斯。 Redimom为母亲提供了一个经济束缚：免费医院级电气 吸奶器租金，免费从家里抽水的妈妈接送，以及每天花费的付款 抵消母亲的机会成本。干预和对照组的母亲都会获得标准的NICU特异性 哺乳护理。这种干预措施的道德随机化在 干预小组提供了第一个机会，以获取妈妈对健康影响的实验证据 和幼儿期的经济成果。利用Redimom的随机设计，这是 这项研究是为了评估ND（认知，语言和运动指数得分），肥胖和妈妈的持续时间 在20个月的校正年龄之前，喂养，总护理成本和成本效益，无剩余 令人困惑的问题。此外，这项研究将评估妈妈的总持续时间之间的关系 使用强大的队列设计（在NICU和出院后）和幼儿结局。这项研究 提供了无与伦比的机会来获得妈妈喂养对早期影响的实验证据 副总裁婴儿的童年和肥胖，而没有无法忍受的混淆。它将提供最高质量 比较两种NICU泌乳所需的决策者和基本经济数据的证据 Redimom采用的策略。影响将是对对有效策略进行投资的优先级，这些策略 为副总裁婴儿提供支持，并减少妈妈的不平等现象，最终导致改善 所有VP婴儿的结果。