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: 10528759
• 负责人: TRICIA J. JOHNSON
• 金额: $ 54.37万
• 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/10528759
• 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; Infant; Intake; Intelligence quotient; Intervention; Intervention Trial; Investments; Lactation; Language; Life; Longevity; Low Birth Weight Infant; Measures; Milk; Mothers; Motor; Neonatal Intensive Care Units; Nutritional; Obesity; Observational Study; Outcome; Pregnancy; Premature Infant; Pump; Randomized; Randomized Controlled Trials; Residual state; Risk; Translating; United States National Institutes of Health; Very Low Birth Weight Infant; Vulnerable Populations; base; breast pump; cardiometabolism; care costs; cohort; cost; cost effective; cost effectiveness; design; disparity reduction; early childhood; economic outcome; effectiveness testing; family burden; feeding; group intervention; health economics; high risk infant; 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 尽管大多数早产儿(VP；&lt；32周妊娠)存活到新生儿重症监护室出院。 护理病房(NICU)，他们仍然处于神经发育受损(ND)、肥胖和 心脏代谢性疾病，加重家庭负担，并在一生中导致高昂的医疗费用。一 降低这些风险的策略是在NICU住院期间喂养母亲自己的母乳，因为 MOM与早期脑发育的剂量依赖性增强、更好的ND结局和 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 与母亲相关的益处，但所有这些研究都受到无法在伦理上随机分组的限制 VP婴儿接受不同剂量的母亲。尽管独家妈妈在孩子出生后的前6个月一直在喂养 生活被推荐给所有的婴儿，VP婴儿的母亲在提供母亲方面面临着许多障碍。差不多了 50%的母亲在NICU出院前停止提供母亲服务，远远早于她们的婴儿达到 年龄。我们正在进行的由美国国立卫生研究院资助的随机对照试验，“减少接受母亲亲生子女的差异” 极低出生体重儿的母乳：经济干预“(ReDiMOM，R01MD013969)旨在 测试一项经济干预措施的有效性，该干预措施涵盖了在 新生儿重症监护室。ReDiMOM为干预组母亲提供经济捆绑：免费医院级电子产品 吸奶器租赁，免费从家里接吸奶器的妈妈，并支付每天用于吸奶器的费用 抵消母性机会成本。干预组和对照组的母亲都接受标准的NICU专科治疗 哺乳护理。这是一项干预措施的道德随机化，以实现更高的NICU MOM剂量 干预小组提供了第一个获得母亲对健康影响的实验证据的机会 以及儿童早期的经济成果。利用ReDiMOM的随机化设计， 这项研究旨在评估母亲的认知、语言和运动指数得分、肥胖和持续时间 喂养、护理总成本和20个月校正年龄期间的成本效益，无残留物 令人困惑的担忧。此外，这项研究将评估母亲的总持续时间与 使用稳健的队列设计，喂养(在NICU和出院后)和儿童早期结果。本研究 提供了一个无与伦比的机会来获得实验证据，证明母乳喂养对早产儿的影响 无测量混杂的VP婴儿的儿童期ND和肥胖。它将提供最高质量的 决策者的证据和比较两个NICU哺乳期所需的基本经济数据 在ReDiMOM中采用的策略。其影响将是对以下有效战略的优先投资 为VP婴儿提供MOM支持，减少在接受MOM方面的不平等，最终导致改善 所有VP婴儿的结局。