Reducing Disparity in Receipt of Mother’s Own Milk in Very Low Birth Weight Infants: An Economic Intervention to Improve Adherence to Sustained Maternal Breast Pump Use

减少极低出生体重婴儿接受母乳的差异：提高母亲持续使用吸奶器依从性的经济干预措施

• 批准号: 9979609
• 负责人: TRICIA J. JOHNSON
• 金额: $ 66.14万
• 依托单位: RUSH UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-18 至 2024-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9979609
• 关键词: Address; Adherence; Adopted; Adoption; Affect; African American; Asians; Behavior; Benchmarking; Birth; Birth Weight; Bronchopulmonary Dysplasia; Child; Cost Analysis; Cost Effectiveness Analysis; Data; Deposition; Dose; Economics; Effectiveness of Interventions; Employee; Equipment; Family; Funding; Goals; Health; Hispanics; Home environment; Hospitalization; Hospitals; Hour; Household Heads; Human Milk; Incentives; Infant; Infant formula; Inferior; Infrastructure; International; Intervention; Lactation; Life; Low Birth Weight Infant; Low income; Maternal Behavior; Measures; Mediating; Milk; Morbidity - disease rate; Mothers; Native Americans; Necrotizing Enterocolitis; Neonatal Intensive Care Units; Neurodevelopmental Problem; Not Hispanic or Latino; Outcome; Population; Poverty; Pump; Quality Indicator; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Regimen; Research; Risk; Risk Reduction; Sepsis; Testing; Time; Training; Transportation; United States National Institutes of Health; Very Low Birth Weight Infant; Work; authority; base; breast pump; comparative cost effectiveness; control trial; cost; cost effectiveness; disparity reduction; economic evaluation; emotional distress; feeding; hospital readmission; improved; infant outcome; innovation; late onset sepsis; maternal outcome; milk volume; novel; opportunity cost; pasteurization; payment; primary outcome; response; secondary outcome; standard of care

Project Summary In the US, the burden of very low birth weight (VLBW; <1500 g) birth is borne disproportionately by black (non-Hispanic black/African American) mothers who are 2.2-2.6 times more likely than nonblack mothers to deliver VLBW infants, with 31% of all VLBW infants born to black mothers. This disparity is amplified because black VLBW infants are significantly less likely to receive mother’s own milk (MOM) feedings from birth until neonatal intensive care unit (NICU) discharge than nonblack infants, which precludes exclusive MOM feedings for the first 6 months of life as recommended by authorities and adds to the lifelong burden of VLBW birth. In addition, VLBW infants are susceptible to potentially preventable morbidities including late onset sepsis, necrotizing enterocolitis, bronchopulmonary dysplasia and long-term neurodevelopmental problems, which all increase risks of rehospitalization. A dose-response relationship exists between the amount of MOM feedings and a reduction in the risk of these morbidities and their associated costs, with the greatest risk reduction for all four morbidities afforded by high-dose MOM through to NICU discharge. Even though black mothers of VLBW infants initiate MOM provision at rates similar to nonblack mothers and have similar goals to sustain MOM provision through to NICU discharge, there is a significant disparity in MOM feedings at NICU discharge. Only the mother can mitigate the disparity in MOM feedings at NICU discharge for the VLBW infant, and this maternal behavior involves adhering to a two-part regimen: 1) sustaining breast pump use (6-8 times/day) for the entire NICU hospitalization (average = 73 days), and 2) transporting the MOM that is pumped in the home to the NICU for infant feedings. These behaviors are associated with out-of-pocket and opportunity costs that are borne by mothers, unlike inferior feeding alternatives such as donor human milk and formula, which are paid for by NICUs. This randomized control trial will test an intervention (NICU acquires MOM) developed to facilitate maternal adherence to this two-part regimen by offsetting the aforementioned costs that serve as barriers to sustaining MOM feedings: a) free hospital-grade electric breast pump, b) pickup of MOM, and c) payment for opportunity costs compared to current standard of care (mother provides MOM). The primary outcome will be receipt of MOM at NICU discharge, with secondary outcomes of volume of MOM pumped and total duration of pumping, infant’s receipt of any MOM feedings, duration of MOM feedings, and cumulative dose of MOM received at NICU discharge. Cost analyses will be performed to: 1) describe and compare the cost of the NICU acquiring MOM versus NICU acquiring donor human milk if MOM is not available; and 2) compare the cost effectiveness of NICU acquiring MOM versus mother providing MOM. This innovative trial will determine the effectiveness of the intervention in reducing the disparity in MOM feedings and provide an economic analysis of the interventions, yielding critical data impacting generalizability and likelihood of implementation of results.

项目摘要 在美国，极低出生体重（VLBW; <1500 g）的负担由以下人群不成比例地承担： 黑人（非西班牙裔黑人/非裔美国人）母亲比非黑人母亲高2.2-2.6倍 在所有极低出生体重婴儿中，黑人母亲所生的婴儿占31%。这种差距被放大了 因为黑人极低出生体重婴儿明显不太可能接受母亲自己的牛奶（母乳）喂养， 出生直到新生儿重症监护室（NICU）出院的婴儿比非黑人婴儿多，这排除了排他性的歧视。 根据当局的建议，在出生后的前6个月进行喂养，并增加了VLBW的终身负担 出生此外，极低出生体重婴儿易患潜在可预防的疾病，包括晚发型 败血症、坏死性小肠结肠炎、支气管肺发育不良和长期神经发育问题， 这些都增加了再次住院的风险。剂量-反应关系存在于 喂养和降低这些疾病的风险及其相关费用， 通过高剂量治疗至NICU出院，所有四种发病率均降低。 即使极低出生体重婴儿的黑人母亲开始提供母乳喂养的比率与非黑人母亲相似， 并有类似的目标，以维持通过新生儿重症监护室出院的供应，有一个显着的差异， 在NICU出院时停止喂食。只有母亲才能减轻新生儿重症监护室婴儿喂养的差异 极低出生体重婴儿出院，这种母亲行为涉及遵守两部分方案：1） 在整个NICU住院期间（平均= 73天）持续使用吸奶器（6-8次/天），以及2） 将在家中泵送的母乳运送到NICU用于婴儿喂养。这些行为是 与低质量喂养不同， 替代品，如捐赠母乳和配方奶粉，由新生儿重症监护病房支付。这项随机对照试验 将测试一种干预措施（NICU获得新生儿监护），以促进产妇遵守这两部分 通过抵消上述阻碍维持MOM喂养的成本来实施方案：a）免费 医院级电动吸奶器，B）取奶，以及c）与 目前的护理标准（母亲提供护理）。主要结局将是在NICU接受治疗 出院，次要结局为泵送的羊水量和泵送的总持续时间，婴儿接受 任何母乳喂养、母乳喂养持续时间和NICU出院时接受的母乳喂养累积剂量。 将进行成本分析，以：1）描述并比较NICU获得手术的成本， 如果没有母乳喂养，新生儿重症监护室（NICU）获取供体母乳; 2）比较新生儿重症监护室（NICU）的成本效益 获得维生素A与母亲提供维生素A的对比。这一创新试验将决定 采取干预措施，减少母乳喂养方面的差距，并对干预措施进行经济分析， 产生影响成果的普遍性和执行可能性的关键数据。