Effect of Support for Low-Income Mothers of Preterm Infants on Parental Caregiving in the Neonatal Intensive Care Unit (NICU)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 420
- 试验地点
- 4
- 主要终点
- Provision of breast milk (proportion)
研究概览
简要总结
Preterm birth is a leading cause of childhood mortality and developmental disabilities. Socioeconomic disparities in the incidence of preterm birth and morbidities, mortality, and quality of care for preterm infants persist. An important predictor of the long-term consequences of preterm birth is maternal presence during the prolonged infant hospitalization (weeks to months) in the neonatal intensive care unit (NICU). Mothers who visit the NICU can pump breast milk, directly breastfeed and engage in skin-to-skin care, which facilitates breast milk production and promotes infant physiologic stability and neurodevelopment. Low-income mothers face significant barriers to frequent NICU visits, including financial burdens and the psychological impact of financial stress, which hinder their participation in caregiving activities. The investigators will conduct an randomized controlled trial (RCT) to test the effectiveness of financial transfers among 420 Medicaid - eligible mothers with infants 24 - 34 weeks' gestation in four level 3 NICUs: Boston Medical Center (BMC) in Boston, Massachusetts, UMass Memorial Medical Center (UMass) in Worcester, Massachusetts, Baystate Medical Center in Springfield, Massachusetts, and Grady Memorial Hospital in Atlanta, Georgia. Mothers in the intervention arm will receive usual care enhanced with weekly financial transfers and will be informed that these transfers are meant to help them spend more time with their infant in the NICU vs. a control arm (usual care). We received supplemental funding to extend analyses to include extended postpartum maternal health outcomes. The original sample size of 420 remains the basis for the parent trial's primary and secondary NICU caregiving outcomes, while the supplemental funding (effective January 2026) enables analysis of secondary maternal health outcomes up to 12 months postpartum using an expanded analytic cohort. The primary hypothesis is that financial transfers can enable economically disadvantaged mothers to visit the NICU, reduce the negative psychological impacts of financial distress, and increase maternal caregiving behaviors associated with positive preterm infant health and development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Enrolled mothers who are assigned to the intervention group will be informed to not discuss the financial transfers with anyone on the NICU care team (i.e., physicians, nurses, etc.)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mother is eligible for Medicaid insurance.
- •Has an infant or infants born 24 0/7-34 1/7 weeks gestation.
- •Mother's baby is cared for at one of the four enrolling study sites located in Massachusetts or Georgia.
- •Mother is eligible to breastfeed (per hospital criteria).
排除标准
- •Mother is not English- or Spanish-speaking.
结局指标
主要结局
Provision of breast milk (proportion)
时间窗: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Proportion of nursing shift-total enteral intake that is maternal breast milk fed via gavage tube or bottle.
Provision of skin-to-skin care
时间窗: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)
Proportion of nursing shifts where mother performs skin-to-skin care for at least one hour.
次要结局
- Duration of mother's milk expression(From NICU admission through to 12 months postpartum)
- Gestational weight-for-age(Extracted from medical records 1-2 weeks after discharge from the NICU)
- Maternal mental health (anxiety)(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
- Maternal mental health (depression)(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
- Accuracy Performance Attention Network Test-Revised (ANT-R).(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks))
- Gestational weight-for-age(Extracted from medical records 1-2 weeks after discharge from the NICU)
- Gestational length-for-age z-score(Extracted from medical records 1-2 weeks after discharge from the NICU)
- Necrotizing enterocolitis (NEC)(Extracted from medical records 1-2 weeks after discharge from the NICU)
- Late-onset bacterial or fungal sepsis (LOS)(Extracted from medical records 1-2 weeks after discharge from the NICU)
- NICU Visitation(From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks))
- Postpartum Bonding(Measured in the post-discharge survey within 4-8 week of infant discharge)
- Reaction Time Attention Network Test-Revised (ANT-R).(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks))
- Reaction Time Psychomotor Vigilance Task(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks))
- Accuracy Psychomotor Vigilance Task(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks))
- Length of stay(Measured within one week of discharge form the NICU)
- Mother readmission between 4-8 weeks post-discharge(Measured between 4-8 weeks after discharge of infant from NICU)
- Baby readmission between 4-8 weeks post-discharge(Measured between 4-8 weeks after discharge of infant from NICU)
- Sleep position(Measured between 4-8 weeks after discharge of infant from NICU)
- Sleep location(Measured between 4-8 weeks after discharge of infant from NICU)
- Breastfeeding expression continuation(Measured between 4-8 weeks after discharge of infant from NICU)
- Skin-to-skin care knowledge(Measured within one week of discharge form the NICU)
- Breastfeeding knowledge(Measured within one week of discharge form the NICU)
- Perception of hospital experience(Measured between 4-8 weeks after discharge of infant from NICU)
- Gestational length-for-age z-score(Extracted from medical records 1-2 weeks after discharge from the NICU)
- Gestational head circumference(Extracted from medical records 1-2 weeks after discharge from the NICU)
- Necrotizing enterocolitis (NEC)(Extracted from medical records 1-2 weeks after discharge from the NICU)
- Late-onset bacterial or fungal sepsis (LOS)(Extracted from medical records 1-2 weeks after discharge from the NICU)
- NICU Visitation(From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks))
- Postpartum Bonding(Measured in the post-discharge survey within 4-8 week of infant discharge)
- Provision of breast milk (volume)(From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks))
- Breastfeeding episode(From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks))
- Maternal physical health(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
- Reaction Time Attention Network Test-Revised (ANT-R).(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks))
- Accuracy Performance Attention Network Test-Revised (ANT-R).(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks))
- Reaction Time Psychomotor Vigilance Task(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks))
- Accuracy Psychomotor Vigilance Task(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks))
- Happiness(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
- Life satisfaction(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
- Sleep(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
- Routine postpartum care(Measured at post-discharge (4-8 weeks after infant discharge from NICU); 6 months postpartum; 12 months postpartum)
- Financial distress(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
- Financial hardship(Measured within one week of discharge form the NICU; post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
- Food insecurity(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
- Housing instability(Measured within one week of discharge form the NICU; post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
- Housing insecurity(Measured within one week of discharge form the NICU; post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
- Transportation insecurity(Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
- Length of stay(Measured within one week of discharge form the NICU)
- Mother readmission between 4-8 weeks post-discharge(Measured between 4-8 weeks after discharge of infant from NICU)
- Baby readmission between 4-8 weeks post-discharge(Measured between 4-8 weeks after discharge of infant from NICU)
- Mother emergency department visit post-discharge(Measured at post-discharge survey (4-8 weeks after infant discharge from NICU); 6 months postpartum; 12 months postpartum)
- Baby emergency department visit weeks post-discharge(Measured at post-discharge survey (4-8 weeks after infant discharge from NICU); 6 months postpartum; 12 months postpartum)
- Sleep position(Measured between 4-8 weeks after discharge of infant from NICU)
- Sleep location(Measured between 4-8 weeks after discharge of infant from NICU)
- Breastfeeding expression continuation(Measured between 4-8 weeks after discharge of infant from NICU)
- Skin-to-skin care knowledge(Measured within one week of discharge form the NICU)
- Breastfeeding knowledge(Measured within one week of discharge form the NICU)
- Perception of hospital experience(Measured between 4-8 weeks after discharge of infant from NICU)
- Life's Essential 8 (LE8) behavioral cardiovascular health score(Measured at pre-discharge; post-discharge (4-8 weeks, where all components are available); 6 months postpartum; 12 months postpartum)
- Primary care utilization in the postpartum period(Measured at post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
- Adherence to recommended care for chronic conditions(Measured at post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum)
研究者
Margaret Parker
Professor of Pediatrics
University of Massachusetts, Worcester