About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Mother is not English- or Spanish-speaking.
Trial design
Parallel
Treatments tested in this trial
Financial Transfers
Other interventionMothers assigned to the intervention group will be informed that they are eligible to receive financial transfers $160/week on a debit-card with a one-time "label" or scripted message that states: "This money is intended to help you to spend more time visiting and caring for your infant(s) in the NICU." Financial transfers will begin 1 week after birth or when the mother is discharged (whichever comes later) until the infant is discharged, except in cases where the hospitalization lasts beyond 42 weeks corrected age.
Treatment groups
Trial outcomes
Primary outcomes
Provision of breast milk (proportion)
Proportion of nursing shift-total enteral intake that is maternal breast milk fed via gavage tube or bottle.
Provision of skin-to-skin care
Proportion of nursing shifts where mother performs skin-to-skin care for at least one hour.
Secondary outcomes
Duration of mother's milk expression
Months of milk expression via direct breastfeeding or pumping.
Gestational weight-for-age
Change in sex-specific gestational weight-for-age z-score while admitted to the NICU.
Gestational length-for-age z-score
Change in sex-specific gestational length-for-age z-score while admitted to the NICU.
Gestational head circumference
Change in sex-specific gestational head circumference z-score while admitted to the NICU.
Sponsors and contacts
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University of Massachusetts, Worcester
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator