Effect of Support for Low-Income Mothers of Preterm Infants

Recruiting now · Not applicable

Conditions studied: Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less)

In brief

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.

Key facts

Study ID

NCT06362798

Run by

University of Massachusetts, Worcester

People needed

420

Starts

2024-10-24

Expected to finish

2028-08-31

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• Mother is not English- or Spanish-speaking.

Where it is running

• Children's Healthcare of Atlanta and Emory University — Atlanta, Georgia, United States (enrolling)
• Boston Medical Center — Boston, Massachusetts, United States (enrolling)
• Baystate Medical Center — Springfield, Massachusetts, United States (enrolling)
• UMass Memorial Medical Center — Worcester, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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