Effect of Support for Low-Income Mothers of Preterm Infants (NCT06362798)
Effect of Support for Low-Income Mothers of Preterm Infants on Parental Caregiving in the Neonatal Intensive Care Unit (NICU)
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Children's Healthcare of Atlanta and Emory University โ Atlanta, Georgia
Age range: 18 Years
๐งช Interventions in This Study
- Financial Transfers (OTHER)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (4 Sites)
- Children's Healthcare of Atlanta and Emory University โ Atlanta, Georgia
- Boston Medical Center โ Boston, Massachusetts
- Baystate Medical Center โ Springfield, Massachusetts
- UMass Memorial Medical Center โ Worcester, Massachusetts
๐ Contact the Study Coordinator
Phone: (203) 745-8321
Email: mmcconne@hsph.harvard.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Preterm Birth
- Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development โ Boston, Massachusetts
- Omega Tots Long Term Follow-up โ Columbus, Ohio
- Nurse-Family Partnership Impact Evaluation in South Carolina โ Anderson, South Carolina
- Promoting Kangaroo Care for Preterm or Low Birthweight Infants in Rural India โ Worcester, Massachusetts
- The Use of Wireless Sensors in Neonatal Intensive Care โ Montreal, Quebec
- Music Intervention for Preterm Birth โ New York, New York
Explore by condition: All Preterm Birth clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.