Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06362798

Effect of Support for Low-Income Mothers of Preterm Infants

Led by University of Massachusetts, Worcester · Updated on 2026-01-08

420

Participants Needed

4

Research Sites

201 weeks

Total Duration

On this page

Sponsors

U

University of Massachusetts, Worcester

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Effect of Support for Low-Income Mothers of Preterm Infants

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Mother is eligible for Medicaid insurance.
  • Has an infant or infants born 24 0/7 to 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 according to hospital criteria.
Not Eligible

You will not qualify if you...

  • Mother is not English- or Spanish-speaking.

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Trial Site Locations

Total: 4 locations

1

Children's Healthcare of Atlanta and Emory University

Atlanta, Georgia, United States, 30322

Actively Recruiting

2

Boston Medical Center

Boston, Massachusetts, United States, 02118

Actively Recruiting

3

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

Actively Recruiting

4

UMass Memorial Medical Center

Worcester, Massachusetts, United States, 01605

Actively Recruiting

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Research Team

M

Margaret McConnell, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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