Effect of Support for Low-Income Mothers of Preterm Infants

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
University of Massachusetts, Worcester
Study ID
NCT06362798
Status
Recruiting
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Conditions

  • Low; Birthweight, Extremely (999 Grams or Less)
  • Preterm Birth

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Financial Transfers — OTHER
    Mothers 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.

Study Details

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 Dates

Start date
Oct 24, 2024
Status verified
Jan 2026
Primary completion
Jul 1, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Financial Transfers
    Mothers assigned to the intervention group will be informed that they are eligible to receive financial transfers $160/week on a "CuddleCard" 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.
  • No Intervention: Usual Care

Primary Outcome Measure

Provision of breast milk (proportion) [ Time Frame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks) ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Children's Healthcare of Atlanta and Emory UniversityAtlantaGeorgia30322
Michelle-Marie Peña, MD
[email protected]
Boston Medical CenterBostonMassachusetts02118
Gabriela Cordova Ramos, MD
[email protected]
Baystate Medical CenterSpringfieldMassachusetts01199
Laura Madore, MD
[email protected]
UMass Memorial Medical CenterWorcesterMassachusetts01605
Margaret Parker, MD
[email protected]

Find similar trials in Atlanta, GA

By research site
Children's Healthcare of Atlanta and Emory University· Atlanta, GABoston Medical Center· Boston, MABaystate Medical Center· Springfield, MAUMass Memorial Medical Center· Worcester, MA

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