NCT06362798

Effect of Support for Low-Income Mothers of Preterm Infants

Recruiting now NA Last updated 8 January 2026

What this trial tests

NA trial testing Financial Transfers in Preterm Birth in 420 participants. Currently enrolling.

Timeline

24 October 2024

Primary endpoint
1 July 2028

31 August 2028

Quick facts

Lead sponsor	University of Massachusetts, Worcester
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	420
Start date	24 October 2024
Primary completion	1 July 2028
Estimated completion	31 August 2028
Sites	4 locations across United States

Drugs / interventions tested

• Financial Transfers

Conditions studied

• Preterm Birth — all drugs for Preterm Birth →
• Low; Birthweight, Extremely (999 Grams or Less) — all drugs for Low; Birthweight, Extremely (999 Grams or Less) →

Sponsor

University of Massachusetts, Worcester

Who can join

18 and older, female only, with Preterm Birth or Low; Birthweight, Extremely (999 Grams or Less). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Necrotizing Enterocolitis: What's New and What's Next?
   Sha C, Sander WR, Bass K, Hsieh H, et al · · 2025 · cited 1× · PMID 41096926 · DOI 10.3390/ijms26199660
2. CuddleCard: Protocol for a randomized controlled trial evaluating the effect of providing financial support to low-income mothers of preterm infants on parental caregiving in the neonatal intensive care unit (NICU).
   McConnell M, Alsager A, Fuchu P, Sriprasad S, et al · · 2025 · PMID 40375176 · DOI 10.1186/s12887-025-05621-9