Recruiting

Observational Study

Sponsor:

University of Massachusetts, Worcester

Code:

NCT06362798

Conditions

Preterm Birth

Low; Birthweight, Extremely (999 Grams or Less)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Financial Transfers

Study Details

Brief summary:

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

Preterm Birth

Low; Birthweight, Extremely (999 Grams or Less)

Study ID

NCT06362798

Start date

Oct 24, 2024

Status verified date

Jan, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Mother is not English- or Spanish-speaking.

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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

Interventions

Financial Transfers

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.

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) ]
  • Provision of skin-to-skin care [ Time Frame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks) ]

Central Contacts and Locations

Central contacts

Locations

Children's Healthcare of Atlanta and Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Michelle-Marie Peña, MD

michelle.marie.pena@emory.edu

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Gabriela Cordova Ramos, MD

gabriela.CordovaRamos@bmc.org

Baystate Medical Center

Recruiting

Springfield, Massachusetts, United States, 01199

Contacts

UMass Memorial Medical Center

Recruiting

Worcester, Massachusetts, United States, 01605

Contacts

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-01-08.