Effect of Support for Low-Income Mothers of Preterm Infants

NCT ID: NCT06362798

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-24
• Study Completion Date: 2028-08-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Financial Transfers

Intervention Type: 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.

Usual Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Margaret Parker

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Margaret Parker, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Memorial Health

Margaret McConnell, PhD

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

Children's Healthcare of Atlanta and Emory University

Atlanta, Georgia, United States

Site Status: RECRUITING

Boston Medical Center

Boston, Massachusetts, United States

Site Status: RECRUITING

Baystate Medical Center

Springfield, Massachusetts, United States

Site Status: RECRUITING

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Margaret McConnell, PhD

Role: CONTACT

mmcconne@hsph.harvard.edu

203-745-8321

Facility Contacts

Michelle-Marie Peña, MD

Role: primary

michelle.marie.pena@emory.edu

Gabriela Cordova Ramos, MD

Role: primary

gabriela.CordovaRamos@bmc.org

Laura Madore, MD

Role: primary

laura.Madore@baystatehealth.org

Margaret Parker, MD

Role: primary

margaret.Parker@umassmemorial.org

References

McConnell M, Alsager A, Fuchu P, Sriprasad S, Simoncini L, Drainoni ML, Cordova-Ramos EG, Pena MM, Madore L, Kalluri NS, Silverstein M, Schofield H, Farah MJ, Fink G, Parker MG. 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). BMC Pediatr. 2025 May 15;25(1):383. doi: 10.1186/s12887-025-05621-9.

Reference Type: DERIVED

PMID: 40375176 (View on PubMed)

Other Identifiers

1R01HD109293-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

6-23FY-0012

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Study00001150

Identifier Type: -

Identifier Source: org_study_id