Effect of Support for Low-Income Mothers of Preterm Infants

NCT06362798 | Recruiting

• 3 other identifiers: Study000011501R01HD109293-016-23FY-0012
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 4

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)

Outcome Measures

Primary Outcomes (2)

• Provision of breast milk (proportion)

  Proportion of nursing shift-total enteral intake that is maternal breast milk fed via gavage tube or bottle.

  From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)

• Provision of skin-to-skin care

  Proportion of nursing shifts where mother performs skin-to-skin care for at least one hour.

  From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)

Secondary Outcomes (41)

• Duration of mother's milk expression

  From NICU admission through to 12 months postpartum

• Gestational weight-for-age

  Extracted from medical records 1-2 weeks after discharge from the NICU

• Gestational length-for-age z-score

  Extracted from medical records 1-2 weeks after discharge from the NICU

• Gestational head circumference

  Extracted from medical records 1-2 weeks after discharge from the NICU

• Necrotizing enterocolitis (NEC)

  Extracted from medical records 1-2 weeks after discharge from the NICU

Study Arms (2)

Financial Transfers

EXPERIMENTAL

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.

Other: Financial Transfers

Usual Care

NO INTERVENTION

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.

Financial Transfers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Mother is not English- or Spanish-speaking.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

Children's Healthcare of Atlanta and Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

RECRUITING

UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40375176 DERIVED

MeSH Terms

Conditions

Premature Birth; Birth Weight

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Margaret Parker, MD

  UMass Memorial Health

  PRINCIPAL INVESTIGATOR

• Margaret McConnell, PhD

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret McConnell, PhD

CONTACT

203-745-8321; mmcconne@hsph.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Enrolled mothers who are assigned to the intervention group will be informed to not discuss the financial transfers with anyone on the NICU care team (i.e., physicians, nurses, etc.)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Two-arm single-blind 1:1 randomized controlled trial of financial transfers ($160 per week) versus usual care. Mothers in the intervention arm will access videos that explain the impact of the cash on their availability for benefits and social supports. They will also be able to ask questions to a benefits counselor about how the transfers affect their benefits during the trial.

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: April 12, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (4)