Effect of Support for Low-Income Mothers of Preterm Infants

Official title

Effect of Support for Low-Income Mothers of Preterm Infants on Parental Caregiving in the Neonatal Intensive Care Unit (NICU)

Overview

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.

Interventions

• Other 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 4

Primary outcome measures

• 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)]

Secondary outcome measures (12)

• Duration of mother's milk expression [Time frame: From NICU admission through to 12 months postpartum]
• Gestational weight-for-age [Time frame: Extracted from medical records 1-2 weeks after discharge from the NICU]
• Gestational length-for-age z-score [Time frame: Extracted from medical records 1-2 weeks after discharge from the NICU]
• Gestational head circumference [Time frame: Extracted from medical records 1-2 weeks after discharge from the NICU]
• Necrotizing enterocolitis (NEC) [Time frame: Extracted from medical records 1-2 weeks after discharge from the NICU]
• Late-onset bacterial or fungal sepsis (LOS) [Time frame: Extracted from medical records 1-2 weeks after discharge from the NICU]
• NICU Visitation [Time frame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)]
• Postpartum Bonding [Time frame: Measured in the post-discharge survey within 4-8 week of infant discharge]
• Provision of breast milk (volume) [Time frame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)]
• Breastfeeding episode [Time frame: From NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks)]
• Maternal physical health [Time frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum]
• Maternal mental health (anxiety) [Time frame: Measured biweekly from NICU admission to discharge or 42 weeks corrected gestational age, whichever comes earlier (maximum of 18 weeks); post-discharge (4-8 weeks); 6 months postpartum; 12 months postpartum]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

United States · 4 centers

• Children's Healthcare of Atlanta and Emory University — Atlanta
• Boston Medical Center — Boston
• Baystate Medical Center — Springfield
• UMass Memorial Medical Center — Worcester

Publications

• 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 Pe PMID 40375176

Identifiers

NCT: NCT06362798 · Study00001150 · 1R01HD109293-01 · 6-23FY-0012

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗