Effect of Support for Low-Income Mothers of Preterm Infants

P

President and Fellows of Harvard College

Status

Not yet enrolling

Conditions

Low; Birthweight, Extremely (999 Grams or Less)
Preterm Birth

Treatments

Other: Financial Transfers

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06362798
1R01HD109293-01 (U.S. NIH Grant/Contract)
6-23FY-0012 (Other Grant/Funding Number)
IRB22-0729

Details and patient eligibility

About

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 - 33 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). 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.

Enrollment

420 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Mother is eligible for Medicaid insurance.
  • Has an infant or infants born 24-33 weeks gestation.
  • Mother is eligible to breastfeed (per hospital criteria).

Exclusion criteria

Mother is not English- or Spanish-speaking.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

420 participants in 2 patient groups

Financial Transfers
Experimental group
Description:
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.
Treatment:
Other: Financial Transfers
Usual Care
No Intervention group

Trial contacts and locations

4

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Central trial contact

Margaret McConnell, PhD

Data sourced from clinicaltrials.gov

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