Purpose

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.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
Female
Accepts Healthy Volunteers
No

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-speaking. - Mother is not a resident of Massachusetts or Georgia.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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.
Primary Purpose
Health Services Research
Masking
Double (Care Provider, Outcomes Assessor)
Masking Description
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.)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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 42 weeks corrected age.
No Intervention
Usual Care

Recruiting Locations

Boston Medical Center
Boston, Massachusetts 02118
Contact:
Gabriela Cordova Ramos, MD
gabriela.CordovaRamos@bmc.org

More Details

Status
Recruiting
Sponsor
University of Massachusetts, Worcester

Study Contact

Margaret McConnell, PhD
203-745-8321
mmcconne@hsph.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.