RECRUITING

Effect of Support for Low-Income Mothers of Preterm Infants

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-10-24
Study Completion:2028-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06362798

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Mother is eligible for Medicaid insurance.
  2. * Has an infant or infants born 24 0/7-34 1/7 weeks gestation.
  3. * Mother's baby is cared for at one of the four enrolling study sites located in Massachusetts or Georgia.
  4. * Mother is eligible to breastfeed (per hospital criteria).
  1. * Mother is not English- or Spanish-speaking.

Contacts and Locations

Study Contact

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

Principal Investigator

Margaret Parker, MD
PRINCIPAL_INVESTIGATOR
UMass Memorial Health
Margaret McConnell, PhD
PRINCIPAL_INVESTIGATOR
Harvard School of Public Health (HSPH)

Study Locations (Sites)

Children's Healthcare of Atlanta and Emory University
Atlanta, Georgia, 30322
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
Baystate Medical Center
Springfield, Massachusetts, 01199
United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01605
United States

Collaborators and Investigators

Sponsor: University of Massachusetts, Worcester

  • Margaret Parker, MD, PRINCIPAL_INVESTIGATOR, UMass Memorial Health
  • Margaret McConnell, PhD, PRINCIPAL_INVESTIGATOR, Harvard School of Public Health (HSPH)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-24
Study Completion Date2028-08-31

Study Record Updates

Study Start Date2024-10-24
Study Completion Date2028-08-31

Terms related to this study

Additional Relevant MeSH Terms

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