NCT06362798 · University of Massachusetts, Worcester
Effect of Support for Low-Income Mothers of Preterm Infants
What this study is 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.
View original scientific 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.
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 42 weeks corrected age.
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)
Proportion of nursing shift-total enteral intake that is maternal breast milk fed via gavage tube or bottle.
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)
Proportion of nursing shifts where mother performs skin-to-skin care for at least one hour.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Atlanta, Georgia
- Boston, Massachusetts
- Springfield, Massachusetts
- Worcester, Massachusetts
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 8, 2026 · Source of record for eligibility and locations