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NCT06362798 · ClinicalTrials.gov registry record · NA
Effect of Support for Low-Income Mothers of Preterm Infants
A NA study of Preterm Birth and Low; Birthweight, Extremely (999 Grams or Less), sponsored by University of Massachusetts, Worcester.
- Recruiting
- Registry status
- NA
- Development phase
- 420
- Enrollment target
- 4
- Study locations
NCT06362798: Recruiting NA study of Preterm Birth and Low; Birthweight, Extremely (999 Grams or Less), sponsored by University of Massachusetts, Worcester.
NCT06362798 is a NA study of Preterm Birth and Low; Birthweight, Extremely (999 Grams or Less) that is actively recruiting participants, run by University of Massachusetts, Worcester. The registered enrollment target is 420 participants, below the 4,398-participant average among 39 other Preterm Birth trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06362798, a NA study of Preterm Birth and Low; Birthweight, Extremely (999 Grams or Less), is actively recruiting participants, sponsored by University of Massachusetts, Worcester.
- RECRUITING
- Registry status
- NA
- Development phase
- 420 participants
- Enrollment target
- 4
- Study locations
Study Summary
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 disad
Primary Outcome
Proportion of nursing shift-total enteral intake that is maternal breast milk fed via gavage tube or bottle.
Conditions Studied
Interventions
- OTHER Financial Transfers
Study Locations (4)
Massachusetts
- Boston Medical Center - Boston
- Baystate Medical Center - Springfield
- UMass Memorial Medical Center - Worcester
Georgia
- Children's Healthcare of Atlanta and Emory University - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2024-10-24 |
| Est. Completion | 2028-08-31 |
| Phase | NA |
What NCT06362798 shows while recruiting
NCT06362798 is an interventional study that assigns participants to a tested intervention. The registered 420 participants enrollment target is mid-sized for trials with a published cap, below the 4,398-participant average among 39 other Preterm Birth trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Preterm Birth appearing as the primary indexed condition, and to 1 intervention - of which Financial Transfers is the first listed.
NCT06362798 reports a single indexed study location in Massachusetts, Georgia.
Frequently Asked Questions
What is clinical trial NCT06362798 about?
NCT06362798 is a clinical study titled "Effect of Support for Low-Income Mothers of Preterm Infants". 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 ma...
What is the current status of trial NCT06362798?
This trial is currently recruiting. It is a NA study. The enrollment target is 420 participants. The study started on 2024-10-24. Estimated completion is 2028-08-31.
What conditions does trial NCT06362798 study?
This clinical trial studies the following conditions: Preterm Birth, Low; Birthweight, Extremely (999 Grams or Less).
What interventions are being tested in trial NCT06362798?
The interventions under investigation include: Financial Transfers (OTHER).
Who is sponsoring clinical trial NCT06362798?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06362798 being conducted?
This trial has 4 study locations across Georgia, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Preterm Birth
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06362798's enrollment target sits among peer trials
420 15th of 39 higher than 25 of 39 other Preterm Birth trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Preterm Birth trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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