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Community-Partnered Doula Support for Neonatal Intensive Care Unit Families

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Recruitment opened
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 15, 2026 to Mar 10, 2026
    v3
  2. Minor Secondary endpoints: details revised at 4 of 7 entries
    • Study description expanded, about 2 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn if pairing families who have a baby in the Neonatal Intensive Care Unit with a community doula improves stress. The main questions it aims to answer are: Researchers will compare stress levels among families with a baby in the neonatal intensive care unit who are paired with a community doula compared to those who receive standard care. Participants will: Complete baseline surveys and physical assessments (blood pressure and blood sample collection) and again after six weeks If they are randomized to receive doula support, they will meet with the doula weekly to receive additional parental support for six weeks
Trial Details
NCT Number NCT07437131
Lead Sponsor Women and Infants Hospital of Rhode Island
Conditions
(from sponsor)
Infant Admitted to Neonatal Intensive Care Unit (NICU), Doula Support
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov