Postpartum Care in the NICU (PeliCaN) Transitions

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT06521398
Status
Recruiting
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Conditions

  • Postpartum Anxiety
  • Postpartum Depression
  • Premature Birth
  • Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex
FEMALE
Age
16 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Doula Support — OTHER
    Doula support including care coordination to mental and medical health services in the NICU, with a warm handoff to a community doula to continue the support once infants leave the HUP NICU.

Study Details

This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.

Key Dates

Start date
Sep 11, 2024
Status verified
Oct 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Doula Intervention
    Participants randomized to the intervention will be offered doula support including care coordination to mental and medical health services in the neonatal intensive care unit (NICU), with a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.
  • No Intervention: Control
    Participants randomized to usual care will get the same care they normally would with their own provider, outside of research enrollment, and receive a resource guide with information about the importance of postpartum follow-up care.

Primary Outcome Measure

Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Heather Burris, MD MPH
[email protected]
(215) 573-4916
Niesha Darden
[email protected]

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By research site
Hospital of the University of Pennsylvania· Philadelphia, PA

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