Postpartum Care in the NICU (PeliCaN) Transitions

NCT06521398 · University of Pennsylvania

Recruiting

In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study

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.

Eligibility criteria

Inclusion Criteria: * HUP postpartum patients who are at least 16 years old at the time their newborns' birth * Infant born at HUP * Preterm birth \<34 weeks * English language speaking Exclusion Criteria: * Unable to read or sign informed consent * Parents of infants transferred into HUP NICU * If the medical team believes that the infant may not live or be transferred to another hospital in upcoming weeks * HUP postpartum patients who are less than 16 years of age at the time of their newborns' birth

Study design

Enrollment target: 20 participants

Allocation: randomized

Masking: none

Age groups: child, adult, older_adult

Timeline

Starts: 2024-09-11

Estimated completion: 2027-08

Last updated: 2025-10-14

Interventions

Other: Doula Support

Primary outcomes

• Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum (6 months)
• Number of participants who have attendance with a primary care provider by 6 months postpartum (6 months)

Sponsor

University of Pennsylvania · other

Contacts & investigators

ContactHeather Burris, MD MPH · contact · Burrish@chop.edu · (215) 573-4916

ContactNiesha Darden · contact · dardenn2@chop.edu

InvestigatorHeather Burris, MD MPH · principal_investigator, University of Pennsylvania

All locations (1)

Hospital of the University of PennsylvaniaRecruiting

Philadelphia, Pennsylvania, United States

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