Postpartum Care in the NICU (PeliCaN) Transitions

NCT06521398 | Recruiting

• 1 other identifier: 855528
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum

  This will measured by the PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The symptom severity score ranges from 0-80 with 80 being a worse score.

  6 months

• Number of participants who have attendance with a primary care provider by 6 months postpartum

  This will be assessed using the electronic health record and via survey and medical record review of outsider records.

  6 months

Secondary Outcomes (2)

• Difference in Depression scores at 6 months postpartum

  6 months

• Receipt of ACOG-recommended postpartum care by patient's designated provider

  12 weeks postpartum

Study Arms (2)

Doula Intervention

EXPERIMENTAL

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.

Other: Doula Support

Control

NO INTERVENTION

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.

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.

Doula Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Premature Birth; Depression, Postpartum

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Depressive Disorder; Mood Disorders

Study Officials

• Heather Burris, MD MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Burris, MD MPH

CONTACT

(215) 573-4916; Burrish@chop.edu

Niesha Darden

CONTACT

dardenn2@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 26, 2024
• Study Start: September 11, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)