Postpartum Care in the NICU (PeliCaN) Transitions (PeliCaN)

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.

Study Overview

• Status: Recruiting
• Conditions: Premature Birth; Stress Disorders, Post-Traumatic; Postpartum Depression; Postpartum Anxiety
• Intervention / Treatment: Other: Doula Support

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heather Burris, MD MPH; Phone Number: (215) 573-4916; Email: burrish@chop.edu
• Study Contact Backup: Name: Niesha Darden; Email: dardenn2@chop.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Contact: Heather Burris, MD MPH; Phone Number: (215) 573-4916; Email: burrish@chop.edu
      • Contact: Niesha Darden; Email: dardenn2@chop.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Doula Support; 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in Depression scores at 6 months postpartum	Edinburgh Postnatal Depression Scale, higher scores reflect higher risk of depression, ranges from 0-30. A score of 13 is indicative of high risk for depression.	6 months
Receipt of ACOG-recommended postpartum care by patient's designated provider	Comparison between two groups, this will be coded as a Yes or No variable	12 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Heather Burris, MD MPH, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2024
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: July 18, 2024
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 26, 2024

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Stress Disorders, Traumatic; Depressive Disorder; Premature Birth; Depression, Postpartum; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 855528

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No