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NCT Number: NCT06521398

Postpartum Care in the NICU (PeliCaN) Transitions

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.

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Key information

Conditions

Stress Disorders, Post-Traumatic Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Obstetric Labor Complications Obstetric Labor, Premature Postpartum Anxiety Postpartum Depression Pregnancy Complications Premature Birth Puerperal Disorders Stress Disorders, Traumatic Trauma and Stressor Related Disorders Urogenital Diseases

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum

    Time frame: 6 months

    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.

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

    Time frame: 6 months

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

Secondary outcomes

  1. Difference in Depression scores at 6 months postpartum

    Time frame: 6 months

    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.

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

    Time frame: 12 weeks postpartum

    Comparison between two groups, this will be coded as a Yes or No variable

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Burris, MD MPH

CONTACT

[email protected]

(215) 573-4916

Niesha Darden

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Acronym: PeliCaN

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 26, 2024
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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