Postpartum Care in the NICU (PeliCaN) Transitions

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06521398
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-23
• Study First Posted: 2024-07-26
• Status Verified: 2024-08
• Study Start: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of participants who have attendance with a primary care provider by 6 months postpartum	6 months	This will be assessed using the electronic health record and via survey and medical record review of outsider records.
Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum	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.

Secondary Outcome Measures

Name	Time	Method
Difference in Depression scores at 6 months postpartum	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.
Receipt of ACOG-recommended postpartum care by patient's designated provider	12 weeks postpartum	Comparison between two groups, this will be coded as a Yes or No variable

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States