Postpartum Care in the NICU (PeliCaN) Transitions

Not Applicable

Not yet recruiting

• Conditions: Premature Birth; Stress Disorders, Post-Traumatic; Postpartum Depression; Postpartum Anxiety
• Interventions: Other: Doula Support

• 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

Arm && Interventions

Group	Intervention	Description
Doula Intervention	Doula Support	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.

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