Health TrialsbyHealthPanel

Postpartum Care in the NICU (PeliCaN) Transitions

ConditionsStress Disorders, Post-TraumaticPremature BirthPostpartum DepressionPostpartum Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age16+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Doula Support

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Doula InterventionExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
6 months
2

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.

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months
2

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

Time frame
12 weeks postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov
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