Postpartum Care in the NICU (PeliCaN) Transitions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Doula Support.
- Who it may be relevant to
- Registry conditions: Stress Disorders, Post-Traumatic, Premature Birth, Postpartum Depression, Postpartum Anxiety. Basic parameters: from 16 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum [Time frame: 6 months]
- Number of participants who have attendance with a primary care provider by 6 months postpartum [Time frame: 6 months]
Secondary outcome measures (2)
- Difference in Depression scores at 6 months postpartum [Time frame: 6 months]
- Receipt of ACOG-recommended postpartum care by patient's designated provider [Time frame: 12 weeks postpartum]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Hospital of the University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT06521398 · 855528