Stress Disorders, Post-TraumaticPeliCaNNCT06521398
Postpartum Care in the NICU (PeliCaN) Transitions
A study testing Doula Support in people with Stress Disorders, Post-Traumatic and Premature Birth, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Premature Birth, Postpartum Depression
- What is being tested?
- Doula Support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Niesha Darden contact
United States1 site, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Heather Burris, MD MPH, (215) 573-4916, burrish@chop.edu
Niesha Darden, dardenn2@chop.edu
About this study
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.
- Conditions
- Stress Disorders, Post-Traumatic, Premature Birth, Postpartum Depression, Postpartum Anxiety
- Being tested
- Doula Support
- Medical subject headings
- Stress Disorders, Post-Traumatic, Premature Birth, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doula SupportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Doula Intervention | Experimental | 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. Receives: Other: Doula Support |
| Control | No intervention | Participants randomized to usual care will get the same care they normally would with their own provider, outside of research enrollment, and receive a resource guide with information about the importance of postpartum follow-up care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
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.
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
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
Measured: 12 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start11 Sep 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heather Burris, University of Pennsylvania
- Investigators
- Heather Burris, MD MPH, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521398
- Sponsor's protocol ID
- 855528
- Acronym
- PeliCaN
- Status last verified
- Oct 2025
- First submitted
- 18 Jul 2024
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Care in the NICU (PeliCaN) Transitions
- ClinicalTrials.gov ID
- NCT06521398
- Acronym / sponsor ID
- PeliCaN / 855528
- Conditions
- Stress Disorders, Post-Traumatic, Premature Birth, Postpartum Depression, Postpartum Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 26 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doula Intervention | Experimental | Other: Doula SupportParticipants 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. |
| Control | No intervention | –Participants randomized to usual care will get the same care they normally would with their own provider, outside of research enrollment, and receive a resource guide with information about the importance of postpartum follow-up care. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doula SupportDoula 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. | Other | Doula Intervention |
Primary outcome
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.
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Niesha Darden contact
Heather Burris, MD MPH principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doula Support in people with Stress Disorders, Post-Traumatic and Premature Birth, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Burris, MD MPH ((215) 573-4916, Burrish@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Post Traumatic Stress Disorder Scores at 6 months postpartum (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025; AzTrials last refreshed its copy on 6 Nov 2026.