PostpartumPeliCaNNCT07873190
Postpartum Care in the NICU Multi-Site
A study testing Postpartum Doula Support in the NICU in people with Postpartum and Postpartum Depression (PPD), run by Children's Hospital of Philadelphia at 14 sites in United States.
Trial summary
Parents of infants admitted to the neonatal intensive care unit (NICU) face unique challenges in caring for their own health after giving birth. The demands of having a critically ill infant often make it difficult or impossible to attend postpartum care appointments, and research shows that NICU mothers are… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum, Postpartum Depression (PPD), Hypertension Disorders in Pregnancy
- What is being tested?
- Postpartum Doula Support in the NICU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 756 participants
- Where
- 14 sitesUnited States
- Study dates
- 1 Jan 2027to 30 Jun 2031
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Trial Participant Inclusion Criteria:
- Postpartum individual with an infant currently hospitalized in a participating NICU
- Infant born at less than 34 weeks gestational age, OR infant with a diagnosis associated with a median NICU length of stay of 4 weeks or more (e.g., congenital diaphragmatic hernia, gastroschisis)
- Age 18 years or older at the time of enrollment
- Able to communicate in English or Spanish
- No plans for infant adoption
- No restrictions to visiting their infant(s) in the NICU due to a significant social service issue (e.g., incarceration)
- The clinical team anticipates that their infant, or at least one of their infants if multiples, will remain in the NICU for a minimum of two additional weeks (to avoid anticipated infant palliative care and planned transfers).
Semi-Structured Interview Inclusion Criteria:
- All eligible intervention study participants
- NICU nurses
- Obstetric providers who cared for PeliCaN intervention participants
- English or Spanish as their preferred language
Trial Participant Exclusion Criteria:
- Unable to read or sign informed consent
- If the medical team believes that the infant may die or be transferred to another hospital within 1 week
Semi-Structured Interview Exclusion Criteria:
- None
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United States14 sites
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Heather H Burris, MD, MPH, 267-425-1020, burrish@chop.edu
Katey E Mari, PhD, MPH, marik@chop.edu
Doylestown Hospital
Doylestown, Pennsylvania, 18901
Heather H Burris, MD, MPH, 267-425-1020, burrish@chop.edu
Katey E Mari, PhD, MPH, marik@chop.edu
Children's Hospital of Philadelphia King of Prussia Hospital
King of Prussia, Pennsylvania, 19406
Heather H Burris, MD, MPH, 267-425-1020, burrish@chop.edu
Katey E Mari, PhD, MPH, marik@chop.edu
Lancaster General Health Women & Babies Hospital
Lancaster, Pennsylvania, 17601
Heather H Burris, MD, MPH, 267-425-1020, burrish@chop.edu
Katey E Mari, PhD, MPH, marik@chop.edu
Riddle Hospital
Media, Pennsylvania, 19063
Heather H Burris, MD, MPH, 267-425-1020, burrish@chop.edu
Katey E Mari, PhD, MPH, marik@chop.edu
Christiana Hospital
Newark, Delaware, 19718
Heather H Burris, MD, MPH, 267-425-1020, burrish@chop.edu
Katey E Mari, PhD, MPH, marik@chop.edu
Jefferson Einstein Montgomery Hospital
Norristown, Pennsylvania, 19403
Heather H Burris, MD, MPH, 617-910-7973, burrish@chop.edu
Katey E Mari, PhD, MPH, marik@chop.edu
Paoli Hospital
Paoli, Pennsylvania, 19301
Heather H Burris, MD, MPH, 267-425-1020, burrish@chop.edu
Katey E Mari, PhD, MPH, marik@chop.edu
Lankenau Medical Center
Penn Wynne, Pennsylvania, 19096
Heather H Burris, MD, MPH, 267-425-1020, burrish@chop.edu
Katey E Mari, PhD, MPH, marik@chop.edu
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Heather H Burris, MD, MPH, 267-425-1020, burrish@chop.edu
Katey E Mari, PhD, MPH, 678-943-6941, marik@chop.edu
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Heather H Burris, MD, MPH, 267-425-1020, burrish@chop.edu
Katey E Mari, PhD, MPH, marik@chop.edu
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Heather H Burris, MD, MPH, 267-425-1020, burrish@chop.edu
Katey E Mari, PhD, MPH, 678-943-6941, marik@chop.edu
Virtua Voorhees
Voorhees Township, New Jersey, 08043
Heather H Burris, MD, MPH, 267-425-1020, Burrish@chop.edu
Katey E Mari, PhD, MPH, marik@chop.edu
Chester County Hospital
West Chester, Pennsylvania, 19380
Heather H Burris, MD, MPH, 267-425-1020, burrish@chop.edu
Katey E Mari, PhD, MPH, marik@chop.edu
About this study
Official title: Postpartum Care in the NICU (PeliCaN), a Cluster Randomized Controlled Trial of Doula Support and Healthcare Navigation
Parents of infants admitted to the neonatal intensive care unit (NICU) face unique challenges in caring for their own health after giving birth. The demands of having a critically ill infant often make it difficult or impossible to attend postpartum care appointments, and research shows that NICU mothers are significantly more likely than other new mothers to develop postpartum depression and other health conditions, including hypertensive disorders of pregnancy. However, these conditions frequently go undetected and untreated because standard postpartum care systems are not designed to address the needs of NICU mothers, who often prioritize being present in the NICU over their own needs.
The PeliCaN (Postpartum Care in the NICU) Multi-Site trial will test whether trained postpartum doulas supporting mothers directly in the NICU can help close postpartum care gaps. Study doulas will provide emotional support, help mothers monitor their blood pressure, screen for postpartum depression, assist with scheduling and attending postpartum care visits, and connect families to community resources while their infant is in the NICU and after discharge for up to 6 months.
Read more
The study team will enroll approximately 756 mothers across 13 NICUs in the Metro-Philadelphia area. Participating NICUs will be randomly assigned to groups on a stepped-wedge schedule to begin offering the doula intervention. Mothers enrolled before their site begins the doula intervention will receive standard postpartum care and support; mothers enrolled after their site transitions to the intervention period will receive doula support. All participants will complete surveys at enrollment and at 6 months after birth and will have their medical records reviewed.
The study's main goals are to determine whether having a doula in the NICU helps mothers to receive recommended comprehensive postpartum care within the first 12 weeks after birth and will assess whether doula support reduces symptoms of postpartum depression and increases maternal transition to primary adult care by 6 months postpartum. The study will also examine the experience of implementing doulas in the NICU across multiple hospital sites among intervention participants and NICU staff members.
Read the detailed description
Background:
Approximately 10-15% of all births in the United States result in neonatal intensive care unit (NICU) admission annually. Parents of NICU infants face a multitude of stressors that place them at elevated risk for postpartum morbidities and mortality. For example, NICU mothers are 3 to 4 times more likely to develop postpartum depression (PPD) than mothers of well infants, and nearly 3 times more likely to experience hypertensive disorders of pregnancy (HDP), including postpartum preeclampsia, a leading cause of maternal mortality in the United States. The demands of having an infant in the NICU mean that these same mothers are among the least likely to receive timely, comprehensive postpartum care. Evidence shows that NICU mothers attend postpartum visits at substantially lower rates than the general obstetric population, missing the primary opportunity for depression screening, blood pressure monitoring, and connection to ongoing care.
Intervention:
The PeliCaN intervention is a structured postpartum doula support program embedded directly in the NICU. Trained, NICU-informed postpartum doulas will support mothers during the study intervention period in each participating NICU. Doula support will begin within 3 days of enrollment (target: within 10 days of birth) and will continue for 6 months postpartum. During the infant's NICU hospitalization, doula contact will take place in-person at the bedside as well as virtually via phone, text, and video connections. Following infant discharge, support will continue virtually for up to 6 months.
The PeliCaN doula intervention includes: (1) emotional and informational support throughout the NICU stay and transition home; (2) postpartum depression screening using the Edinburgh Postnatal Depression Scale (EPDS) at 1, 2, and 4 months postpartum, with standardized escalation to NICU social workers and obstetric clinicians for any score ≥10 or positive response to Item #10 (suicidal ideation); (3) blood pressure monitoring facilitation in the NICU using validated home BP monitors, with a structured escalation protocol for readings meeting established hypertensive thresholds; and (4) postpartum healthcare coordination, including assistance scheduling and attending postpartum visits, navigating transition to primary care as well as coordinating referrals and visits with cardiology and mental health providers as needed.
Study doulas do not provide clinical care and do not replace any member of the mothers' obstetric clinical team. Rather, doulas serve as a sustained, trusted support person for the mother's own health during a period when maternal needs are routinely deprioritized.
Study Design:
PeliCaN Multi-Site is a type-1 hybrid, effectiveness-implementation stepped-wedge cluster randomized controlled trial. Thirteen NICUs within the Children's Hospital of Philadelphia (CHOP) Newborn Care Network will be randomized into clustered groups of four (two NICUs will be co-randomized). All sites begin in the usual care (control) condition and cross over to the intervention condition at pre-set time points across the study period, such that by the end of the trial all sites will have offered the doula intervention. This design controls for secular trends and allows for within-site pre-post comparisons in addition to between-arm comparisons.
The study is adequately powered, and funded, to enroll approximately 765 participants (378 intervention / 378 usual care) across all sites but are approved to enroll up to 900 participants. Eligible participants are postpartum individuals aged 18 or older with an infant currently hospitalized in a participating NICU, who gave birth at less than 34 weeks gestational age or whose infant has a diagnosis associated with a NICU length of stay of 4 or more weeks, and who are able to communicate in English or Spanish. Participants will be enrolled within 14 days of birth.
Aims:
Aim 1 (Primary Effectiveness): To determine the effectiveness of PeliCaN doula support vs usual care to improve receipt of recommended postpartum healthcare, i.e., (a) screening for depression (EPDS) and (b) screening and management of hypertension (BP) during an infant's NICU hospitalization, as well as (c) attendance at a postpartum visit within 12 weeks.
Aim 2 (Secondary Effectiveness): At 6 months postpartum, to examine effectiveness of PeliCaN vs usual care to (a) decrease depression symptoms and (b) increase transition to primary care clinician or cardiologist for long-term BP management among mothers with hypertensive disorders diagnosed during pregnancy.
Aim 3 (Implementation): To examine the feasibility; (b) acceptability; and (c) fidelity of PeliCaN through mixed methods aimed at understanding perspectives of several key parties (mothers, doulas, NICU staff, and postpartum healthcare clinicians).
Data Collection:
All participants complete a baseline survey at enrollment and a 6-month follow-up survey. Surveys will assess health-related quality of life, social support, healthcare utilization, and demographic and socioeconomic information. Electronic health record data will be abstracted for all participants to confirm postpartum visit attendance and ascertain key covariates including, obstetric diagnoses, medication prescriptions, postpartum care utilization, and infant health information. Doula tracking logs will capture all doula encounters, postpartum depression screening, blood pressure readings, and escalation actions for intervention participants.
Safety Monitoring:
An independent Data Safety Monitoring Board (DSMB) composed of experts in maternal-fetal medicine, perinatal mental health, and biostatistics will review study safety data at biannual meetings. The DSMB will operate under a formal charter and has authority to recommend study modification or early termination if safety concerns arise. The study team will maintain a structured safety monitoring plan with defined escalation procedures for positive EPDS screens and hypertensive emergencies, site-specific clinical escalation contacts, and standardized adverse event reporting to the Institutional Review Board (IRB) and NIH.
- Conditions
- Postpartum, Postpartum Depression (PPD), Hypertension Disorders in Pregnancy, Postpartum Anxiety, Postpartum Care, Care Coordination
- Being tested
- Postpartum Doula Support in the NICU
- Keywords
- Postpartum Care, Doula, NICU, Postpartum depression, Postpartum health, Postpartum doula, Healthcare navigation
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum Doula Support in the NICUBehavioural
Participants enrolled when sites are active in the intervention period will receive support from a trained postpartum doula embedded in the NICU. Doulas provide in-person emotional support and psychosocial assistance, facilitate maternal blood pressure monitoring and escalation of abnormal readings to obstetric providers, administer the Edinburgh Postnatal Depression Scale (EPDS) at 1, 2, and 4 months postpartum and escalate positive screens to the clinical team, coordinate postpartum healthcare including scheduling and attendance at the postpartum visit, and support care transitions to primary care and cardiology as needed. Doula contact will begin within 3 days of enrollment and continues for 6 months postpartum, with in-person visits and virtual support during the NICU hospitalization and virtual-only support after infant discharge.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Doula Support) | Experimental | NICU sites during their intervention period. Enrolled participants receive postpartum doula support beginning within 3 days of enrollment and continuing for 6 months postpartum. Receives: Behavioral: Postpartum Doula Support in the NICU |
| Usual Care (Control) | No intervention | NICU sites during their control period. Enrolled participants receive standard clinical care without study doula support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receipt of Comprehensive Postpartum Care (Composite)
The primary outcome is the number of subjects who meet the following definition of positive comprehensive postpartum care receipt assessed across three Yes/No components. All three must be "Yes" for a participant to receive a composite score indicating comprehensive postpartum care was received.
- Depression screening (EPDS or equivalent) completed at 1, 2, and 4 months postpartum at all timepoints during which the infant remains hospitalized in the NICU.
- For mothers without HDP: blood pressure check completed within 3-10 days postpartum AND at the standard postpartum visit (4-8 weeks) or for mothers with HDP: adherence to blood pressure monitoring, antihypertensive medication receipt, and follow-up per maternal discharge instructions for the duration of the NICU stay.
- Attendance at a comprehensive postpartum visit with an obstetric provider within 84 days (12 weeks) of birth, confirmed by electronic health record abstraction and self-report.
Measured: From birth through 12 weeks postpartum
Secondary outcomes (6)
Secondary Effectiveness Outcome - Long-Term Hypertension Management
Transition to ongoing cardiovascular care (mothers with HDP only): Whether the participant has been connected to an adult primary care provider or cardiologist for ongoing blood pressure management by 6 months postpartum, ascertained by self-report on the 6-month follow-up survey and confirmed by EHR abstraction. Participants will receive a Yes/No score, where "Yes" will indicate that they either attended a healthcare visit with their primary care provider or with a cardiologist by the six-month visit for ongoing hypertension management.
Measured: From birth through six months postpartum
Secondary Effectiveness Outcome - Depression Symptoms Score
The secondary effectiveness outcome assesses the impact of the PeliCaN doula intervention on longer-term maternal depression symptoms at 6 months.
Clinically significant depressive symptoms at 6 months postpartum, measured using the PROMIS Depression 8-item short form administered on the 6-month follow-up survey. The PROMIS Depression short form is a patient-reported measure of depressive symptoms over the past 7 days, each item rated on a 5-point Likert scale (raw score range 8-40) and summed, with raw scores converted to standardized T-scores (range 38.2-81.3) where higher scores indicate greater depression severity.
Measured: From birth through six months postpartum
Feasibility - Feasibility of Intervention Measure (FIM)
Feasibility will be quantitively assessed via stakeholder perceptions of intervention suitability for everyday use in the NICU, measured using the Feasibility of Intervention Measure (FIM), a validated 4-item self-report scale scored on a 5-point Likert scale (mean score range 1-5; higher scores indicate greater perceived feasibility), administered via structured survey to doulas, NICU nurses, and obstetric clinicians at each participating site. Results will be complimented by semi-structured qualitative interviews with a purposive sample of participants, doulas, and site clinical leaders.
Measured: Birth to end of study, approximately 3 years
Feasibility - Average Enrollment
Feasibility will be assessed by measuring the average time spent by each doula per enrolled mother per week, in minutes, derived from the Doula Tracking Log across the 6-month intervention period. Doula time spent with participants will be examined by site and by respondent role.
Measured: From birth to end of study, approximately 3 years
Acceptability of the PeliCaN Doula Intervention (AIM)
Acceptability assessed using the Acceptability of Intervention Measure (AIM), a validated 4-item self-report scale measuring stakeholder perceptions that the content of the PeliCaN doula intervention is satisfactory, scored on a 5-point Likert scale (mean score range 1-5; higher scores indicate greater acceptability). Administered via structured survey to doulas, NICU nurses, and obstetric clinicians at each participating site. Results examined by site, respondent role, and intervention period and will be complimented by semi-structured qualitative interviews with a purposive sample of participants, doulas, and site clinical leaders.
Measured: End of study, approximately 3 years
Fidelity of PeliCaN Doula Intervention Delivery
Intervention fidelity measured as the average percentage of completed weekly doula contacts among all enrolled intervention participants across the 6-month intervention period. A weekly contact is defined as any documented in-person, phone, or video encounter between the doula and the participant logged in the REDCap Doula Tracking Log. The fidelity metric is calculated per doula and per site as the proportion of expected weekly contacts that were completed, averaged across all enrolled participants and all weeks of the intervention period. Secondary fidelity indicators include the proportion of participants who received EPDS screening at each protocol-specified timepoint and the proportion who received blood pressure monitoring facilitation at designated timepoints.
Measured: 6 months through end of study, approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion30 Mar 2030 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a stepped-wedge cluster randomized controlled trial design. Thirteen NICU sites (two co-located NICUs will be co-randomized) within the CHOP Newborn Care Network are randomized to cross from the control condition (usual care) to the intervention condition (postpartum doula support) at staggered time points across the study period. All sites begin in the usual care condition and sequentially cross over to the intervention condition according to a pre-determined randomized schedule. This design ensures that all sites ultimately receive the intervention while allowing for temporal control and within-site comparisons.
- Masking
- None (open label)
- Enrolment
- 756 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Main Line Health, Thomas Jefferson Health, Virtua Health
- Responsible party
- Sponsor
- Investigators
- Heather H Burris, MD, MPH, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873190
- Sponsor's protocol ID
- 26-024489
- Other IDs
- R01HD121939-01
- Acronym
- PeliCaN
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying results reported in primary publications will be shared. Data will be deposited in the NICHD Data and Specimen Hub (DASH) or an equivalent NIH-approved repository no later than the time of primary publication or within 12 months of the primary completion date, whichever comes first.
Publications
Burris HH, Darden N, Power M, Walker L, Ledyard R, Reiter J, Lewey J, Trout KK, Tan M, Gregory EF, DeMauro SB, Lorch SA, Christ L, Handley SC, Montoya-Williams D, Durnwald C. Postpartum care in the neonatal intensive care unit, PeliCaN: a randomized controlled trial. Am J Obstet Gynecol MFM. 2025 Jul;7(7):101689. doi: 10.1016/j.ajogmf.2025.101689. Epub 2025 Jun 16.
PubMed 40334984Baumann LJ, Darden N, Ledyard R, Parker MG, Power ME, Walker L, Durnwald CP, Burris HH. Breastfeeding Continuation at 6 Months among Mother-Infant Dyads Participating in the Postpartum Care in the NICU (PeliCaN) Pilot Trial. J Perinatol. 2026 Apr;46(4):646-648. doi: 10.1038/s41372-026-02616-x. Epub 2026 Mar 6. No abstract available.
PubMed 41792421Scott K, Miller E, Culhane JF, Greenspan J, Handley SC, Lo JY, Knake LA, McKenney KM, Nelin TD, Gregory EF, Dysart K, Burris HH. Length of gestation and postpartum visit attendance. Pregnancy (Hoboken). 2026 May;2(3):e70306. doi: 10.1002/pmf2.70306. Epub 2026 May 13.
PubMed 42282853Mari KE, Hoke MK, Darden N, Burris HH. Postpartum care receipt among parents of infants admitted to a freestanding children's hospital neonatal intensive care unit (NICU). J Perinatol. 2026 Mar;46(3):460-466. doi: 10.1038/s41372-025-02476-x. Epub 2025 Nov 17.
PubMed 41249594Scott K, Ledyard RF, Darden N, Durnwald C, Handley SC, Nelin TD, Power M, Sinclair TR, Burris HH. Postpartum care receipt among parents of preterm infants admitted to the neonatal intensive care unit. Am J Obstet Gynecol MFM. 2025 May;7(5):101659. doi: 10.1016/j.ajogmf.2025.101659. Epub 2025 Mar 1. No abstract available.
PubMed 40032179Tan MT, Darden N, Peterson K, Trout KK, Christ L, Handley SC, Kornfield SL, Power ME, Montoya-Williams D, Lewey J, Gregory EF, Lorch SA, DeMauro SB, Levine LD, Burris HH. Bringing postpartum care to the NICU-An opportunity to improve health in a high-risk obstetric population. J Perinatol. 2023 Jan;43(1):1-2. doi: 10.1038/s41372-022-01525-z. Epub 2022 Oct 5. No abstract available.
PubMed 36198771Corson CL, Martin AE, Darden N, Walker L, Power ME, Durnwald CP, Handley SC, Burris HH. Facilitating Postpartum Care with a Doula and Certified Nurse Midwife in the Neonatal Intensive Care Unit: A Qualitative Analysis of Maternal Experiences. Pregnancy (Hoboken). 2025 Nov;1(6):e70179. doi: 10.1002/pmf2.70179. Epub 2025 Nov 14.
PubMed 41536527
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Care in the NICU (PeliCaN), a Cluster Randomized Controlled Trial of Doula Support and Healthcare Navigation
- ClinicalTrials.gov ID
- NCT07873190
- Acronym / sponsor ID
- PeliCaN / 26-024489
- Conditions
- Postpartum, Postpartum Depression (PPD), Hypertension Disorders in Pregnancy, Postpartum Anxiety, Postpartum Care, Care Coordination
- Keywords
- Postpartum Care, Doula, NICU, Postpartum depression, Postpartum health, Postpartum doula, Healthcare navigation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 756 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Main Line Health, Thomas Jefferson Health, Virtua Health
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Mar 2030 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 14 Oct 2026 (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.
Parents of infants admitted to the neonatal intensive care unit (NICU) face unique challenges in caring for their own health after giving birth. The demands of having a critically ill infant often make it difficult or impossible to attend postpartum care appointments, and research shows that NICU mothers are significantly more likely than other new mothers to develop postpartum depression and other health conditions, including hypertensive disorders of pregnancy. However, these conditions frequently go undetected and untreated because standard postpartum care systems are not designed to address the needs of NICU mothers, who often prioritize being present in the NICU over their own needs.
The PeliCaN (Postpartum Care in the NICU) Multi-Site trial will test whether trained postpartum doulas supporting mothers directly in the NICU can help close postpartum care gaps. Study doulas will provide emotional support, help mothers monitor their blood pressure, screen for postpartum depression, assist with scheduling and attending postpartum care visits, and connect families to community resources while their infant is in the NICU and after discharge for up to 6 months.
The study team will enroll approximately 756 mothers across 13 NICUs in the Metro-Philadelphia area. Participating NICUs will be randomly assigned to groups on a stepped-wedge schedule to begin offering the doula intervention. Mothers enrolled before their site begins the doula intervention will receive standard postpartum care and support; mothers enrolled after their site transitions to the intervention period will receive doula support. All participants will complete surveys at enrollment and at 6 months after birth and will have their medical records reviewed.
The study's main goals are to determine whether having a doula in the NICU helps mothers to receive recommended comprehensive postpartum care within the first 12 weeks after birth and will assess whether doula support reduces symptoms of postpartum depression and increases maternal transition to primary adult care by 6 months postpartum. The study will also examine the experience of implementing doulas in the NICU across multiple hospital sites among intervention participants and NICU staff members.
Detailed description
Background:
Approximately 10-15% of all births in the United States result in neonatal intensive care unit (NICU) admission annually. Parents of NICU infants face a multitude of stressors that place them at elevated risk for postpartum morbidities and mortality. For example, NICU mothers are 3 to 4 times more likely to develop postpartum depression (PPD) than mothers of well infants, and nearly 3 times more likely to experience hypertensive disorders of pregnancy (HDP), including postpartum preeclampsia, a leading cause of maternal mortality in the United States. The demands of having an infant in the NICU mean that these same mothers are among the least likely to receive timely, comprehensive postpartum care. Evidence shows that NICU mothers attend postpartum visits at substantially lower rates than the general obstetric population, missing the primary opportunity for depression screening, blood pressure monitoring, and connection to ongoing care.
Intervention:
The PeliCaN intervention is a structured postpartum doula support program embedded directly in the NICU. Trained, NICU-informed postpartum doulas will support mothers during the study intervention period in each participating NICU. Doula support will begin within 3 days of enrollment (target: within 10 days of birth) and will continue for 6 months postpartum. During the infant's NICU hospitalization, doula contact will take place in-person at the bedside as well as virtually via phone, text, and video connections. Following infant discharge, support will continue virtually for up to 6 months.
The PeliCaN doula intervention includes: (1) emotional and informational support throughout the NICU stay and transition home; (2) postpartum depression screening using the Edinburgh Postnatal Depression Scale (EPDS) at 1, 2, and 4 months postpartum, with standardized escalation to NICU social workers and obstetric clinicians for any score ≥10 or positive response to Item #10 (suicidal ideation); (3) blood pressure monitoring facilitation in the NICU using validated home BP monitors, with a structured escalation protocol for readings meeting established hypertensive thresholds; and (4) postpartum healthcare coordination, including assistance scheduling and attending postpartum visits, navigating transition to primary care as well as coordinating referrals and visits with cardiology and mental health providers as needed.
Study doulas do not provide clinical care and do not replace any member of the mothers' obstetric clinical team. Rather, doulas serve as a sustained, trusted support person for the mother's own health during a period when maternal needs are routinely deprioritized.
Study Design:
PeliCaN Multi-Site is a type-1 hybrid, effectiveness-implementation stepped-wedge cluster randomized controlled trial. Thirteen NICUs within the Children's Hospital of Philadelphia (CHOP) Newborn Care Network will be randomized into clustered groups of four (two NICUs will be co-randomized). All sites begin in the usual care (control) condition and cross over to the intervention condition at pre-set time points across the study period, such that by the end of the trial all sites will have offered the doula intervention. This design controls for secular trends and allows for within-site pre-post comparisons in addition to between-arm comparisons.
The study is adequately powered, and funded, to enroll approximately 765 participants (378 intervention / 378 usual care) across all sites but are approved to enroll up to 900 participants. Eligible participants are postpartum individuals aged 18 or older with an infant currently hospitalized in a participating NICU, who gave birth at less than 34 weeks gestational age or whose infant has a diagnosis associated with a NICU length of stay of 4 or more weeks, and who are able to communicate in English or Spanish. Participants will be enrolled within 14 days of birth.
Aims:
Aim 1 (Primary Effectiveness): To determine the effectiveness of PeliCaN doula support vs usual care to improve receipt of recommended postpartum healthcare, i.e., (a) screening for depression (EPDS) and (b) screening and management of hypertension (BP) during an infant's NICU hospitalization, as well as (c) attendance at a postpartum visit within 12 weeks.
Aim 2 (Secondary Effectiveness): At 6 months postpartum, to examine effectiveness of PeliCaN vs usual care to (a) decrease depression symptoms and (b) increase transition to primary care clinician or cardiologist for long-term BP management among mothers with hypertensive disorders diagnosed during pregnancy.
Aim 3 (Implementation): To examine the feasibility; (b) acceptability; and (c) fidelity of PeliCaN through mixed methods aimed at understanding perspectives of several key parties (mothers, doulas, NICU staff, and postpartum healthcare clinicians).
Data Collection:
All participants complete a baseline survey at enrollment and a 6-month follow-up survey. Surveys will assess health-related quality of life, social support, healthcare utilization, and demographic and socioeconomic information. Electronic health record data will be abstracted for all participants to confirm postpartum visit attendance and ascertain key covariates including, obstetric diagnoses, medication prescriptions, postpartum care utilization, and infant health information. Doula tracking logs will capture all doula encounters, postpartum depression screening, blood pressure readings, and escalation actions for intervention participants.
Safety Monitoring:
An independent Data Safety Monitoring Board (DSMB) composed of experts in maternal-fetal medicine, perinatal mental health, and biostatistics will review study safety data at biannual meetings. The DSMB will operate under a formal charter and has authority to recommend study modification or early termination if safety concerns arise. The study team will maintain a structured safety monitoring plan with defined escalation procedures for positive EPDS screens and hypertensive emergencies, site-specific clinical escalation contacts, and standardized adverse event reporting to the Institutional Review Board (IRB) and NIH.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a stepped-wedge cluster randomized controlled trial design. Thirteen NICU sites (two co-located NICUs will be co-randomized) within the CHOP Newborn Care Network are randomized to cross from the control condition (usual care) to the intervention condition (postpartum doula support) at staggered time points across the study period. All sites begin in the usual care condition and sequentially cross over to the intervention condition according to a pre-determined randomized schedule. This design ensures that all sites ultimately receive the intervention while allowing for temporal control and within-site comparisons.
| Arm | Type | Receives |
|---|---|---|
| Intervention (Doula Support) | Experimental | Behavioral: Postpartum Doula Support in the NICUNICU sites during their intervention period. Enrolled participants receive postpartum doula support beginning within 3 days of enrollment and continuing for 6 months postpartum. |
| Usual Care (Control) | No intervention | –NICU sites during their control period. Enrolled participants receive standard clinical care without study doula support. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Postpartum Doula Support in the NICUParticipants enrolled when sites are active in the intervention period will receive support from a trained postpartum doula embedded in the NICU. Doulas provide in-person emotional support and psychosocial assistance, facilitate maternal blood pressure monitoring and escalation of abnormal readings to obstetric providers, administer the Edinburgh Postnatal Depression Scale (EPDS) at 1, 2, and 4 months postpartum and escalate positive screens to the clinical team, coordinate postpartum healthcare including scheduling and attendance at the postpartum visit, and support care transitions to primary care and cardiology as needed. Doula contact will begin within 3 days of enrollment and continues for 6 months postpartum, with in-person visits and virtual support during the NICU hospitalization and virtual-only support after infant discharge. | Behavioural | Intervention (Doula Support) |
Primary outcome
Receipt of Comprehensive Postpartum Care (Composite)
Time frame: From birth through 12 weeks postpartum
The primary outcome is the number of subjects who meet the following definition of positive comprehensive postpartum care receipt assessed across three Yes/No components. All three must be "Yes" for a participant to receive a composite score indicating comprehensive postpartum care was received. 1. Depression screening (EPDS or equivalent) completed at 1, 2, and 4 months postpartum at all timepoints during which the infant remains hospitalized in the NICU. 2. For mothers without HDP: blood pressure check completed within 3-10 days postpartum AND at the standard postpartum visit (4-8 weeks) or for mothers with HDP: adherence to blood pressure monitoring, antihypertensive medication receipt, and follow-up per maternal discharge instructions for the duration of the NICU stay. 3. Attendance at a comprehensive postpartum visit with an obstetric provider within 84 days (12 weeks) of birth, confirmed by electronic health record abstraction and self-report.
6 secondary outcomes
Secondary Effectiveness Outcome - Long-Term Hypertension Management
Time frame: From birth through six months postpartum
Secondary Effectiveness Outcome - Depression Symptoms Score
Time frame: From birth through six months postpartum
Feasibility - Feasibility of Intervention Measure (FIM)
Time frame: Birth to end of study, approximately 3 years
Feasibility - Average Enrollment
Time frame: From birth to end of study, approximately 3 years
Acceptability of the PeliCaN Doula Intervention (AIM)
Time frame: End of study, approximately 3 years
Fidelity of PeliCaN Doula Intervention Delivery
Time frame: 6 months through end of study, approximately 5 years
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 2026.
- Background: PubMed 40334984Burris HH, Darden N, Power M, Walker L, Ledyard R, Reiter J, Lewey J, Trout KK, Tan M, Gregory EF, DeMauro SB, Lorch SA, Christ L, Handley SC, Montoya-Williams D, Durnwald C. Postpartum care in the neonatal intensive care unit, PeliCaN: a randomized controlled trial. Am J Obstet Gynecol MFM. 2025 Jul;7(7):101689. doi: 10.1016/j.ajogmf.2025.101689. Epub 2025 Jun 16.
- Background: PubMed 41792421Baumann LJ, Darden N, Ledyard R, Parker MG, Power ME, Walker L, Durnwald CP, Burris HH. Breastfeeding Continuation at 6 Months among Mother-Infant Dyads Participating in the Postpartum Care in the NICU (PeliCaN) Pilot Trial. J Perinatol. 2026 Apr;46(4):646-648. doi: 10.1038/s41372-026-02616-x. Epub 2026 Mar 6. No abstract available.
- Background: PubMed 42282853Scott K, Miller E, Culhane JF, Greenspan J, Handley SC, Lo JY, Knake LA, McKenney KM, Nelin TD, Gregory EF, Dysart K, Burris HH. Length of gestation and postpartum visit attendance. Pregnancy (Hoboken). 2026 May;2(3):e70306. doi: 10.1002/pmf2.70306. Epub 2026 May 13.
- Background: PubMed 41249594Mari KE, Hoke MK, Darden N, Burris HH. Postpartum care receipt among parents of infants admitted to a freestanding children's hospital neonatal intensive care unit (NICU). J Perinatol. 2026 Mar;46(3):460-466. doi: 10.1038/s41372-025-02476-x. Epub 2025 Nov 17.
- Background: PubMed 40032179Scott K, Ledyard RF, Darden N, Durnwald C, Handley SC, Nelin TD, Power M, Sinclair TR, Burris HH. Postpartum care receipt among parents of preterm infants admitted to the neonatal intensive care unit. Am J Obstet Gynecol MFM. 2025 May;7(5):101659. doi: 10.1016/j.ajogmf.2025.101659. Epub 2025 Mar 1. No abstract available.
- Background: PubMed 36198771Tan MT, Darden N, Peterson K, Trout KK, Christ L, Handley SC, Kornfield SL, Power ME, Montoya-Williams D, Lewey J, Gregory EF, Lorch SA, DeMauro SB, Levine LD, Burris HH. Bringing postpartum care to the NICU-An opportunity to improve health in a high-risk obstetric population. J Perinatol. 2023 Jan;43(1):1-2. doi: 10.1038/s41372-022-01525-z. Epub 2022 Oct 5. No abstract available.
- Background: PubMed 41536527Corson CL, Martin AE, Darden N, Walker L, Power ME, Durnwald CP, Handley SC, Burris HH. Facilitating Postpartum Care with a Doula and Certified Nurse Midwife in the Neonatal Intensive Care Unit: A Qualitative Analysis of Maternal Experiences. Pregnancy (Hoboken). 2025 Nov;1(6):e70179. doi: 10.1002/pmf2.70179. Epub 2025 Nov 14.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying results reported in primary publications will be shared. Data will be deposited in the NICHD Data and Specimen Hub (DASH) or an equivalent NIH-approved repository no later than the time of primary publication or within 12 months of the primary completion date, whichever comes first.
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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.
Heather H Burris, MD, MPH principal investigator
Children's Hospital of Philadelphia
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postpartum Doula Support in the NICU in people with Postpartum and Postpartum Depression (PPD), run by Children's Hospital of Philadelphia at 14 sites 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?
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: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 H Burris, MD, MPH (267-425-1020, Burrish@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Receipt of Comprehensive Postpartum Care (Composite) (time frame: From birth through 12 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07873190, which also lists 7 linked publications.
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 2026.