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.
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
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
Crossover
Postpartum Doula Support in the NICU
BehavioralParticipants 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.
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. 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.
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.
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.
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.
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.
Receipt of Mental Health Services When Desired and Recommended
Binary (Yes/No) indicator of whether the participant received mental health services (therapy, psychiatry) when such treatment was either desired by the participant or recommended by their healthcare professional during the study period. Ascertained by self-report on the 6-month follow-up survey. This measure captures whether the doula intervention facilitates follow-through on mental health referrals rather than referral alone.
Infant NICU Length of Stay
Continuous measure of the total number of days the infant was hospitalized in the NICU from birth to discharge, transfer, or death. Ascertained by electronic health record abstraction from infant electronic medical record review. Examined as a secondary outcome to assess whether doula-facilitated maternal care coordination influences the clinical trajectory of the NICU hospitalization.
Maternal Urgent Care, Emergency Department, and Hospitalization Visits
Count and type of maternal urgent care visits, emergency department visits, and unplanned hospitalizations occurring in the postpartum period through 6 months. Ascertained by participant self-report on the 6-month follow-up survey and confirmed by electronic health record abstraction. Outcomes examined include any utilization (Yes/No), total number of visits, and visit type. Postpartum hypertensive emergencies and psychiatric crises will be captured within this measure.
Generalized Anxiety Disorder Symptoms (GAD-7)
Anxiety symptom severity assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7), a validated self-report measure scored 0-21. Scores of 5, 10, and 15 represent mild, moderate, and severe anxiety thresholds, respectively. Administered on the 6-month follow-up surveys. Both continuous total scores and the proportion of participants meeting threshold for moderate-to-severe anxiety (GAD-7 ≥10) will be examined.
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Children's Hospital of Philadelphia
Lead sponsor
University of Pennsylvania
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Main Line Health
Collaborator
Thomas Jefferson Health
Collaborator
Virtua Health
Collaborator
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