Postpartum Care in the NICU Multi-Site

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.