Doula support for mothers of babies in the neonatal intensive care unit

Trial details

Who runs it

Children's Hospital of Philadelphia

Trial code

NCT07873190

Record updated

14 October 2026

Original description

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.Read full original descriptionShow less

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.

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.

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.

ClinicalTrials.gov NCT07873190