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Postpartum Care in the NICU Multi-Site

Postpartum Care in the NICU (PeliCaN), a Cluster Randomized Controlled Trial of Doula Support and Healthcare Navigation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "All participants will complete surveys at enrollment and at 6 months after birth and will have their medical records reviewed."
  • "Doula support will begin within 3 days of enrollment (target: within 10 days of birth) and will continue for 6 months postpartum."
  • "Following infant discharge, support will continue virtually for up to 6 months."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether doulas, trained workers who support people after birth, help mothers get health care and reduce signs of depression after birth. It is for people whose babies are in a participating neonatal intensive care unit (NICU), a hospital unit for babies who need special care. Doula support lasts up to 6 months after birth.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You gave birth and have a baby in a participating NICU.
  • Your baby was born before 34 weeks of pregnancy, or has a condition that usually means a NICU stay of 4 weeks or longer.
  • You are at least 18 years old when you join.
  • You can communicate in English or Spanish.
  • You do not plan to place your baby for adoption.
  • You have no limits on visiting your baby because of a major social service issue, such as being in jail.
  • The care team expects your baby to stay in the NICU for at least 2 more weeks. If you have more than one baby, at least one must meet this rule.
  • For interviews: eligible study participants who receive doula support, NICU nurses, and pregnancy-care providers who cared for these participants may join. Their preferred language must be English or Spanish.

Who can't join

  • You cannot read or sign the form agreeing to take part in the study.
  • The medical team thinks your baby may die or move to another hospital within 1 week.
  • There are no exclusion rules for the interviews.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (14)

DE

NJ

PA