Doula Support for Breastfeeding
(PeliCaN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Parents of infants in the neonatal intensive care unit (NICU) face unique barriers to long-term breastfeeding and lactation. The physical and emotional demands of having a critically ill or premature newborn combined with the stress, sleep deprivation, and separation inherent to the NICU environment make it difficult for many mothers to sustain breastfeeding and lactation, even when they want to. At the same time, NICU mothers are at elevated risk for post-traumatic stress disorder (PTSD) and poor health-related quality of life, which can further undermine lactation success and overall maternal wellbeing.
PeliCaN Multi-Site Breastfeeding tests whether a trained postpartum doula, working directly in the NICU can improve breastfeeding and lactation outcomes and support maternal mental health through 6 months postpartum. Participants are enrolled during their infant's NICU hospitalization to receive either doula support or standard care, depending on the study site condition at the time of enrollment (control vs. intervention). Mothers in the intervention group will receive lactation education and support, and emotional and informational support from a NICU-informed doula for up to 6 months. Mothers in the usual care group receive standard NICU clinical care, including access to NICU lactation consultants, without study doula support.
All participants complete surveys at enrollment and at 6 months postpartum covering infant feeding practices, maternal mental health, and demographic characteristics. The study asks two primary questions: (1) Does NICU-informed postpartum doula support improve breastfeeding and lactation rates at 6 months? (2) Does doula support improve health-related quality of life and reduce post-traumatic stress disorder symptoms at 6 months? A subset of intervention participants, NICU staff, and lactation consultants will also participate in qualitative interviews and brief implementation surveys to assess how well the doula program works in practice across participating sites.
Who Is on the Research Team?
Heather H Burris, MD, MPH
Principal Investigator
Children's Hospital of Philadelphia
Are You a Good Fit for This Trial?
This trial is for mothers with infants currently in the NICU. Participants are enrolled during their baby's hospital stay and must be interested in breastfeeding or lactation support. There are no detailed exclusion criteria listed.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- NICU-informed postpartum doula support
Trial Overview
The study tests whether having a trained postpartum doula provide emotional, informational, and breastfeeding support in the NICU helps mothers breastfeed longer and improves mental health compared to standard care without a doula.
How Is the Trial Designed?
2
Treatment groups
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital of Philadelphia
Lead Sponsor
University of Pennsylvania
Collaborator
Main Line Health
Collaborator
Pennsylvania Department of Health
Collaborator
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