Doula Support for Breastfeeding

(PeliCaN Trial)

Not yet recruiting at 10 trial locations
HH
KE
Overseen ByKatey E Mari, PhD, MPH
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Children's Hospital of Philadelphia
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

HH

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

No restrictions to visiting their infant(s) in the NICU due to a significant social service issue such as incarceration
Delivery less than 34 weeks of gestation and intention to breastfeed or provide their own breastmilk to their infant
Postpartum parents less than or equal to 2 weeks postpartum
See 4 more

Exclusion Criteria

Unable to read or sign informed consent
Medical team believes that the infant may die or be transferred to another hospital within 1 week

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

Group I: Usual CareActive Control1 Intervention
Group II: NICU-informed Postpartum Doula SupportActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials
749
Recruited
11,400,000+

University of Pennsylvania

Collaborator

Trials
2,118
Recruited
45,270,000+

Main Line Health

Collaborator

Trials
22
Recruited
6,900+

Pennsylvania Department of Health

Collaborator

Trials
42
Recruited
999,000+