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NOT YET RECRUITING
NCT07881731
NA

Postpartum Care in the NICU Multi-Site Breastfeeding

Sponsor: Children's Hospital of Philadelphia

View on ClinicalTrials.gov

Summary

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.

Official title: Postpartum Care in the NICU (PeliCaN) for Maternal Wellbeing and Breastfeeding

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

640

Start Date

2027-01-01

Completion Date

2030-06-01

Last Updated

2026-10-19

Healthy Volunteers

No

Interventions

OTHER

NICU-informed postpartum doula support

Intervention participants will receive support from a trained NICU-informed postpartum doula for up to 6 months across four domains: 1. Lactation Consultant Coordination: Doulas will review and reinforce NICU lactation consultant recommendations and facilitate continuity of lactation support through discharge. 2. Pumping Assistance: Doulas will provide hands-on guidance on pump settings, flange fitting, and hand expression; support adherence to pumping schedules; assist with milk tracking, storage, and transport; and provide each participant with a fitted pumping bra. 3. Emotional Support: Doulas will provide reassurance and emotional support throughout the NICU stay, promote bonding practices including skin-to-skin contact, and facilitate mental health referrals when needed. 4. Nutritional Support: Doulas will provide lactation nutrition education and connect participants with community resources including food banks and WIC.

Locations (11)

Bryn Mawr Hospital

Bryn Mawr, Pennsylvania, United States

Children's Hospital of Philadelphia King of Prussia Hospital

King of Prussia, Pennsylvania, United States

Lancaster General Health Women & Babies Hospital

Lancaster, Pennsylvania, United States

Riddle Hospital

Media, Pennsylvania, United States

Jefferson Einstein Montgomery Hospital

Norristown, Pennsylvania, United States

Paoli Hospital

Paoli, Pennsylvania, United States

Lankenau Medical Center

Penn Wynne, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

The Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Chester County Hospital

West Chester, Pennsylvania, United States