Postpartum Care in the NICU Multi-Site Breastfeeding
Public ClinicalTrials.gov record NCT07881731. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Postpartum Care in the NICU (PeliCaN) for Maternal Wellbeing and Breastfeeding
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07881731
- Recruitment status
- Not yet recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 640 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 1, 2027 (Estimated)
- Primary completion
- Mar 30, 2029 (Estimated)
- Completion
- Jun 1, 2030 (Estimated)
- Last update posted
- Oct 19, 2026
2027 – 2030
United States locations
- U.S. sites
- 11
- U.S. states
- 1
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | — |
| Children's Hospital of Philadelphia King of Prussia Hospital | King of Prussia | Pennsylvania | 19406 | — |
| Lancaster General Health Women & Babies Hospital | Lancaster | Pennsylvania | 17601 | — |
| Riddle Hospital | Media | Pennsylvania | 19063 | — |
| Jefferson Einstein Montgomery Hospital | Norristown | Pennsylvania | 19403 | — |
| Paoli Hospital | Paoli | Pennsylvania | 19301 | — |
| Lankenau Medical Center | Penn Wynne | Pennsylvania | 19096 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| The Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Chester County Hospital | West Chester | Pennsylvania | 19380 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07881731, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 19, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07881731 live on ClinicalTrials.gov.