Support for new parents in the NICU
Postpartum Care in the NICU (PeliCaN) Transitions
This study tests whether having a doula to support new parents in the NICU can help reduce stress and anxiety for those with preterm infants, especially for families from low-income backgrounds.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 16 Years and up |
| Sex | Female |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06521398 on ClinicalTrials.gov |
What this trial studies
This trial evaluates a doula support and healthcare coordination model for postpartum patients in a neonatal intensive care unit (NICU) at the Hospital of the University of Pennsylvania. It focuses on providing continuous support to parents of preterm infants, particularly those from high-risk, low-income backgrounds. The intervention includes both in-hospital doula support and a transition to community doula services after discharge. The aim is to improve mental health outcomes for parents dealing with stress and anxiety related to their infants' care.
Who should consider this trial
Good fit: Ideal candidates are postpartum patients at least 16 years old with infants born preterm at the Hospital of the University of Pennsylvania.
Not a fit: Patients whose infants are transferred to another hospital or who are under 16 years of age at the time of birth may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the mental health and well-being of parents with preterm infants.
How similar studies have performed: Other studies have shown positive outcomes with doula support in similar contexts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * HUP postpartum patients who are at least 16 years old at the time their newborns' birth * Infant born at HUP * Preterm birth \<34 weeks * English language speaking Exclusion Criteria: * Unable to read or sign informed consent * Parents of infants transferred into HUP NICU * If the medical team believes that the infant may not live or be transferred to another hospital in upcoming weeks * HUP postpartum patients who are less than 16 years of age at the time of their newborns' birth
Where this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Heather Burris, MD MPH — University of Pennsylvania
- Study coordinator: Heather Burris, MD MPH
- Email: Burrish@chop.edu
- Phone: (215) 573-4916
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.