Postpartum Care in the NICU (PeliCaN) Transitions
Purpose
This is a randomized controlled trial of a dyad-centered, doula support and healthcare coordination model of care in a large urban neonatal intensive care unit (NICU), which serves a high-risk, low-income, majority Black population. In addition to doula support and coordination of care in the NICU, there will be a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU.
Conditions
- Stress Disorders, Post-Traumatic
 - Premature Birth
 - Postpartum Depression
 - Postpartum Anxiety
 
Eligibility
- Eligible Ages
 - Over 16 Years
 - Eligible Sex
 - Female
 - Accepts Healthy Volunteers
 - No
 
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
 
Study Design
- Phase
 - N/A
 - Study Type
 - Interventional
 - Allocation
 - Randomized
 - Intervention Model
 - Parallel Assignment
 - Primary Purpose
 - Supportive Care
 - Masking
 - None (Open Label)
 
Arm Groups
| Arm | Description | Assigned Intervention | 
|---|---|---|
| 
                        Experimental Doula Intervention  | 
                    Participants randomized to the intervention will be offered doula support including care coordination to mental and medical health services in the neonatal intensive care unit (NICU), with a warm handoff to a community doula to continue the support once infants leave the Hospital of the University of Pennsylvania (HUP) NICU. | 
                                                
  | 
                
| 
                        No Intervention Control  | 
                    Participants randomized to usual care will get the same care they normally would with their own provider, outside of research enrollment, and receive a resource guide with information about the importance of postpartum follow-up care. | 
                                                 | 
                
Recruiting Locations
More Details
- Status
 - Recruiting
 - Sponsor
 - University of Pennsylvania