Postpartum Care in the NICU (PeliCaN) Transitions

University of Pennsylvania

Status: Enrolling

Conditions: Postpartum Anxiety; Stress Disorders, Post-Traumatic; Postpartum Depression; Premature Birth

Treatments: Other: Doula Support

Study type: Interventional

Funder types: Other

Identifiers

NCT06521398

855528

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Doula Intervention

Experimental group

Description:

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.

Treatment:

Other: Doula Support

Control

No Intervention group

Description:

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.