Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-09-11
2027-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Doula Support
Doula support including care coordination to mental and medical health services in the NICU, with a warm handoff to a community doula to continue the support once infants leave the HUP NICU.
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.
No interventions assigned to this group
Interventions
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Doula Support
Doula support including care coordination to mental and medical health services in the NICU, with a warm handoff to a community doula to continue the support once infants leave the HUP NICU.
Eligibility Criteria
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Inclusion Criteria
* Infant born at HUP
* Preterm birth \<34 weeks
* English language speaking
Exclusion Criteria
* 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
16 Years
FEMALE
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Heather Burris
Associate Professor of Pediatrics
Principal Investigators
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Heather Burris, MD MPH
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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855528
Identifier Type: -
Identifier Source: org_study_id
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