PeliCaN: Post-partum Care in the NICU

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05510284
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Anticipated Duration (Months): 47.4

Study Details

Study Description

Brief Summary

This is a pilot randomized control trial to demonstrate the feasibility of a novel model of dyad-centered, doula-coordinated, midwife-delivered postpartum care located in the NICU in a large urban hospital.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Period	Other: Doula-coordinated, midwife-delivered postpartum care	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Post-partum Care in the NICU
• Anticipated Study Start Date: Sep 19, 2022
• Anticipated Primary Completion Date: Sep 1, 2025
• Anticipated Study Completion Date: Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention Arm Postpartum care will be doula-coordinated. The doula will meet with the mother at least once a week during their infant's NICU stay, with a minimum of 3 meetings. Participants will be given the option of seeing the study nurse midwife or their own provider. If the participant opts to see the nurse midwife, they can meet in a private office located in the NICU. The doula, as typical of the doula role, will coordinate any needed community services in the transition to home.	Other: Doula-coordinated, midwife-delivered postpartum care; A doula will coordinate all postpartum care and provide support to the participant. A midwife will be available on-site in the NICU to provide postpartum care.
No Intervention: Control Arm In this arm participants will receive usual postpartum care. They will be discharged from the hospital while their baby is still in the NICU and a plan will be made to for follow-up with their provider as an outpatient at some point in the next 6 weeks. The study coordinator will provide the participant with a community postpartum resources list.

Outcome Measures

Primary Outcome Measures

1. Time to receipt of postpartum care [birth until 6 weeks post-partum]

   To be analyzed using a wilcoxin rank sum test

Secondary Outcome Measures

1. Comparison of effectiveness of intervention for mothers with public vs private insurance [birth until 6 weeks post-partum]

   Time to receipt of postpartum care will be compared between mothers with public vs private insurance

2. Comparison of effectiveness of intervention for mothers with infants less than 29 weeks gestational age vs those 29 weeks or older. [birth until 6 weeks post-partum]

   Time to receipt of postpartum care will be compared between mothers with infants with a gestational age of less than or equal to 28 6/7 weeks vs a gestational age greater than or equal to 29 weeks

3. Receipt of Postpartum care [birth until 6 weeks post-partum]

   Binary (yes/no), fishers exact test

Other Outcome Measures

1. Health related quality of life measured by the CDC HRQOL14 [6 months postpartum]

   A 14 item survey in which a higher score represents a worse health related quality of life

2. Depression measured by the Edinburgh Postnatal Depression Scale [6 months postpartum]

   Scored with a maximum score

3. Health care utilization - Number of visits [Time of birth until 6 months postpartum]

   PhenXToolkit- 270101 Heathcare utilization and access survery

4. Breastfeeding- ever [6 months postpartum]

   PhenXToolkit-50101 BreasfeedingOutcomes: ever received breastmilk

5. Breastfeeding- length of time exclusive breastmilk [6 months postpartum]

   PhenXToolkit-50101 BreasfeedingOutcomes: length of time exclusive breastmilk

6. Breastfeeding- age at stopping breastmilk [6 months postpartum]

   PhenXToolkit-50101 BreasfeedingOutcomes:age at stopping breastmilk receipt (if relevant))

7. Diet [6 months postpartum]

   Dietary Screener Questionaire (DSQ) 30-items NHANES (Outcome: Cups of fruits or vegetables per day, [more is better])

8. Physical activity [6 months postpartum]

   International physical activity questionnaire - short form (Scored as Total physical activity, expressed as minutes per week)

9. Postraumatic stress disorder symptoms [6 months postpartum]

   PCL-5 checklist, Scored with a maximum score

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Preterm birth <34 weeks

• Signed medical record release form

Exclusion Criteria:

• Unable to read or sign informed consent

• If the medical team believes that the infant may die or be transferred to another hospital in upcoming weeks

• PI Discretion

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Pennsylvania

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heather Burris, Associate Professor of Pediatrics, University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT05510284
• Other Study ID Numbers: 851606
• First Posted: Aug 22, 2022
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 22, 2022