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Postpartum Care in the NICU (PeliCaN Trial)

N/A

Waitlist Available

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months postpartum

Awards & highlights

PeliCaN Trial Summary

This trial explores a new model of postpartum care in a hospital to better support mothers and babies.

Who is the study for?

This trial is for mothers who have given birth prematurely (before 34 weeks) and are in the NICU of a large urban hospital. They must be able to sign a medical record release form. Mothers cannot participate if they can't read or consent to the study, or if their baby might pass away or be moved to another hospital soon.Check my eligibility

What is being tested?

The trial is testing a new way of caring for mother-baby pairs after birth with services coordinated by doulas and delivered by midwives right in the NICU. It's designed to see how well this approach works in a real-world setting.See study design

What are the potential side effects?

Since this intervention involves non-medical support, there may not be direct side effects like those seen with medications; however, emotional distress or dissatisfaction with care could potentially occur.

PeliCaN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to receipt of postpartum care

Secondary outcome measures

Comparison of effectiveness of intervention for mothers with infants less than 29 weeks gestational age vs those 29 weeks or older.

Comparison of effectiveness of intervention for mothers with public vs private insurance

Receipt of Postpartum care

Other outcome measures

Breastfeeding- age at stopping breastmilk

Breastfeeding- ever

Breastfeeding- length of time exclusive breastmilk

+6 more

PeliCaN Trial Design

2Treatment groups

Active Control

Group I: Standard Postpartum Care ArmActive Control1 Intervention

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.

Group II: Doula Coordinated-Care ArmActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,000 Previous Clinical Trials

42,880,051 Total Patients Enrolled

Media Library

Doula-coordinated, midwife-delivered postpartum care Clinical Trial Eligibility Overview. Trial Name: NCT05510284 — N/A

Postpartum Research Study Groups: Standard Postpartum Care Arm, Doula Coordinated-Care Arm

Postpartum Clinical Trial 2023: Doula-coordinated, midwife-delivered postpartum care Highlights & Side Effects. Trial Name: NCT05510284 — N/A

Doula-coordinated, midwife-delivered postpartum care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05510284 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the highest number of participants this clinical trial can accommodate?

"Absolutely, evidence posted to clinicaltrials.gov indicates that this experiment is actively seeking participants. This study was initially published on November 29th 2022 and the last update occurred January 20th 2023. There are 40 prospective patients needed from a single site for enrolment."

Answered by AI

Is enrollment open at this time for the research project?

"Affirmative. Data on clinicaltrials.gov attests to this examination's ongoing recruitment process which began on November 29th 2022 and was last updated January 20th 2023. 40 patients need to be recruited from 1 participating site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Post-partum Care in the NICU

Heather Burris 2022. "Post-partum Care in the NICU". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05510284.