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Care Coordination for Premature Birth

N/A
Recruiting
Led By Emily Gregory, MD, MPH
Research Sponsored by Children's Hospital of Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months

Summary

This trial studies an adapted behavior intervention to help preterm babies. It's being tested to check its effectiveness & feasibility.

Who is the study for?
This trial is for females aged 14-45 with a history of preterm birth, intending to seek pediatric care at specific sites and have Medicaid. They must not plan to move or transfer care within six months, have limited English proficiency, a history of sterilization, organ failure or cancer.
What is being tested?
The study tests the Care Coordination After Preterm Birth (CCAPB) program in a small-scale randomized controlled trial to see if it's practical and can be implemented widely. Participants will be assessed before and after the intervention.
What are the potential side effects?
Since CCAPB is a behavioral intervention focusing on care coordination rather than medication or medical procedures, there are no direct side effects like those associated with drugs or surgeries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability of the CCAPB intervention
Secondary study objectives
Autonomous motivation
Autonomy Support
Completion of recommended postpartum care
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CCAPB (intervention)Experimental Treatment1 Intervention
Intervention participants will receive an intervention focused on health care navigation and motivational enhancement.
Group II: Usual CarePlacebo Group1 Intervention
Usual care participants will not receive the intervention.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,051 Previous Clinical Trials
2,731,448 Total Patients Enrolled
71 Trials studying Premature Birth
121,471 Patients Enrolled for Premature Birth
Children's Hospital of PhiladelphiaLead Sponsor
729 Previous Clinical Trials
8,470,215 Total Patients Enrolled
12 Trials studying Premature Birth
4,105 Patients Enrolled for Premature Birth
University of PennsylvaniaOTHER
2,075 Previous Clinical Trials
42,719,750 Total Patients Enrolled
23 Trials studying Premature Birth
12,008 Patients Enrolled for Premature Birth

Media Library

Care Coordination after Preterm Birth (CCAPB) Clinical Trial Eligibility Overview. Trial Name: NCT05756634 — N/A
Premature Birth Research Study Groups: CCAPB (intervention), Usual Care
Premature Birth Clinical Trial 2023: Care Coordination after Preterm Birth (CCAPB) Highlights & Side Effects. Trial Name: NCT05756634 — N/A
Care Coordination after Preterm Birth (CCAPB) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05756634 — N/A
~35 spots leftby Sep 2025