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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
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 moreTrial 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.
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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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 14 and 45 years old.I have had organ failure or other cancers in the past.I am female.I plan to get pediatric care at one of the specified locations.
Research Study Groups:
This trial has the following groups:- Group 1: CCAPB (intervention)
- Group 2: Usual Care
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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