Type of Material in Repair of Congenital Diaphragmatic Hernia
SD
Overseen byShawn D St. Peter, MD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Children's Mercy Hospital Kansas City
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The objective of this study is to evaluate the use of 2 different types of biosynthetic material for the repair of congenital diaphragmatic hernia. The research question is: what is the best material for repairing large congenital diaphragmatic hernias? The primary outcome variable is recurrence.
Research Team
SD
Shawn D St. Peter, MD
Principal Investigator
Children's Mercy Hospital Kansas City
Eligibility Criteria
Inclusion Criteria
Infants admitted to the neonatal intensive care unit with a diagnosis of congenital diaphragmatic hernia as proven by chest x-ray showing enteric contents in the thoracic cavity will be considered. Those who have birth weight equal to or over 2.2 kilograms and who are at or beyond 34 weeks gestation at the time of birth who survive until an operation can be performed will be considered. At operation, the patients with posterolateral diaphragmatic defects (Bockdalek Hernia) large enough to require placement of a patch to recreate the diaphragm will be included in the study.
Treatment Details
Interventions
- Biosynthetic Material (Biosynthetic Material)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Mercy Hospital Kansas City
Lead Sponsor
Trials
261
Recruited
941,000+
Dr. Alejandro Quiroga
Children's Mercy Hospital Kansas City
Chief Executive Officer
MD from Universidad Del Rosario, MBA
Dr. Doug Blowey
Children's Mercy Hospital Kansas City
Chief Medical Officer since 2023
MD from University of Kansas