Timing of Inguinal Hernia Repair in Premature Infants: A Randomized Trial
Status: Completed
Location: See all (40) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to determine whether early (before NICU discharge) or late (55-60 weeks post-menstrual age) inguinal hernia repair is safer for premature infants who have an inguinal hernia.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 8 months
Healthy Volunteers: f
View:
• Infant with estimated gestational age at birth of \< 37 weeks, 0 days
• In a NICU at participating site
• Diagnosed with an IH per the pediatric surgery team
• Parents and providers willing to randomize the infant
Locations
United States
Alabama
University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama
Birmingham
Arkansas
University of Arkansas for Medical Sciences; Arkansas Children's Hospital
Little Rock
California
Southern California Permanente Group
Los Angeles
University of California, Los Angeles David Geffen School of Medicine; Mattel Children's & LA Biomed
Los Angeles
Valley Children's Hospital
Madera
Naval Medical Center San Diego
San Diego
UCSD Rady Children's Hospital
San Diego
Connecticut
Connecticut Children's Medical Center
Hartford
Florida
UF Health Shands Children's Hospital
Gainesville
Johns Hopkins All Children's Hospital
Saint Petersburg
Iowa
University of Iowa
Iowa City
Massachusetts
Tufts Medical Center
Boston
Minnesota
University of Minnesota Medical School; Amplatz Children's Hospital
Minneapolis
Missouri
SSM Health Cardinal Glennon Children's Hospital
Saint Louis
Washington University School of Medicine in St. Louis; St. Louis Children's Hospital
Saint Louis
North Carolina
Duke University Medical Center; Duke Children's Hospital and Health Center
Durham
Nebraska
Children's Hospital & Medical Center of Omaha
Omaha
New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon
New York
Albany Medical Center
Albany
Oishei Children's Hospital of Buffalo
Buffalo
Columbia University Irving Medical Center
New York
Cohen Children's Medical Center
Queens
Ohio
Akron Children's Hospital
Akron
Cincinnati Children's Hospital
Cincinnati
Ohio State University College of Medicine; Nationwide Children's Hospital
Columbus
Dayton Children's Hospital
Dayton
Oregon
OHSU Doernbecher Children's Hospital
Portland
Rhode Island
Women & Infants Hospital of Rhode Island
Providence
South Carolina
Medical University of South Carolina
Charleston
Tennessee
Children's Hospital at Erlanger UT Chattanooga
Chattanooga
University of Tennessee Health Science Center; Le Bonheur Children's Hospital
Memphis
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville
Texas
University of Texas, Southwestern Medical Center; Children's Medical Center
Dallas
Baylor College of Medicine; Texas Children's Hospital
Houston
University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
Houston
Utah
Primary Children's Hospital University of Utah
Salt Lake City
Virginia
UVA Children's Hospital
Charlottesville
Virginia Commonwealth University Medical Center; Children's Hospital of Richmond
Richmond
Washington
University of Washington School of Medicine; Seattle Children's Hospital
Seattle
Wisconsin
Medical College of Wisconsin; Children's Hospital of Wisconsin
Milwaukee
Time Frame
Start Date: 2013-06
Completion Date: 2023-09
Participants
Target number of participants: 338
Treatments
Active_comparator: Early inguinal hernia (IH) repair
IH repair before NICU discharge
Active_comparator: Late inguinal hernia (IH) repair
IH repair as outpatient at approximately 55-60 weeks post-menstrual age
Authors
Saleem Islam, Aaron Garrison, Lynne Smith, Meghna Misra, Douglas Tamura, KuoJen Tsao, Katherine Deans, Eunice Huang, Karen Kling, Joel Shilyansky, Elizabeth Renaud, Steven Stylianos, Avraham Schlager, Donald Shaul, Martin Blakely, Adam Alder, Howard Jen, Adam Goldin, Casey Calkins, Jonathan Davis, Martin Keszler, Daniel DeUgarte, Shawn St. Peter, Marya Strand, Obinna Adibe, Richard Weiss, Aaron Lesher, Shahab Abdessalam, Jacqueline Saito, Jeffrey Gander, Nicole Chandler
Related Therapeutic Areas
Sponsors
Collaborators: The University of Texas Health Science Center, Houston
Leads: Vanderbilt University Medical Center