Timing of Inguinal Hernia Repair in Premature Infants
- Conditions
- Premature Birth of NewbornInguinal Hernia
- Interventions
- Procedure: IH repair at 55-60 weeks post-menstrual ageProcedure: IH repair before NICU discharge
- Registration Number
- NCT01678638
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief 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.
- Detailed Description
This is a randomized clinical trial comparing early versus late repair in premature infants with an inguinal hernia (IH) to determine which approach may be safer. Safety in this trial is defined as the freedom from significant adverse events, a reduction in hospital days during the study period, and normal neurodevelopmental testing at 2 years. Costs of each treatment strategy are also important and are being evaluated.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 338
- 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
- Infant is undergoing another operative procedure and IH repair is planned as a secondary procedure (e.g. fundoplication or G tube is planned, and IH repair is considered a secondary procedure)
- Known major congenital anomaly that impacts neurodevelopmental outcome or chromosomal abnormality
- Family unable to return for follow up and later IH repair; or likely unable to monitor IH as outpatient
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Late inguinal hernia (IH) repair IH repair at 55-60 weeks post-menstrual age IH repair as outpatient at approximately 55-60 weeks post-menstrual age Early inguinal hernia (IH) repair IH repair before NICU discharge IH repair before NICU discharge
- Primary Outcome Measures
Name Time Method Significant adverse event (SAE) rate 9 months beyond NICU discharge Specific significant adverse events that are either treatment related or hernia related have been defined a priori and will be assessed in both groups from randomization until 9 months after NICU discharge.
Number of hospital days From randomization until 9 months post NICU discharge Total number of hospital days
- Secondary Outcome Measures
Name Time Method Bayley Scales of Infant Development, 3rd Edition 22-26 months corrected age Mean BSID scores; primarily cognitive domain
Hospital costs Enrollment through 9 months after NICU discharge Departmental level costs at each participating institution will be determined for care that occurs from randomization until 9 months post NICU discharge.
Trial Locations
- Locations (40)
University of Texas, Southwestern Medical Center; Children's Medical Center
🇺🇸Dallas, Texas, United States
University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
🇺🇸Houston, Texas, United States
University of Washington School of Medicine; Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
University of Arkansas for Medical Sciences; Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Naval Medical Center San Diego
🇺🇸San Diego, California, United States
University of Minnesota Medical School; Amplatz Children's Hospital
🇺🇸Minneapolis, Minnesota, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
OHSU Doernbecher Children's Hospital
🇺🇸Portland, Oregon, United States
University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama
🇺🇸Birmingham, Alabama, United States
University of California, Los Angeles David Geffen School of Medicine; Mattel Children's & LA Biomed
🇺🇸Los Angeles, California, United States
Southern California Permanente Group
🇺🇸Los Angeles, California, United States
Valley Children's Hospital
🇺🇸Madera, California, United States
UCSD Rady Children's Hospital
🇺🇸San Diego, California, United States
Johns Hopkins All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
SSM Health Cardinal Glennon Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Washington University School of Medicine in St. Louis; St. Louis Children's Hospital
🇺🇸Saint Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Cohen Children's Medical Center
🇺🇸Queens, New York, United States
Columbia University Irving Medical Center
🇺🇸New York, New York, United States
Oishei Children's Hospital of Buffalo
🇺🇸Buffalo, New York, United States
Albany Medical Center
🇺🇸Albany, New York, United States
Akron Children's Hospital
🇺🇸Akron, Ohio, United States
Ohio State University College of Medicine; Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Duke University Medical Center; Duke Children's Hospital and Health Center
🇺🇸Durham, North Carolina, United States
Dayton Children's Hospital
🇺🇸Dayton, Ohio, United States
Women & Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
Children's Hospital at Erlanger UT Chattanooga
🇺🇸Chattanooga, Tennessee, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
🇺🇸Nashville, Tennessee, United States
University of Tennessee Health Science Center; Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
Baylor College of Medicine; Texas Children's Hospital
🇺🇸Houston, Texas, United States
Primary Children's Hospital University of Utah
🇺🇸Salt Lake City, Utah, United States
UVA Children's Hospital
🇺🇸Charlottesville, Virginia, United States
Children's Hospital & Medical Center of Omaha
🇺🇸Omaha, Nebraska, United States
UF Health Shands Children's Hospital
🇺🇸Gainesville, Florida, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Virginia Commonwealth University Medical Center; Children's Hospital of Richmond
🇺🇸Richmond, Virginia, United States
Medical College of Wisconsin; Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States