Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
338 participants
INTERVENTIONAL
2013-06-30
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Early inguinal hernia (IH) repair
IH repair before NICU discharge
IH repair before NICU discharge
The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
Late inguinal hernia (IH) repair
IH repair as outpatient at approximately 55-60 weeks post-menstrual age
IH repair at 55-60 weeks post-menstrual age
The IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age.
Interventions
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IH repair before NICU discharge
The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
IH repair at 55-60 weeks post-menstrual age
The IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age.
Eligibility Criteria
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Inclusion Criteria
* In a NICU at participating site
* Diagnosed with an IH per the pediatric surgery team
* Parents and providers willing to randomize the infant
Exclusion Criteria
* 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
37 Weeks
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Vanderbilt University Medical Center
OTHER
Responsible Party
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Martin Blakely
Associate Professor of Pediatric Surgery and Pediatrics
Principal Investigators
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Martin L Blakely, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Jon E Tyson, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
Locations
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University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama
Birmingham, Alabama, United States
University of Arkansas for Medical Sciences; Arkansas Children's Hospital
Little Rock, Arkansas, United States
Southern California Permanente Group
Los Angeles, California, United States
University of California, Los Angeles David Geffen School of Medicine; Mattel Children's & LA Biomed
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
Naval Medical Center San Diego
San Diego, California, United States
UCSD Rady Children's Hospital
San Diego, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
UF Health Shands Children's Hospital
Gainesville, Florida, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
University of Iowa
Iowa City, Iowa, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Minnesota Medical School; Amplatz Children's Hospital
Minneapolis, Minnesota, United States
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, United States
Washington University School of Medicine in St. Louis; St. Louis Children's Hospital
St Louis, Missouri, United States
Children's Hospital & Medical Center of Omaha
Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Albany Medical Center
Albany, New York, United States
Oishei Children's Hospital of Buffalo
Buffalo, New York, United States
Columbia University Irving Medical Center
New York, New York, United States
Cohen Children's Medical Center
Queens, New York, United States
Duke University Medical Center; Duke Children's Hospital and Health Center
Durham, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Ohio State University College of Medicine; Nationwide Children's Hospital
Columbus, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
OHSU Doernbecher Children's Hospital
Portland, Oregon, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Children's Hospital at Erlanger UT Chattanooga
Chattanooga, Tennessee, United States
University of Tennessee Health Science Center; Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
University of Texas, Southwestern Medical Center; Children's Medical Center
Dallas, Texas, United States
Baylor College of Medicine; Texas Children's Hospital
Houston, Texas, United States
University of Texas Health Science Center at Houston; Children's Memorial Hermann 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
Virginia Commonwealth University Medical Center; Children's Hospital of Richmond
Richmond, Virginia, United States
University of Washington School of Medicine; Seattle Children's Hospital
Seattle, Washington, United States
Medical College of Wisconsin; Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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HIP Trial Investigators; Blakely ML, Krzyzaniak A, Dassinger MS, Pedroza C, Weitkamp JH, Gosain A, Cotten M, Hintz SR, Rice H, Courtney SE, Lally KP, Ambalavanan N, Bendel CM, Bui KCT, Calkins C, Chandler NM, Dasgupta R, Davis JM, Deans K, DeUgarte DA, Gander J, Jackson CA, Keszler M, Kling K, Fenton SJ, Fisher KA, Hartman T, Huang EY, Islam S, Koch F, Lainwala S, Lesher A, Lopez M, Misra M, Overbey J, Poindexter B, Russell R, Stylianos S, Tamura DY, Yoder BA, Lucas D, Shaul D, Ham PB 3rd, Fitzpatrick C, Calkins K, Garrison A, de la Cruz D, Abdessalam S, Kvasnovsky C, Segura BJ, Shilyansky J, Smith LM, Tyson JE. Effect of Early vs Late Inguinal Hernia Repair on Serious Adverse Event Rates in Preterm Infants: A Randomized Clinical Trial. JAMA. 2024 Mar 26;331(12):1035-1044. doi: 10.1001/jama.2024.2302.
Other Identifiers
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11-225-01
Identifier Type: -
Identifier Source: org_study_id
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