Timing of Inguinal Hernia Repair in Premature Infants
1 other identifier
interventional
338
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2013
Longer than P75 for not_applicable
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2012
CompletedFirst Posted
Study publicly available on registry
September 5, 2012
CompletedStudy Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedOctober 4, 2023
October 1, 2023
9.8 years
August 30, 2012
October 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Significant adverse event (SAE) rate
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.
9 months beyond NICU discharge
Number of hospital days
Total number of hospital days
From randomization until 9 months post NICU discharge
Secondary Outcomes (2)
Hospital costs
Enrollment through 9 months after NICU discharge
Bayley Scales of Infant Development, 3rd Edition
22-26 months corrected age
Study Arms (2)
Early inguinal hernia (IH) repair
ACTIVE COMPARATORIH repair before NICU discharge
Late inguinal hernia (IH) repair
ACTIVE COMPARATORIH repair as outpatient at approximately 55-60 weeks post-menstrual age
Interventions
The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
The IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama
Birmingham, Alabama, 35233, United States
University of Arkansas for Medical Sciences; Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Southern California Permanente Group
Los Angeles, California, 90027, United States
University of California, Los Angeles David Geffen School of Medicine; Mattel Children's & LA Biomed
Los Angeles, California, 90095, United States
Valley Children's Hospital
Madera, California, 93636, United States
Naval Medical Center San Diego
San Diego, California, 92103, United States
UCSD Rady Children's Hospital
San Diego, California, 92123, United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
UF Health Shands Children's Hospital
Gainesville, Florida, 32608, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
University of Minnesota Medical School; Amplatz Children's Hospital
Minneapolis, Minnesota, 55455, United States
SSM Health Cardinal Glennon Children's Hospital
St Louis, Missouri, 63104, United States
Washington University School of Medicine in St. Louis; St. Louis Children's Hospital
St Louis, Missouri, 63110, United States
Children's Hospital & Medical Center of Omaha
Omaha, Nebraska, 68114, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Albany Medical Center
Albany, New York, 12208, United States
Oishei Children's Hospital of Buffalo
Buffalo, New York, 14203, United States
Columbia University Irving Medical Center
New York, New York, 10032, United States
Cohen Children's Medical Center
Queens, New York, 11040, United States
Duke University Medical Center; Duke Children's Hospital and Health Center
Durham, North Carolina, 27710, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Ohio State University College of Medicine; Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Dayton Children's Hospital
Dayton, Ohio, 45404, United States
OHSU Doernbecher Children's Hospital
Portland, Oregon, 97239, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Children's Hospital at Erlanger UT Chattanooga
Chattanooga, Tennessee, 37403, United States
University of Tennessee Health Science Center; Le Bonheur Children's Hospital
Memphis, Tennessee, 38103, United States
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
University of Texas, Southwestern Medical Center; Children's Medical Center
Dallas, Texas, 75235, United States
Baylor College of Medicine; Texas Children's Hospital
Houston, Texas, 77030, United States
University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
Houston, Texas, 77030, United States
Primary Children's Hospital University of Utah
Salt Lake City, Utah, 84113, United States
UVA Children's Hospital
Charlottesville, Virginia, 22903, United States
Virginia Commonwealth University Medical Center; Children's Hospital of Richmond
Richmond, Virginia, 23284, United States
University of Washington School of Medicine; Seattle Children's Hospital
Seattle, Washington, 98105, United States
Medical College of Wisconsin; Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 38530261DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin L Blakely, MD, MS
Vanderbilt University Medical Center
- PRINCIPAL INVESTIGATOR
Jon E Tyson, MD, MPH
University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatric Surgery and Pediatrics
Study Record Dates
First Submitted
August 30, 2012
First Posted
September 5, 2012
Study Start
June 1, 2013
Primary Completion
April 1, 2023
Study Completion
September 1, 2023
Last Updated
October 4, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share