Timing of Inguinal Hernia Repair in Premature Infants

Timing of Inguinal Hernia Repair in Premature Infants: A Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Inguinal Hernia; Premature Birth of Newborn
• Intervention / Treatment: Procedure: IH repair before NICU discharge; Procedure: IH repair at 55-60 weeks post-menstrual age

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.

• Study Type: Interventional
• Enrollment (Actual): 338
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • University of Arkansas for Medical Sciences; Arkansas Children's Hospital
  • California
    • Los Angeles, California, United States, 90027
      • Southern California Permanente Group
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles David Geffen School of Medicine; Mattel Children's & LA Biomed
    • Madera, California, United States, 93636
      • Valley Children's Hospital
    • San Diego, California, United States, 92123
      • UCSD Rady Children's Hospital
    • San Diego, California, United States, 92103
      • Naval Medical Center San Diego
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Connecticut Children's Medical Center
  • Florida
    • Gainesville, Florida, United States, 32608
      • UF Health Shands Children's Hospital
    • Saint Petersburg, Florida, United States, 33701
      • Johns Hopkins All Children's Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical School; Amplatz Children's Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • SSM Health Cardinal Glennon Children's Hospital
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine in St. Louis; St. Louis Children's Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Children's Hospital & Medical Center of Omaha
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center
    • Buffalo, New York, United States, 14203
      • Oishei Children's Hospital of Buffalo
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center
    • Queens, New York, United States, 11040
      • Cohen Children's Medical Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center; Duke Children's Hospital and Health Center
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital
    • Columbus, Ohio, United States, 43205
      • Ohio State University College of Medicine; Nationwide Children's Hospital
    • Dayton, Ohio, United States, 45404
      • Dayton Children's Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Doernbecher Children's Hospital
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Women & Infants Hospital of Rhode Island
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Children's Hospital at Erlanger UT Chattanooga
    • Memphis, Tennessee, United States, 38103
      • University of Tennessee Health Science Center; Le Bonheur Children's Hospital
    • Nashville, Tennessee, United States, 37232
      • Monroe Carell Jr. Children's Hospital at Vanderbilt
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas, Southwestern Medical Center; Children's Medical Center
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine; Texas Children's Hospital
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Hospital University of Utah
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • UVA Children's Hospital
    • Richmond, Virginia, United States, 23284
      • Virginia Commonwealth University Medical Center; Children's Hospital of Richmond
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington School of Medicine; Seattle Children's Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin; Children's Hospital of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 8 months (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early inguinal hernia (IH) repair; IH repair before NICU discharge	Procedure: IH repair before NICU discharge; The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
Active Comparator: Late inguinal hernia (IH) repair; IH repair as outpatient at approximately 55-60 weeks post-menstrual age	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital costs	Departmental level costs at each participating institution will be determined for care that occurs from randomization until 9 months post NICU discharge.	Enrollment through 9 months after NICU discharge
Bayley Scales of Infant Development, 3rd Edition	Mean BSID scores; primarily cognitive domain	22-26 months corrected age

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: The University of Texas Health Science Center, Houston
• Investigators: 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 record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: August 30, 2012
• First Submitted That Met QC Criteria: September 4, 2012
• First Posted (Estimated): September 5, 2012

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: preterm infants; premature infants; inguinal hernia; neurodevelopmental outcome; neonatal prematurity; anesthesia safety
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hernia; Hernia, Inguinal; Premature Birth
• Other Study ID Numbers: 11-225-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO