Timing of Inguinal Hernia Repair in Premature Infants

Completed · Not applicable

Conditions studied: Inguinal Hernia, Premature Birth of Newborn

In brief

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.

Key facts

Study ID

NCT01678638

Run by

Vanderbilt University Medical Center

People needed

338

Starts

2013-06-01

Expected to finish

2023-09-01

Last updated by the study team

2023-10-04

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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