Summary

at San Diego, California and other locations
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

Inguinal Hernia Premature Birth of Newborn premature infants anesthesia safety neurodevelopmental outcome preterm infants neonatal prematurity Premature Birth Hernia Hernia, Inguinal IH repair before NICU discharge IH repair at 55-60 weeks post-menstrual age Early inguinal hernia (IH) repair Late inguinal hernia (IH) repair

Eligibility

You can join if…

  • Infant with estimated gestational age < 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 CAN'T join 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

Locations

  • UCSD Rady Children's Hospital accepting new patients
    San Diego California 92123 United States
  • Naval Medical Center San Diego accepting new patients
    San Diego California 92103 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Vanderbilt University
ID
NCT01678638
Study Type
Interventional
Last Updated