NCT01678638

Timing of Inguinal Hernia Repair in Premature Infants

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 37 Weeks
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Inguinal Hernia
• Premature Birth of Newborn

Interventions

Type	Name	Description
PROCEDURE	IH repair before NICU discharge	The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
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.

Timeline

• Start date: 2013-06-01
• Primary completion: 2023-04-01
• Completion: 2023-09-01
• First posted: 2012-09-05
• Last updated: 2023-10-04

Locations

40 sites across 1 country: United States