Vanderbilt Clinical Trials

Timing of Inguinal Hernia Repair in Premature Infants

Purpose

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.

Conditions

Inguinal Hernia
Premature Birth of Newborn

Eligibility

Eligible Ages: Under 37 Weeks
Eligible Genders: All
Accepts Healthy Volunteers: No

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 Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
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.

More Details

Status: Completed
Sponsor: Vanderbilt University Medical Center

Study Contact

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.