Timing of Inguinal Hernia Repair in Premature Infants

Vanderbilt University Medical Center

Status

Completed

Conditions

Premature Birth of Newborn

Inguinal Hernia

Treatments

Procedure: IH repair before NICU discharge

Procedure: IH repair at 55-60 weeks post-menstrual age

Study type

Interventional

Funder types

Other

Identifiers

NCT01678638

11-225-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

338 patients

Sex

All

Ages

Under 37 weeks old

Volunteers

No Healthy Volunteers

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