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

Eligibility

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

Inclusion Criteria

  • 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

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

ArmDescriptionAssigned 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 at 55-60 weeks post-menstrual age
  • Procedure: IH repair at 55-60 weeks post-menstrual age
    The IH repair will be performed between 55-60 weeks post-menstrual age.

Recruiting Locations

University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama
Birmingham, Alabama 35233
Contact:
Michelle Shroyer
205-638-9688

More Details

NCT ID
NCT01678638
Status
Recruiting
Sponsor
Vanderbilt University

Study Contact

Martin L Blakely, MD, MS
6159361050
martin.blakely@vanderbilt.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.