MedTrace Logo

Timing of Inguinal Hernia Repair in Premature Infants

NCT01678638 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2023-10-04

No results posted yet for this study

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.

Conditions

  • Inguinal Hernia
  • Premature Birth of Newborn

Interventions

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Martin L Blakely, MD, MS · Vanderbilt University Medical Center

  • Jon E Tyson, MD, MPH · University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
37 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2023-04-30
Completion
2023-09-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01678638 on ClinicalTrials.gov