Completed

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

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What is being tested

IH repair before NICU discharge

+ IH repair at 55-60 weeks post-menstrual age

Procedure
Who is being recruted

Urogenital Diseases+8

+ Female Urogenital Diseases and Pregnancy Complications

+ Hernia

+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: June 2013
See protocol details

Summary

Principal SponsorVanderbilt University Medical Center
Last updated: October 4, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01678638
Principal SponsorVanderbilt University Medical Center
Last updated: October 4, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

338 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHerniaObstetric Labor ComplicationsObstetric Labor, PrematurePregnancy ComplicationsPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalHernia, AbdominalHernia, InguinalPremature Birth

Criteria

4 inclusion criteria required to participate
Diagnosed with an IH per the pediatric surgery team
In a NICU at participating site
Infant with estimated gestational age at birth of < 37 weeks, 0 days
Parents and providers willing to randomize the infant
3 exclusion criteria prevent from participating
Family unable to return for follow up and later IH repair; or likely unable to monitor IH as outpatient
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
IH repair before NICU discharge

Group II

Active Comparator
IH repair as outpatient at approximately 55-60 weeks post-menstrual age

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 40 locations

University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama

Birmingham, United StatesOpen University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama in Google Maps

University of Arkansas for Medical Sciences; Arkansas Children's Hospital

Little Rock, United States

Southern California Permanente Group

Los Angeles, United States

University of California, Los Angeles David Geffen School of Medicine; Mattel Children's & LA Biomed

Los Angeles, United States
Completed40 Study Centers