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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01678638
Other study ID # 11-225-01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2013
Est. completion date September 2023

Study information

Verified date October 2023
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 338
Est. completion date September 2023
Est. primary completion date April 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 37 Weeks
Eligibility 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


Intervention

Procedure:
IH repair before NICU discharge
The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
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.

Locations

Country Name City State
United States Akron Children's Hospital Akron Ohio
United States Albany Medical Center Albany New York
United States University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama Birmingham Alabama
United States Tufts Medical Center Boston Massachusetts
United States Oishei Children's Hospital of Buffalo Buffalo New York
United States Medical University of South Carolina Charleston South Carolina
United States UVA Children's Hospital Charlottesville Virginia
United States Children's Hospital at Erlanger UT Chattanooga Chattanooga Tennessee
United States Cincinnati Children's Hospital Cincinnati Ohio
United States Ohio State University College of Medicine; Nationwide Children's Hospital Columbus Ohio
United States University of Texas, Southwestern Medical Center; Children's Medical Center Dallas Texas
United States Dayton Children's Hospital Dayton Ohio
United States Duke University Medical Center; Duke Children's Hospital and Health Center Durham North Carolina
United States UF Health Shands Children's Hospital Gainesville Florida
United States Connecticut Children's Medical Center Hartford Connecticut
United States Baylor College of Medicine; Texas Children's Hospital Houston Texas
United States University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital Houston Texas
United States University of Iowa Iowa City Iowa
United States Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
United States University of Arkansas for Medical Sciences; Arkansas Children's Hospital Little Rock Arkansas
United States Southern California Permanente Group Los Angeles California
United States University of California, Los Angeles David Geffen School of Medicine; Mattel Children's & LA Biomed Los Angeles California
United States Valley Children's Hospital Madera California
United States University of Tennessee Health Science Center; Le Bonheur Children's Hospital Memphis Tennessee
United States Medical College of Wisconsin; Children's Hospital of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Medical School; Amplatz Children's Hospital Minneapolis Minnesota
United States Monroe Carell Jr. Children's Hospital at Vanderbilt Nashville Tennessee
United States Columbia University Irving Medical Center New York New York
United States Children's Hospital & Medical Center of Omaha Omaha Nebraska
United States OHSU Doernbecher Children's Hospital Portland Oregon
United States Women & Infants Hospital of Rhode Island Providence Rhode Island
United States Cohen Children's Medical Center Queens New York
United States Virginia Commonwealth University Medical Center; Children's Hospital of Richmond Richmond Virginia
United States SSM Health Cardinal Glennon Children's Hospital Saint Louis Missouri
United States Washington University School of Medicine in St. Louis; St. Louis Children's Hospital Saint Louis Missouri
United States Johns Hopkins All Children's Hospital Saint Petersburg Florida
United States Primary Children's Hospital University of Utah Salt Lake City Utah
United States Naval Medical Center San Diego San Diego California
United States UCSD Rady Children's Hospital San Diego California
United States University of Washington School of Medicine; Seattle Children's Hospital Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt University Medical Center The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Significant adverse event (SAE) rate Specific significant adverse events that are either treatment related or hernia related have been defined a priori and will be assessed in both groups from randomization until 9 months after NICU discharge. 9 months beyond NICU discharge
Primary Number of hospital days Total number of hospital days From randomization until 9 months post NICU discharge
Secondary Hospital costs Departmental level costs at each participating institution will be determined for care that occurs from randomization until 9 months post NICU discharge. Enrollment through 9 months after NICU discharge
Secondary Bayley Scales of Infant Development, 3rd Edition Mean BSID scores; primarily cognitive domain 22-26 months corrected age
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