Timing of Inguinal Hernia Repair in Premature Infants

Inguinal Hernia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678638
• Other study ID #: 11-225-01
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Premature Birth
• Premature Birth of Newborn

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