Back to resultsTiming of Inguinal Hernia Repair in Premature Infants
Primary Purpose
Inguinal Hernia, Premature Birth of Newborn
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IH repair before NICU discharge
IH repair at 55-60 weeks post-menstrual age
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring inguinal hernia, premature infants, anesthesia safety, neurodevelopmental outcome, preterm infants, neonatal prematurity
Eligibility Criteria
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
Sites / Locations
- University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama
- University of Arkansas for Medical Sciences; Arkansas Children's Hospital
- Southern California Permanente Group
- University of California, Los Angeles David Geffen School of Medicine; Mattel Children's & LA Biomed
- Valley Children's Hospital
- Naval Medical Center San Diego
- UCSD Rady Children's Hospital
- Connecticut Children's Medical Center
- UF Health Shands Children's Hospital
- Johns Hopkins All Children's Hospital
- University of Iowa
- Tufts Medical Center
- University of Minnesota Medical School; Amplatz Children's Hospital
- SSM Health Cardinal Glennon Children's Hospital
- Washington University School of Medicine in St. Louis; St. Louis Children's Hospital
- Children's Hospital & Medical Center of Omaha
- Dartmouth-Hitchcock Medical Center
- Albany Medical Center
- Oishei Children's Hospital of Buffalo
- Columbia University Irving Medical Center
- Cohen Children's Medical Center
- Duke University Medical Center; Duke Children's Hospital and Health Center
- Akron Children's Hospital
- Cincinnati Children's Hospital
- Ohio State University College of Medicine; Nationwide Children's Hospital
- Dayton Children's Hospital
- OHSU Doernbecher Children's Hospital
- Women & Infants Hospital of Rhode Island
- Medical University of South Carolina
- Children's Hospital at Erlanger UT Chattanooga
- University of Tennessee Health Science Center; Le Bonheur Children's Hospital
- Monroe Carell Jr. Children's Hospital at Vanderbilt
- University of Texas, Southwestern Medical Center; Children's Medical Center
- Baylor College of Medicine; Texas Children's Hospital
- University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
- Primary Children's Hospital University of Utah
- UVA Children's Hospital
- Virginia Commonwealth University Medical Center; Children's Hospital of Richmond
- University of Washington School of Medicine; Seattle Children's Hospital
- Medical College of Wisconsin; Children's Hospital of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Early inguinal hernia (IH) repair
Late inguinal hernia (IH) repair
Arm Description
IH repair before NICU discharge
IH repair as outpatient at approximately 55-60 weeks post-menstrual age
Outcomes
Primary Outcome Measures
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.
Number of hospital days
Total number of hospital days
Secondary Outcome Measures
Hospital costs
Departmental level costs at each participating institution will be determined for care that occurs from randomization until 9 months post NICU discharge.
Bayley Scales of Infant Development, 3rd Edition
Mean BSID scores; primarily cognitive domain
Full Information
NCT ID
NCT01678638
First Posted
August 30, 2012
Last Updated
October 3, 2023
Sponsor
Vanderbilt University Medical Center
Collaborators
The University of Texas Health Science Center, Houston
1. Study Identification
Unique Protocol Identification Number
NCT01678638
Brief Title
Timing of Inguinal Hernia Repair in Premature Infants
Official Title
Timing of Inguinal Hernia Repair in Premature Infants: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2023 (Actual)
Study Completion Date
September 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
The University of Texas Health Science Center, Houston
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Premature Birth of Newborn
Keywords
inguinal hernia, premature infants, anesthesia safety, neurodevelopmental outcome, preterm infants, neonatal prematurity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
338 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early inguinal hernia (IH) repair
Arm Type
Active Comparator
Arm Description
IH repair before NICU discharge
Arm Title
Late inguinal hernia (IH) repair
Arm Type
Active Comparator
Arm Description
IH repair as outpatient at approximately 55-60 weeks post-menstrual age
Intervention Type
Procedure
Intervention Name(s)
IH repair before NICU discharge
Intervention Description
The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
Intervention Type
Procedure
Intervention Name(s)
IH repair at 55-60 weeks post-menstrual age
Intervention Description
The IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age.
Primary Outcome Measure Information:
Title
Significant adverse event (SAE) rate
Description
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.
Time Frame
9 months beyond NICU discharge
Title
Number of hospital days
Description
Total number of hospital days
Time Frame
From randomization until 9 months post NICU discharge
Secondary Outcome Measure Information:
Title
Hospital costs
Description
Departmental level costs at each participating institution will be determined for care that occurs from randomization until 9 months post NICU discharge.
Time Frame
Enrollment through 9 months after NICU discharge
Title
Bayley Scales of Infant Development, 3rd Edition
Description
Mean BSID scores; primarily cognitive domain
Time Frame
22-26 months corrected age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
37 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin L Blakely, MD, MS
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jon E Tyson, MD, MPH
Organizational Affiliation
University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Arkansas for Medical Sciences; Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Southern California Permanente Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
University of California, Los Angeles David Geffen School of Medicine; Mattel Children's & LA Biomed
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
UCSD Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
UF Health Shands Children's Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Minnesota Medical School; Amplatz Children's Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
SSM Health Cardinal Glennon Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Washington University School of Medicine in St. Louis; St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Children's Hospital & Medical Center of Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Oishei Children's Hospital of Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Columbia University Irving Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cohen Children's Medical Center
City
Queens
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Duke University Medical Center; Duke Children's Hospital and Health Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Cincinnati Children's Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Ohio State University College of Medicine; Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Dayton Children's Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
OHSU Doernbecher Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Women & Infants Hospital of Rhode Island
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Children's Hospital at Erlanger UT Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
University of Tennessee Health Science Center; Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Monroe Carell Jr. Children's Hospital at Vanderbilt
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas, Southwestern Medical Center; Children's Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College of Medicine; Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Primary Children's Hospital University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
UVA Children's Hospital
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Virginia Commonwealth University Medical Center; Children's Hospital of Richmond
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States
Facility Name
University of Washington School of Medicine; Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Medical College of Wisconsin; Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Timing of Inguinal Hernia Repair in Premature Infants
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