Clinical trial NCT01678638: Timing of Inguinal Hernia Repair in Premature Infants
Official title: Timing of Inguinal Hernia Repair in Premature Infants: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Premature Birth of Newborn
Keywords: inguinal hernia
premature infants
anesthesia safety
neurodevelopmental outcome
preterm infants
neonatal prematurity
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
First posted: 2012-09-05
Enrollment: 338
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Significant adverse event (SAE) rate
timeFrame: 9 months beyond NICU discharge
measure: Number of hospital days
timeFrame: From randomization until 9 months post NICU discharge
Secondary outcomes:
measure: Hospital costs
timeFrame: Enrollment through 9 months after NICU discharge
measure: Bayley Scales of Infant Development, 3rd Edition
timeFrame: 22-26 months corrected age
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama
state: Alabama
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences; Arkansas Children's Hospital
state: Arkansas
city: Los Angeles
country: United States
facility: Southern California Permanente Group
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles David Geffen School of Medicine; Mattel Children's & LA Biomed
state: California
city: Madera
country: United States
facility: Valley Children's Hospital
state: California
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
city: San Diego
country: United States
facility: UCSD Rady Children's Hospital
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Gainesville
country: United States
facility: UF Health Shands Children's Hospital
state: Florida
city: Saint Petersburg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Medical School; Amplatz Children's Hospital
state: Minnesota
city: Saint Louis
country: United States
facility: SSM Health Cardinal Glennon Children's Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis; St. Louis Children's Hospital
state: Missouri
city: Omaha
country: United States
facility: Children's Hospital & Medical Center of Omaha
state: Nebraska
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Buffalo
country: United States
facility: Oishei Children's Hospital of Buffalo
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
city: Queens
country: United States
facility: Cohen Children's Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center; Duke Children's Hospital and Health Center
state: North Carolina
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Columbus
country: United States
facility: Ohio State University College of Medicine; Nationwide Children's Hospital
state: Ohio
city: Dayton
country: United States
facility: Dayton Children's Hospital
state: Ohio
city: Portland
country: United States
facility: OHSU Doernbecher Children's Hospital
state: Oregon
city: Providence
country: United States
facility: Women & Infants Hospital of Rhode Island
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Chattanooga
country: United States
facility: Children's Hospital at Erlanger UT Chattanooga
state: Tennessee
city: Memphis
country: United States
facility: University of Tennessee Health Science Center; Le Bonheur Children's Hospital
state: Tennessee
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital at Vanderbilt
state: Tennessee
city: Dallas
country: United States
facility: University of Texas, Southwestern Medical Center; Children's Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine; Texas Children's Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Hospital University of Utah
state: Utah
city: Charlottesville
country: United States
facility: UVA Children's Hospital
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center; Children's Hospital of Richmond
state: Virginia
city: Seattle
country: United States
facility: University of Washington School of Medicine; Seattle Children's Hospital
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin; Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Vanderbilt University Medical Center
name: Martin L Blakely, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
name: Jon E Tyson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: