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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
338
The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
The IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age.
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.
Time frame: 9 months beyond NICU discharge
Number of hospital days
Total number of hospital days
Time frame: From randomization until 9 months post NICU discharge
Hospital costs
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
Bayley Scales of Infant Development, 3rd Edition
Mean BSID scores; primarily cognitive domain
Time frame: 22-26 months corrected age
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University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama
Birmingham, Alabama, 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
Naval Medical Center San Diego
San Diego, California, United States
UCSD Rady Children's Hospital
San Diego, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
UF Health Shands Children's Hospital
Gainesville, Florida, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
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