Timing of Inguinal Hernia Repair in Premature Infants
Purpose
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.
Conditions
- Inguinal Hernia
- Premature Birth of Newborn
Eligibility
- Eligible Ages
- Under 37 Weeks
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Active Comparator Early inguinal hernia (IH) repair |
IH repair before NICU discharge |
|
Active Comparator Late inguinal hernia (IH) repair |
IH repair as outpatient at approximately 55-60 weeks post-menstrual age |
|
More Details
- Status
- Completed
- Sponsor
- Vanderbilt University Medical Center
Study Contact
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.