Timing of Inguinal Hernia Repair in Premature Infants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Inguinal Hernia, Premature Birth of Newborn

Intervention / Treatment
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* Procedure: IH repair before NICU discharge
* Procedure: IH repair at 55-60 weeks post-menstrual age


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 37 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early inguinal hernia (IH) repair<br>IH repair before NICU discharge | Procedure: IH repair before NICU discharge<br>* The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)<br>|
| Active Comparator: Late inguinal hernia (IH) repair<br>IH repair as outpatient at approximately 55-60 weeks post-menstrual age | Procedure: IH repair at 55-60 weeks post-menstrual age<br>* The IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of hospital days | Total number of hospital days | From randomization until 9 months post NICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Bayley Scales of Infant Development, 3rd Edition | Mean BSID scores; primarily cognitive domain | 22-26 months corrected age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inguinal hernia, premature infants, anesthesia safety, neurodevelopmental outcome, preterm infants, neonatal prematurity