Inguinal Hernia, Premature Birth of Newborn
Conditions
Keywords
inguinal hernia, premature infants, anesthesia safety, neurodevelopmental outcome, preterm infants, neonatal prematurity
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.
Interventions
PROCEDUREIH repair before NICU discharge
The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
PROCEDUREIH repair at 55-60 weeks post-menstrual age
The IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age.
Sponsors
The University of Texas Health Science Center, Houston
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 37 Weeks
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of hospital days | From randomization until 9 months post NICU discharge | Total number of hospital days |
| Significant adverse event (SAE) rate | 9 months beyond NICU discharge | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital costs | Enrollment through 9 months after NICU discharge | 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 | 22-26 months corrected age | Mean BSID scores; primarily cognitive domain |
Countries
United States
Outcome results
None listed