Timing of Inguinal Hernia Repair in Premature Infants

• ClinicalTrials.gov Identifier: NCT01678638
• Recruitment Status: Completed
• First Posted: September 5, 2012
• Last Update Posted: October 4, 2023
• Sponsor: Vanderbilt University Medical Center
• Collaborator: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): Martin Blakely, Vanderbilt University Medical Center

Tracking Information

• First Submitted Date: August 30, 2012
• First Posted Date: September 5, 2012
• Last Update Posted Date: October 4, 2023
• Study Start Date: June 2013
• Actual Primary Completion Date: April 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 4, 2012)

• Significant adverse event (SAE) rate [ Time Frame: 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.
• Number of hospital days [ Time Frame: From randomization until 9 months post NICU discharge ]
  Total number of hospital days

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 4, 2012)

• Hospital costs [ Time Frame: 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 [ Time Frame: 22-26 months corrected age ]
  Mean BSID scores; primarily cognitive domain

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Timing of Inguinal Hernia Repair in Premature Infants
• Official Title: Timing of Inguinal Hernia Repair in Premature Infants: A Randomized Trial
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Inguinal Hernia
• Premature Birth of Newborn

Intervention

• Procedure: IH repair before NICU discharge
  The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
• Procedure: IH 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.

Study Arms

• Active Comparator: Early inguinal hernia (IH) repair
  IH repair before NICU discharge
  Intervention: Procedure: IH repair before NICU discharge
• Active Comparator: Late inguinal hernia (IH) repair
  IH repair as outpatient at approximately 55-60 weeks post-menstrual age
  Intervention: Procedure: IH repair at 55-60 weeks post-menstrual age

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 3, 2023): 338
• Original Estimated Enrollment (submitted: September 4, 2012): 600
• Actual Study Completion Date: September 2023
• Actual Primary Completion Date: April 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 37 Weeks (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01678638
• Other Study ID Numbers: 11-225-01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Martin Blakely, Vanderbilt University Medical Center
• Original Responsible Party: Martin Blakely, Vanderbilt University, Associate Professor of Pediatric Surgery and Pediatrics
• Current Study Sponsor: Vanderbilt University Medical Center
• Original Study Sponsor: Vanderbilt University
• Collaborators: The University of Texas Health Science Center, Houston

Investigators

• Principal Investigator: Martin L Blakely, MD, MS; Vanderbilt University Medical Center
• Principal Investigator: Jon E Tyson, MD, MPH; University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital

• PRS Account: Vanderbilt University Medical Center
• Verification Date: October 2023