Timing of Inguinal Hernia Repair in Premature Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Vanderbilt University
Sponsor:
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Martin Blakely, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01678638
First received: August 30, 2012
Last updated: May 26, 2015
Last verified: May 2015
  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.


Condition Intervention
Inguinal Hernia
Premature Birth of Newborn
Procedure: IH repair before NICU discharge
Procedure: IH repair at 55-60 weeks post-menstrual age

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Timing of Inguinal Hernia Repair in Premature Infants: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Significant adverse event (SAE) rate [ Time Frame: 9 months beyond NICU discharge ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Total number of hospital days


Secondary Outcome Measures:
  • Hospital costs [ Time Frame: Enrollment through 9 months after NICU discharge ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Mean BSID scores; primarily cognitive domain


Estimated Enrollment: 600
Study Start Date: June 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early inguinal hernia (IH) repair
IH repair before NICU discharge
Procedure: IH repair before NICU discharge
The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
Active Comparator: Late inguinal hernia (IH) repair
IH repair at 55-60 weeks post-menstrual age
Procedure: IH repair at 55-60 weeks post-menstrual age
The IH repair will be performed between 55-60 weeks post-menstrual age.

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.

  Eligibility

Ages Eligible for Study:   up to 37 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infant with estimated gestational age < 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 impact neurodevelopmental outcome or chromosomal abnormality
  • Family unable / unwilling to return for follow up and later IH repair; or likely unable to monitor IH as outpatient
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01678638

Contacts
Contact: Martin L Blakely, MD, MS 6159361050 martin.blakely@vanderbilt.edu
Contact: Andfrea Krzyzaniak, MA 6159361050 ext 6071 andrea.krzyzaniak@vanderbilt.edu

  Show 22 Study Locations
Sponsors and Collaborators
Vanderbilt University
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Martin L Blakely, MD, MS Vanderbilt University
Principal Investigator: Jon E Tyson, MD, MPH University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
  More Information

No publications provided

Responsible Party: Martin Blakely, Associate Professor of Pediatric Surgery and Pediatrics, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01678638     History of Changes
Other Study ID Numbers: 11-225-01
Study First Received: August 30, 2012
Last Updated: May 26, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
inguinal hernia
premature infants
anesthesia safety
neurodevelopmental outcome
preterm infants
neonatal prematurity

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Premature Birth
Hernia, Abdominal
Obstetric Labor Complications
Obstetric Labor, Premature
Pathological Conditions, Anatomical
Pregnancy Complications

ClinicalTrials.gov processed this record on June 28, 2015