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Timing of Inguinal Hernia Repair in Premature Infants

This study is currently recruiting participants.
Verified May 2016 by Martin Blakely, Vanderbilt University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01678638
First Posted: September 5, 2012
Last Update Posted: May 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Martin Blakely, Vanderbilt University
  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
Intervention Model: Parallel Assignment
Masking: None (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 Martin Blakely, Vanderbilt University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 600
Study Start Date: June 2013
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: July 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 37 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Medical Center
Principal Investigator: Jon E Tyson, MD, MPH University of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
  More Information

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
First Submitted: August 30, 2012
First Posted: September 5, 2012
Last Update Posted: May 13, 2016
Last Verified: May 2016

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

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