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Timing of Inguinal Hernia Repair in Premature Infants

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01678638
Recruitment Status : Active, not recruiting
First Posted : September 5, 2012
Last Update Posted : May 15, 2023
Sponsor:
Collaborator:
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Martin Blakely, Vanderbilt University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Premature Birth of Newborn Procedure: IH repair before NICU discharge Procedure: IH repair at 55-60 weeks post-menstrual age Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
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
Study Start Date : June 2013
Actual Primary Completion Date : April 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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Arm Intervention/treatment
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 as outpatient at approximately 55-60 weeks post-menstrual age
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Number of hospital days [ Time Frame: From randomization until 9 months post NICU discharge ]
    Total number of hospital days


Secondary Outcome Measures :
  1. 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.

  2. Bayley Scales of Infant Development, 3rd Edition [ Time Frame: 22-26 months corrected age ]
    Mean BSID scores; primarily cognitive domain


Eligibility Criteria
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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 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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Vanderbilt University Medical Center
The University of Texas Health Science Center, Houston
Investigators
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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
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Responsible Party: Martin Blakely, Associate Professor of Pediatric Surgery and Pediatrics, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01678638    
Other Study ID Numbers: 11-225-01
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: May 15, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Martin Blakely, Vanderbilt University Medical Center:
inguinal hernia
premature infants
anesthesia safety
 neurodevelopmental outcome
preterm infants
neonatal prematurity
Additional relevant MeSH terms:
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Premature Birth
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Obstetric Labor, Premature
 Obstetric Labor Complications
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Hernia, Abdominal