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Timing of Inguinal Hernia Repair in Premature Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by Martin Blakely, Vanderbilt University
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Martin Blakely, Vanderbilt University Identifier:
First received: August 30, 2012
Last updated: May 12, 2016
Last verified: May 2016
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: 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.

Ages Eligible for Study:   up to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01678638

Contact: Martin L Blakely, MD, MS 6159361050
Contact: Andfrea Krzyzaniak, MA 6159361050 ext 6071

  Show 22 Study Locations
Sponsors and Collaborators
Vanderbilt University
The University of Texas Health Science Center, Houston
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 Identifier: NCT01678638     History of Changes
Other Study ID Numbers: 11-225-01
Study First Received: August 30, 2012
Last Updated: May 12, 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, Inguinal
Pathological Conditions, Anatomical
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Hernia, Abdominal processed this record on May 25, 2017