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Completed

NCT Number: NCT01678638

Timing of Inguinal Hernia Repair in Premature Infants

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.

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Key information

Conditions

Inguinal Hernia Female Urogenital Diseases and Pregnancy Complications Hernia Hernia, Abdominal Hernia, Inguinal Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Premature Birth of Newborn Urogenital Diseases

Age range

Up to 37 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham School of Medicine; Children's Hospital of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IH repair before NICU discharge

Procedure

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

IH repair at 55-60 weeks post-menstrual age

Procedure

The IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • The University of Texas Health Science Center, Houston

Registry information

Official study title

Timing of Inguinal Hernia Repair in Premature Infants: A Randomized Trial

Important dates

Study start
2013
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2012
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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