Timing of Inguinal Hernia Repair in Premature Infants
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Inguinal Hernia
- Premature Birth of Newborn
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Younger than 37 years
- Gender
- Both males and females
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...
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.
Tracking Information
- NCT #
- NCT01678638
- Collaborators
- 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
Get Well Soon