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Timing of Inguinal Hernia Repair in Premature Infants

N/A
Waitlist Available
Led By Martin L Blakely, MD, MS
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22-26 months corrected age
Awards & highlights
No Placebo-Only Group

Summary

This trial will help determine whether it is safer to repair an inguinal hernia before an infant is discharged from the NICU or later on, when the baby is around 55-60 weeks old.

Eligible Conditions
  • Preterm Birth
  • Inguinal Hernia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22-26 months corrected age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 22-26 months corrected age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of hospital days
Significant adverse event (SAE) rate
Secondary study objectives
Bayley Scales of Infant Development, 3rd Edition
Hospital costs

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: Early inguinal hernia (IH) repairActive Control1 Intervention
IH repair before NICU discharge
Group II: Late inguinal hernia (IH) repairActive Control1 Intervention
IH repair as outpatient at approximately 55-60 weeks post-menstrual age

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
904 Previous Clinical Trials
933,741 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
957 Previous Clinical Trials
347,784 Total Patients Enrolled
Martin L Blakely, MD, MSPrincipal InvestigatorVanderbilt University Medical Center
Jon E Tyson, MD, MPHPrincipal InvestigatorUniversity of Texas Health Science Center at Houston; Children's Memorial Hermann Hospital
3 Previous Clinical Trials
68,968 Total Patients Enrolled
~27 spots leftby Dec 2025
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