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NCT01678638 · ClinicalTrials.gov registry record · NA

Timing of Inguinal Hernia Repair in Premature Infants

A NA study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
NA
Development phase
338
Enrollment target

NCT01678638: Completed NA study, sponsored by Vanderbilt University Medical Center.

NCT01678638 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 338 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01678638, a NA study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
NA
Development phase
338 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • PROCEDURE IH repair before NICU discharge
  • PROCEDURE IH repair at 55-60 weeks post-menstrual age

Trial Details

FieldValue
Enrollment Target 338 participants
Start Date 2013-06
Est. Completion 2023-09
Phase NA

What the finished NCT01678638 record still lists

NCT01678638 is an interventional study that assigns participants to a tested intervention. The registered 338 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (76% lower).

The record links to 0 conditions, and to 2 interventions - of which IH repair before NICU discharge is the first listed.

NCT01678638 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01678638 about?

NCT01678638 is a clinical study titled "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.

What is the current status of trial NCT01678638?

This trial is currently completed. It is a NA study. The enrollment target is 338 participants. The study started on 2013-06. Estimated completion is 2023-09.

What interventions are being tested in trial NCT01678638?

The interventions under investigation include: IH repair before NICU discharge (PROCEDURE), IH repair at 55-60 weeks post-menstrual age (PROCEDURE).

Who is sponsoring clinical trial NCT01678638?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01678638's enrollment target sits among peer trials

338 305th of 2000 higher than 1,696 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01678638, the US trial registry maintained by the National Library of Medicine. NCT01678638 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.