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NCT01029353 · ClinicalTrials.gov registry record · NA

Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis

A NA study, sponsored by NICHD Neonatal Research Network.

Completed
Registry status
NA
Development phase
529
Enrollment target

NCT01029353 is a NA study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 529 participants.

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The verdict

NCT01029353, a NA study, has completed, sponsored by NICHD Neonatal Research Network.

COMPLETED
Registry status
NA
Development phase
529 participants
Enrollment target

Study Summary

This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed with NEC or IP requiring surgical intervention, will be recruited. Subjects will be randomized to receive either a laparotomy or peritoneal drainage. Primary outcome is impairment-free survival at 18-22 months corrected age.

Interventions

  • PROCEDURE Laparotomy
  • PROCEDURE Drainage

Trial Details

FieldValue
Enrollment Target 529 participants
Start Date 2010-01
Est. Completion 2019-08
Phase NA

Sponsor

NICHD Neonatal Research Network

61 total trials

What the Registry Record Tells You About NCT01029353

The ClinicalTrials.gov registry entry for NCT01029353 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 529 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NICHD Neonatal Research Network, which has 61 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Laparotomy is the first listed.

NCT01029353 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01029353 about?

NCT01029353 is a clinical study titled "Laparotomy vs. Drainage for Infants With Necrotizing Enterocolitis". This study will compare the effectiveness of two surgical procedures -laparotomy versus drainage - commonly used to treat necrotizing enterocolitis (NEC) or isolated intestinal perforations (IP) in extremely low birth weight infants (≤1,000 g). Infants diagnosed with NEC or IP requiring surgical int...

What is the current status of trial NCT01029353?

This trial is currently completed. It is a NA study. The enrollment target is 529 participants. The study started on 2010-01. Estimated completion is 2019-08.

What interventions are being tested in trial NCT01029353?

The interventions under investigation include: Laparotomy (PROCEDURE), Drainage (PROCEDURE).

Who is sponsoring clinical trial NCT01029353?

This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.