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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 529 participants |
| Start Date | 2010-01 |
| Est. Completion | 2019-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗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.
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