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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: Completed NA study, sponsored by NICHD Neonatal Research Network.
NCT01029353 is a NA study that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 529 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Death or NDI 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 |
What the finished NCT01029353 record still lists
NCT01029353 is an interventional study that assigns participants to a tested intervention. The registered 529 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 (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Laparotomy is the first listed.
NCT01029353 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01029353's enrollment target sits among peer trials
529 188th of 2000 higher than 1,813 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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