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NCT01223261 · ClinicalTrials.gov registry record
Observational Study of Surgical Treatment of Necrotizing Enterocolotis
A clinical trial, sponsored by NICHD Neonatal Research Network.
- Completed
- Registry status
- 156
- Enrollment target
NCT01223261 is a clinical trial that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 156 participants.
The verdict
NCT01223261 has completed, sponsored by NICHD Neonatal Research Network.
- COMPLETED
- Registry status
- 156 participants
- Enrollment target
Study Summary
The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the ability to distinguish NEC from IP preoperatively and the importance of this distinction on outcome measures; and 3) to evaluate the association between extent of intestinal disease determined at operation and outcome measures. All ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications. Neurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2001-03 |
| Est. Completion | 2004-03 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01223261
The ClinicalTrials.gov registry entry for NCT01223261 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 156 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 0 interventions.
NCT01223261 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01223261 about?
NCT01223261 is a clinical study titled "Observational Study of Surgical Treatment of Necrotizing Enterocolotis". The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the ability to distinguish NEC...
What is the current status of trial NCT01223261?
This trial is currently completed. The enrollment target is 156 participants. The study started on 2001-03. Estimated completion is 2004-03.
Who is sponsoring clinical trial NCT01223261?
This trial is sponsored by NICHD Neonatal Research Network, which has 61 total clinical trials registered on ClinicalTrials.gov.
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