Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed study, sponsored by NICHD Neonatal Research Network.
NCT01223261 is a clinical trial that has completed, run by NICHD Neonatal Research Network. The registered enrollment target is 156 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Ability to enroll infants in a 1-year period
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2001-03 |
| Est. Completion | 2004-03 |
What the finished NCT01223261 record still lists
NCT01223261 is an observational study that tracks outcomes without assigning an intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01223261 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03082755 · 156 participants · Phase 4
Nighttime Agitation and Restless Legs Syndrome in People With Alzheimer's Disease
- NCT04047628 · 156 participants · Phase 3
Best Available Therapy Versus Autologous Hematopoietic Stem Cell Transplant for Multiple Sclerosis (BEAT-MS)
- NCT04166877 · 156 participants · Phase 4
Magnesium Infusion for Pain Management in Critically Ill Trauma Patients
- NCT04533464 · 156 participants · Phase 2
MultiStem® for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia