CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 529 enrolled
Drug / intervention
Laparotomy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01029353
NCT01029353N/ACompleted
CompareCT.gov

A Multi-center Randomized Trial of Laparotomy vs. Drainage as the Initial Surgical Therapy for ELBW Infants With Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP): Outcomes at 18-22 Months Adjusted Age

NICHD Neonatal Research Network·interventional·Posted Dec 10, 2009·Updated Jul 18, 2024

In Brief

A clinical study evaluating Laparotomy and Drainage for Infant, Newborn and 5 related conditions. Completed, enrolled 529 participants across 22 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Enterocolitis, Necrotizing, Intestinal Perforation
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2009
Enrollment StartJan 1, 2010
Primary CompletionAug 1, 2019
TodayJul 1, 2026
Enrollment to primary: 9.6 yearsPosted 16.6 years ago

Interventions

Laparotomyprocedure

Initial laparotomy will be performed. Standard procedures will be used, including inspection of the bowel with removal of diseased areas, creation of stoma(s), and other procedures deemed indicated by the surgeon.

Drainageprocedure

Initial drainage will involve placing a Penrose drain in the abdomen.