Comparison of Two Surgical Treatments for Necrotizing Enterocolitis in Human Infants

Necrotizing Enterocolitis Clinical Trial

Official title:

Surgery for Necrotizing Enterocolitis in Human Infants: A Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00252681
• Other study ID #: RO1 HD38462
• Secondary ID: Gen Clin Res Ctr
• Status: Completed
• Phase: N/A
• First received: November 9, 2005
• Last updated: July 20, 2006
• Start date: July 1999
• Est. completion date: June 2005

Study information

• Verified date: November 2005
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The primary purpose of this study is to compare two surgical treatments for perforated necrotizing enterocolitis in very low birth weight babies.

Description:

This is a multi-center randomized clinical trial comparing laparotomy vs peritoneal drainage for perforated Necrotizing Enterocolitis. The current literature does not allow an objective comparison between these two methods. A recent comprehensive meta-analysis of all published and much unpublished data regarding the use of these procedures in the treatment of perforated NEC revealed that the degree of bias in assignment to treatment precluded an adequate determination as to the best treatment. The conclusion that only a randomized clinical trial would answer this question has led to this multi-center effort. The relative infrequency of the disease at any one neonatal center has necessitated enrollment of patients at many centers.

Comparison: Premature neonates weighing less than 1500 grams at birth who develop perforated necrotizing enterocolitis are randomized within two birth weight blocks (<1000 gms and 1000

• 1499 gms) for treatment with either laparotomy or primary peritoneal drainage. Daily postoperative clinical care is kept uniform between the two groups by means of a critical care pathway. The primary outcome variable is mortality, i.e. death within 90 days of intervention. The main secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Months

Eligibility

Inclusion Criteria:

• Birth weight less than 1500 grams

• Gestational age 24 -33 weeks

• Diagnosed with necrotizing enterocolitis based on Bell stage II or greater

• Bowel perforation as evidenced by free intraperitoneal air seen on abdominal radiograph, stool, bile, or pus found at paracentesis or clinical evidence of perforation in the joint opinion of the attending surgeon and neonatologist.

Exclusion Criteria:

• Bilateral Grade IV intraventricular hemorrhage

• Previous abdominal surgery

• Evidence of gastrointestinal anomaly (i.e. atresia, malrotation etc.)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Procedure:
• laparotomy

• primary peritoneal drainage

Locations

Country	Name	City	State
United States	Yale University School of Medicine Section of Pediatric Surgery	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Moss RL, Dimmitt RA, Barnhart DC, Sylvester KG, Brown RL, Powell DM, Islam S, Langer JC, Sato TT, Brandt ML, Lee H, Blakely ML, Lazar EL, Hirschl RB, Kenney BD, Hackam DJ, Zelterman D, Silverman BL. Laparotomy versus peritoneal drainage for necrotizing en — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome variable is operative mortality, i.e. death within 90 days of intervention.
Secondary	The secondary outcome is short bowel syndrome - defined as the need for chronic parenteral nutrition greater than 3 months following operation.