Necrotizing Enterocolitis (NEC) Surgical Database

Necrotizing Enterocolitis Clinical Trial

Official title:

GPRN Neonatal Surgical Database: Necrotizing Enterocolitis (NEC) Protocol

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00120159
• Other study ID #: X03-12-080
• Status: Active, not recruiting
• Phase: N/A
• First received: June 30, 2005
• Last updated: January 14, 2008
• Start date: December 2003

Study information

• Verified date: January 2006
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The general objectives of this protocol are to develop a multi-center prospective data collection process to identify risk factors for progression of Necrotizing Enterocolitis (NEC). These data will be used as a basis for identifying management strategies appropriate for further evaluation (randomized controlled trials), to develop evidence-based standards of care, and as a tool to facilitate quality-assessment at individual centers through comparison of outcomes with the entire database.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

Patients must meet at least one criterion from each of the following three categories:

Historical Factors:

• Feeding intolerance defined as vomiting of 2 or more feedings within 24 hours or any vomitus containing bile, or the presence of gastric residuals of volume greater than 6cc/kg or any aspirate containing bile

• Apneic/bradycardic episodes

• Oxygen desaturation episode not otherwise explained

• Guaiac positive or grossly bloody stools

Physical Examination Findings:

• Abdominal distention recorded by practitioner

• Capillary refill time greater than 2 seconds

• Abdominal wall discoloration

• Abdominal tenderness

Radiographic Findings:

• Pneumatosis intestinalis

• Portal venous gas

• Ileus

• Dilated bowel

• Pneumoperitoneum

• Air/fluid levels

• Thickened bowel walls

• Ascites or peritoneal fluid

• Free intraperitoneal air

Exclusion Criteria:

Patients will be excluded for any of the following:

• Major gastrointestinal anomaly

• Prior abdominal operation

• Family does not consent to participate (A list of patients for whom consent was refused will be maintained in order to avoid contacting these families repeatedly. All families who refuse consent will be queried as to the reason for refusal).

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Locations

Country	Name	City	State
United States	Children's Hospital, Boston	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
Children's Hospital Boston	Elizabeth Glaser Pediatric AIDS Foundation, Glaser Pediatric Research Network, Yale University

Country where clinical trial is conducted

United States,