Necrotizing Enterocolitis (NEC) Surgical Database

• Conditions: Necrotizing Enterocolitis

• Registration Number: NCT00120159
• Lead Sponsor: Boston Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-07-07
• Study First Posted: 2005-07-15
• Status Verified: 2006-01
• Last Update Submitted: 2008-01-14
• Last Update Posted: 2008-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Children's Hospital, Boston; 🇺🇸 Boston, Massachusetts, United States