Status:
UNKNOWN
Necrotizing Enterocolitis (NEC) Surgical Database
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Glaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Conditions:
Necrotizing Enterocolitis
Eligibility:
All Genders
1-2 years
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 b...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00120159
Start Date
December 1 2003
Last Update
January 15 2008
Active Locations (1)
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1
Children's Hospital, Boston
Boston, Massachusetts, United States, 02115