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ClinicalTrials.gov Identifier: NCT00120159
Verified January 2006 by Boston Children’s Hospital. Recruitment status was: Active, not recruiting
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.
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Ages Eligible for Study:
up to 2 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients must meet at least one criterion from each of the following three categories:
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
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
Portal venous gas
Thickened bowel walls
Ascites or peritoneal fluid
Free intraperitoneal air
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).