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Necrotizing Enterocolitis (NEC) Surgical Database

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ClinicalTrials.gov Identifier: NCT00120159
Recruitment Status : Unknown
Verified January 2006 by Boston Children’s Hospital.
Recruitment status was:  Active, not recruiting
First Posted : July 15, 2005
Last Update Posted : January 15, 2008
Glaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Yale University
Information provided by:
Boston Children’s Hospital

June 30, 2005
July 15, 2005
January 15, 2008
December 2003
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Complete list of historical versions of study NCT00120159 on ClinicalTrials.gov Archive Site
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Necrotizing Enterocolitis (NEC) Surgical Database
GPRN Neonatal Surgical Database: Necrotizing Enterocolitis (NEC) Protocol
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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Time Perspective: Retrospective
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Necrotizing Enterocolitis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
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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).
Sexes Eligible for Study: All
up to 2 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
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Boston Children’s Hospital
  • Glaser Pediatric Research Network
  • Elizabeth Glaser Pediatric AIDS Foundation
  • Yale University
Principal Investigator: Tom Jaskic, MPH, PhD Boston Children’s Hospital
Boston Children’s Hospital
January 2006