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Necrotizing Enterocolitis (NEC) Surgical Database

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Children's Hospital Boston.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Glaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Yale University
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00120159
First received: June 30, 2005
Last updated: January 14, 2008
Last verified: January 2006

June 30, 2005
January 14, 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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Observational
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.
 
Active, not recruiting
300
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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).
Both
up to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00120159
X03-12-080
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Children's Hospital Boston
  • Glaser Pediatric Research Network
  • Elizabeth Glaser Pediatric AIDS Foundation
  • Yale University
Principal Investigator: Tom Jaskic, MPH, PhD Children's Hospital Boston
Children's Hospital Boston
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP