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Sponsors and Collaborators: |
Children's Hospital Boston Glaser Pediatric Research Network Elizabeth Glaser Pediatric AIDS Foundation Yale University |
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Information provided by: | Children's Hospital Boston |
ClinicalTrials.gov Identifier: | NCT00120159 |
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.
Condition |
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Necrotizing Enterocolitis |
Study Type: | Observational |
Study Design: | Retrospective |
Official Title: | GPRN Neonatal Surgical Database: Necrotizing Enterocolitis (NEC) Protocol |
Ages Eligible for Study: | up to 2 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must meet at least one criterion from each of the following three categories:
Historical Factors:
Physical Examination Findings:
Radiographic Findings:
Exclusion Criteria:
Patients will be excluded for any of the following:
United States, Massachusetts | |
Children's Hospital, Boston | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Tom Jaskic, MPH, PhD | Children's Hospital Boston |
Study ID Numbers: | X03-12-080 |
Study First Received: | June 30, 2005 |
Last Updated: | January 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00120159 |
Health Authority: | United States: Institutional Review Board |
Necrotizing Enterocolitis |
Digestive System Diseases Gastrointestinal Diseases Necrotizing enterocolitis Intestinal Diseases |
Gastroenteritis Enterocolitis, Necrotizing Enterocolitis |