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
Recruitment status was Active, not recruiting
Sponsor:
Children's Hospital Boston
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
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Purpose
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 |
|---|
|
Necrotizing Enterocolitis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Retrospective |
| Official Title: | GPRN Neonatal Surgical Database: Necrotizing Enterocolitis (NEC) Protocol |
Further study details as provided by Children's Hospital Boston:
Eligibility| Ages Eligible for Study: | up to 2 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120159
Locations
| United States, Massachusetts | |
| Children's Hospital, Boston | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Children's Hospital Boston
Glaser Pediatric Research Network
Elizabeth Glaser Pediatric AIDS Foundation
Yale University
Investigators
| Principal Investigator: | Tom Jaskic, MPH, PhD | Children's Hospital Boston |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00120159 History of Changes |
| Other Study ID Numbers: | X03-12-080 |
| Study First Received: | June 30, 2005 |
| Last Updated: | January 14, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Children's Hospital Boston:
|
Necrotizing Enterocolitis |
Additional relevant MeSH terms:
|
Enterocolitis Enterocolitis, Necrotizing Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013