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
  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

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Estimated Enrollment: 300
Study Start Date: December 2003
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Necrotizing
Enterocolitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014