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

Further Study Details: 

Expected Total Enrollment:  300

Ages Eligible for Study:  up to  2 Years,  Genders Eligible for Study:  Both

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).

Please refer to this study by ClinicalTrials.gov identifier  NCT00120159

Carol M Sweeney, BS, BSN      617-355-2323    carol.sweeney@childrens.harvard.edu

Massachusetts
      Children''''s Hospital, Boston, Boston,  Massachusetts,  02115,  United States; Recruiting

Study chairs or principal investigators

Tom Jaskic, MPH, PhD,  Principal Investigator,  Children''''s Hospital Boston   

Study ID Numbers:  X03-12-080
Record last reviewed:  June 2005
Last Updated:  July 25, 2005
Record first received:  July 15, 2005
ClinicalTrials.gov Identifier:  NCT00120159
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26