Expired Study
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Boston, Massachusetts 02115


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.


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).


Study is Available At:


Original ID:

X03-12-080


NCT ID:

NCT00120159


Secondary ID:


Study Acronym:


Brief Title:

Necrotizing Enterocolitis (NEC) Surgical Database


Official Title:

GPRN Neonatal Surgical Database: Necrotizing Enterocolitis (NEC) Protocol


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

2 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Children's Hospital Boston


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Time Perspective: Retrospective


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:

Anticipated


Overall Contact Information

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

Study Dates

Start Date:December 2003
Verification Date:January 2006
Last Changed Date:January 14, 2008
First Received Date:June 30, 2005

Study Outcomes

There are no available Study Outcomes

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Children's Hospital Boston
Agency Class:Other
Agency Type:Collaborator
Agency Name:Glaser Pediatric Research Network

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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