Viewing Study NCT00120159


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Study NCT ID: NCT00120159
Status: UNKNOWN
Last Update Posted: 2008-01-15
First Post: 2005-06-30
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Necrotizing Enterocolitis (NEC) Surgical Database
Sponsor: Boston Children's Hospital
Organization:

Study Overview

Official Title: GPRN Neonatal Surgical Database: Necrotizing Enterocolitis (NEC) Protocol
Status: UNKNOWN
Status Verified Date: 2006-01
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.
Detailed Description: None

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: