Status:
TERMINATED
Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants
Lead Sponsor:
Endeavor Health
Collaborating Sponsors:
University of Chicago
Conditions:
Necrotizing Enterocolitis
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
Despite modern medical advances, necrotizing enterocolitis (NEC) remains a significant problem in neonatal intensive care units (ICUs). Although research has shown NEC to be an inflammatory necrosis o...
Detailed Description
Given the extensive inflammatory response inherent to NEC, anti-inflammatory treatment may be of benefit, to both reduce inflammation and as a potential therapy to improve outcome. To date, there is n...
Eligibility Criteria
Inclusion
- Infant born at gestational age less than 34 weeks
- Birth weight less than 2500 grams
- Diagnosis of stage II or III NEC made by attending neonatologist, neonatology fellow, or pediatric hospitalist
- Legally authorized representative is able to provide written informed consent prior to the performance of an protocol-specified evaluations or procedures
- Consent can be obtained and study drug can be administered within 6 hours of diagnosis
Exclusion
- congenital gastrointestinal anomaly
- subject is already receiving parenteral steroid therapy or subject has received parenteral steroids within one week prior to study entry
- subject has received indomethacin therapy within 48 hours prior to being diagnosed with NEC
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01156480
Start Date
September 1 2009
End Date
November 1 2012
Last Update
September 9 2020
Active Locations (2)
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1
University of Chicago Comer Childrens Hospital
Chicago, Illinois, United States
2
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201