Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants
Stopped early · Not applicable · Has a placebo group
Conditions studied: Necrotizing Enterocolitis
In brief
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 of the bowels, to date no study has examined the effect of anti-inflammatory therapy on this dreaded disease once it is diagnosed. The investigators propose a multi-center, randomized, placebo-controlled, double-blinded pilot study to examine the effect of hydrocortisone in infants diagnosed with stages II and III NEC. The investigators will follow C-reactive protein (CRP) levels as a marker of systemic inflammation for the primary outcome in this study.
Key facts
- Study ID
- NCT01156480
- Run by
- Endeavor Health
- People needed
- 2
- Starts
- 2009-09-01
- Expected to finish
- 2012-11-01
- Last updated by the study team
- 2020-09-09
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Chicago Comer Childrens Hospital — Chicago, Illinois, United States
- NorthShore University HealthSystem — Evanston, Illinois, United States
Full record on ClinicalTrials.gov
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