Necrotizing Enterocolitis Clinical Trial
Official title:
Anti-inflammatory Treatment at the Onset of NEC in Preterm Infants- a Pilot Study
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.
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 no specific therapy for NEC that has been found to improve outcome, but
corticosteroids have yet to be investigated in that capacity. Therefore, we propose to
examine the effect of hydrocortisone for treatment of NEC in a randomized, blinded,
placebo-controlled pilot study, focusing on a primary outcome of C-reactive protein levels at
3 and 7 days of therapy as a measure of inflammation. In addition, we will follow several
secondary outcome measures to determine the possibility of improved outcome in those infants
assigned to hydrocortisone.
The investigators hypothesize that infants diagnosed with NEC who receive hydrocortisone will
have significantly lower C-reactive protein levels at 3 and 7 days of treatment versus
infants who receive placebo.
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