Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants

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.

Inclusion Criteria:

- 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 Criteria:

- 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