Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants (steroids/NEC)
Necrotizing Enterocolitis
About this trial
This is an interventional treatment trial for Necrotizing Enterocolitis focused on measuring necrotizing enterocolitis, NEC, premature, hydrocortisone, steroids, anti-inflammatory
Eligibility Criteria
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
Sites / Locations
- University of Chicago Comer Childrens Hospital
- NorthShore University HealthSystem
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
hydrocortisone
Placebo
Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.