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Corticosteroid

hydrocortisone for Necrotizing Enterocolitis (steroids/NEC Trial)

N/A
Waitlist Available
Led By Brandy L Frost, MD
Research Sponsored by NorthShore University HealthSystem
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 40 weeks cga
Awards & highlights

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 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.

Eligible Conditions
  • Necrotizing Enterocolitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 40 weeks cga
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 40 weeks cga for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CRP Level
Secondary outcome measures
Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age)
Growth Velocity
Incidence of Sepsis
+6 more

Side effects data

From 2016 Phase 2 trial • 31 Patients • NCT01104025
100%
anemia
97%
fever
23%
hospitalization
16%
hemorrhage
13%
respiratory failure
13%
multiple organ failure
10%
acute kidney injury
10%
hypotension
10%
hypertension
6%
thrombosis
3%
status epilepticus
3%
herpetic keratitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Induction Therapy

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: hydrocortisoneExperimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydrocortisone
FDA approved

Find a Location

Who is running the clinical trial?

NorthShore University HealthSystemLead Sponsor
132 Previous Clinical Trials
737,639 Total Patients Enrolled
University of ChicagoOTHER
1,018 Previous Clinical Trials
734,613 Total Patients Enrolled
Brandy L Frost, MDPrincipal InvestigatorNorthShore University HealthSystem
~0 spots leftby Jul 2025
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