Clinical trial NCT01156480: Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants
Official title: Anti-inflammatory Treatment at the Onset of NEC in Preterm Infants- a Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Necrotizing Enterocolitis
Keywords: necrotizing enterocolitis
NEC
premature
hydrocortisone
steroids
anti-inflammatory
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: University of Chicago
First posted: 2010-07-02
Enrollment: 2
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: CRP Level
timeFrame: 3 days
measure: CRP Level
timeFrame: 7 days
Secondary outcomes:
measure: Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age)
timeFrame: 36 weeks corrected gestational age
measure: Spontaneous Intestinal Perforation
timeFrame: at 36 weeks corrected gestational age
measure: Need for Gastrointestinal Surgery
timeFrame: at 36 weeks corrected gestational age
measure: Incidence of Sepsis
timeFrame: at 40 weeks corrected gestational age
measure: Time on Parenteral Nutrition
timeFrame: at 40 weeks corrected gestational age
measure: Time to Full Enteral Feeds
timeFrame: at 40 weeks corrected gestational age
measure: Length of Stay
timeFrame: at 40 weeks corrected gestational age
measure: Growth Velocity
timeFrame: at 40 weeks CGA
measure: Mortality
timeFrame: at 40 weeks corrected gestational age
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Comer Childrens Hospital
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Brandy L Frost, MD
role: PRINCIPAL_INVESTIGATOR
References: