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

NCT01156480 | Terminated Results DMC

• 1 other identifier: EH09-196
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Necrotizing Enterocolitis

Keywords

necrotizing enterocolitis; NEC; premature; hydrocortisone; steroids; anti-inflammatory

Outcome Measures

Primary Outcomes (2)

• CRP Level

  C-reactive protein is a non-specific marker of inflammation, noted to be elevated in infants diagnosed with NEC.

  3 days

• CRP Level

  C-reactive protein (CRP) is a non-specific measure of inflammation, usually elevated in infants diagnosed with NEC

  7 days

Secondary Outcomes (9)

• Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age)

  36 weeks corrected gestational age

• Spontaneous Intestinal Perforation

  at 36 weeks corrected gestational age

• Need for Gastrointestinal Surgery

  at 36 weeks corrected gestational age

• Incidence of Sepsis

  at 40 weeks corrected gestational age

• Time on Parenteral Nutrition

  at 40 weeks corrected gestational age

Study Arms (2)

hydrocortisone

EXPERIMENTAL

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.

Drug: hydrocortisone

Placebo

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

hydrocortisone DRUG

Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via 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. 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.

hydrocortisone

placebo DRUG

Subjects in placebo group will receive a volume of placebo equal to the hydrocortisone group, on the same dosing schedule, with doses given every 8 hours via IV route for 3 days, followed by placebo every 8 hours IV for 1 day, followed by placebo every 8 hours IV for 1 day, followed by placebo every 12 hours for 1 day, followed by placebo in single dose for one day. 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.

Placebo

Eligibility Criteria

• Age: 0 Days - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endeavor Health: lead
• University of Chicago: collaborator

Study Sites (2)

University of Chicago Comer Childrens Hospital

Chicago, Illinois, United States

Location

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing; Premature Birth

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Limitations and Caveats

This study was terminated due to low enrollment. We had a drop in our incidence of NEC, so there were very few eligible infants. One subject that was enrolled was soon thereafter thought NOT to have NEC, so that subject never received study drug.

Results Point of Contact

• Title: Dr. Brandy Frost
• Organization: NorthShore University HealthSystem

bfrost@northshore.org

847-570-2033

Study Officials

• Brandy L Frost, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Educator and Attending Neonatologist

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 2, 2010
• Study Start: September 1, 2009
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: September 9, 2020
• Results First Posted: March 24, 2014

Record last verified: 2020-08

Locations

US (2)