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

Primary Purpose

Necrotizing Enterocolitis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
hydrocortisone
placebo
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

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

0 Days - 6 Months (Child)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

hydrocortisone

Placebo

Arm Description

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and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.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.

Outcomes

Primary Outcome Measures

CRP Level
C-reactive protein is a non-specific marker of inflammation, noted to be elevated in infants diagnosed with NEC.
CRP Level
C-reactive protein (CRP) is a non-specific measure of inflammation, usually elevated in infants diagnosed with NEC

Secondary Outcome Measures

Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age)
GI failure
Spontaneous Intestinal Perforation
Whether or not infants had perforation.
Need for Gastrointestinal Surgery
Whether or not the infants required GI surgery by 36 weeks CGA
Incidence of Sepsis
Whether or not enrolled subjects had sepsis before 40 weeks CGA
Time on Parenteral Nutrition
Total time on parenteral nutrition
Time to Full Enteral Feeds
this will be assessed as the time needed to achieve full enteral feeds following the diagnosis of NEC. On average, it will be assessed at 40 weeks CGA, near the time of discharge, but there is a subset of infants who will not yet have achieved full enteral feeds at that time, so it may need to be assessed later than 40 weeks CGA
Length of Stay
this will be assessed at the time of discharge, around 40 weeks CGA on average. A subset of infants may be discharged later than 40 weeks corrected gestational age (CGA), however, so these infants will need to have length of stay assessed later than 40 weeks CGA.
Growth Velocity
Growth velocity after NEC diagnosis, in g/kg/day.
Mortality

Full Information

First Posted
July 1, 2010
Last Updated
August 25, 2020
Sponsor
NorthShore University HealthSystem
Collaborators
University of Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT01156480
Brief Title
Anti-inflammatory Treatment at the Onset of Necrotizing Enterocolitis (NEC) in Preterm Infants
Acronym
steroids/NEC
Official Title
Anti-inflammatory Treatment at the Onset of NEC in Preterm Infants- a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
September 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NorthShore University HealthSystem
Collaborators
University of Chicago

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis
Keywords
necrotizing enterocolitis, NEC, premature, hydrocortisone, steroids, anti-inflammatory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hydrocortisone
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
hydrocortisone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
CRP Level
Description
C-reactive protein is a non-specific marker of inflammation, noted to be elevated in infants diagnosed with NEC.
Time Frame
3 days
Title
CRP Level
Description
C-reactive protein (CRP) is a non-specific measure of inflammation, usually elevated in infants diagnosed with NEC
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Gastrointestinal (GI) Failure (Defined as Not Being on Full Enteral Feeds of 120kcal/kg/Day at 36 Weeks Corrected Age)
Description
GI failure
Time Frame
36 weeks corrected gestational age
Title
Spontaneous Intestinal Perforation
Description
Whether or not infants had perforation.
Time Frame
at 36 weeks corrected gestational age
Title
Need for Gastrointestinal Surgery
Description
Whether or not the infants required GI surgery by 36 weeks CGA
Time Frame
at 36 weeks corrected gestational age
Title
Incidence of Sepsis
Description
Whether or not enrolled subjects had sepsis before 40 weeks CGA
Time Frame
at 40 weeks corrected gestational age
Title
Time on Parenteral Nutrition
Description
Total time on parenteral nutrition
Time Frame
at 40 weeks corrected gestational age
Title
Time to Full Enteral Feeds
Description
this will be assessed as the time needed to achieve full enteral feeds following the diagnosis of NEC. On average, it will be assessed at 40 weeks CGA, near the time of discharge, but there is a subset of infants who will not yet have achieved full enteral feeds at that time, so it may need to be assessed later than 40 weeks CGA
Time Frame
at 40 weeks corrected gestational age
Title
Length of Stay
Description
this will be assessed at the time of discharge, around 40 weeks CGA on average. A subset of infants may be discharged later than 40 weeks corrected gestational age (CGA), however, so these infants will need to have length of stay assessed later than 40 weeks CGA.
Time Frame
at 40 weeks corrected gestational age
Title
Growth Velocity
Description
Growth velocity after NEC diagnosis, in g/kg/day.
Time Frame
at 40 weeks CGA
Title
Mortality
Time Frame
at 40 weeks corrected gestational age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandy L Frost, MD
Organizational Affiliation
NorthShore University HealthSystem
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Comer Childrens Hospital
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
NorthShore University HealthSystem
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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