Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis (CoolNEC)
Primary Purpose
Necrotizing Enterocolitis
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
cooling blanket/mattress
Standard treatment of care at normothermia
Sponsored by
About this trial
This is an interventional treatment trial for Necrotizing Enterocolitis focused on measuring Hypothermia, cooling, necrotizing enterocolitis, NEC, neonates, preterm
Eligibility Criteria
Inclusion Criteria:
- weight at diagnosis > 700 grams
- confirmed NEC (Bell's stage II or III)
- radiological evidence of pneumatosis coli
- systemic compromise as defined by increase in ventilation requirement and/or requiring inotopic support
Sites / Locations
- Great Ormond Street Hospital for Children NHS Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Standard treatment of care at normothermia
cooling blanket/mattress
Arm Description
Control group: Standard treatment of care at normothermia
Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
Outcomes
Primary Outcome Measures
Difference in sequential organ failure assessment (SOFA) score
Difference in sequential organ failure assessment (SOFA) score at 5 days after intervention
Secondary Outcome Measures
Baseline time taken to establish full enteral feeds
Time to establish full enteral feeds and organ functional investigation and biomarkers at baseline, 24 hours post, 63 hours post and day 5 post intervention
Neurodevelopmental Assessment
Neurodevelopmental outcome with MRI at term corrected age and neurodevelopmental assessment at 3, 6,12 and 24 months and mortality data
Full Information
NCT ID
NCT01330576
First Posted
April 4, 2011
Last Updated
January 20, 2022
Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01330576
Brief Title
Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
Acronym
CoolNEC
Official Title
Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
End of funding
Study Start Date
August 2, 2010 (Actual)
Primary Completion Date
March 25, 2013 (Actual)
Study Completion Date
March 25, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Great Ormond Street Hospital for Children NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis
Keywords
Hypothermia, cooling, necrotizing enterocolitis, NEC, neonates, preterm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard treatment of care at normothermia
Arm Type
Placebo Comparator
Arm Description
Control group: Standard treatment of care at normothermia
Arm Title
cooling blanket/mattress
Arm Type
Experimental
Arm Description
Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
Intervention Type
Procedure
Intervention Name(s)
cooling blanket/mattress
Intervention Description
Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
Intervention Type
Procedure
Intervention Name(s)
Standard treatment of care at normothermia
Intervention Description
Standard treatment of care in 33.5C for 48 hours
Primary Outcome Measure Information:
Title
Difference in sequential organ failure assessment (SOFA) score
Description
Difference in sequential organ failure assessment (SOFA) score at 5 days after intervention
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Baseline time taken to establish full enteral feeds
Description
Time to establish full enteral feeds and organ functional investigation and biomarkers at baseline, 24 hours post, 63 hours post and day 5 post intervention
Time Frame
5 days
Title
Neurodevelopmental Assessment
Description
Neurodevelopmental outcome with MRI at term corrected age and neurodevelopmental assessment at 3, 6,12 and 24 months and mortality data
Time Frame
24 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
weight at diagnosis > 700 grams
confirmed NEC (Bell's stage II or III)
radiological evidence of pneumatosis coli
systemic compromise as defined by increase in ventilation requirement and/or requiring inotopic support
Facility Information:
Facility Name
Great Ormond Street Hospital for Children NHS Trust
City
London
ZIP/Postal Code
WC1N 1EH
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
20100756
Citation
Hall NJ, Eaton S, Peters MJ, Hiorns MP, Alexander N, Azzopardi DV, Pierro A. Mild controlled hypothermia in preterm neonates with advanced necrotizing enterocolitis. Pediatrics. 2010 Feb;125(2):e300-8. doi: 10.1542/peds.2008-3211. Epub 2010 Jan 25.
Results Reference
background
Learn more about this trial
Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
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