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NCT01330576 Clinical Trial

Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis

Necrotizing Enterocolitis Clinical Trial

— CoolNEC  

Official title:
Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01330576
Other study ID # 06SG14
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 2, 2010
Est. completion date March 25, 2013

Study information
Verified date January 2022
Source Great Ormond Street Hospital for Children NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.

Recruitment information / eligibility
Status Terminated
Enrollment 13
Est. completion date March 25, 2013
Est. primary completion date March 25, 2013
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• cooling blanket/mattress
Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
• Standard treatment of care at normothermia
Standard treatment of care in 33.5C for 48 hours

Locations
Country Name City State
United Kingdom Great Ormond Street Hospital for Children NHS Trust London

Sponsors (1)
Lead Sponsor Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in sequential organ failure assessment (SOFA) score Difference in sequential organ failure assessment (SOFA) score at 5 days after intervention 5 days
Secondary 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 5 days
Secondary Neurodevelopmental Assessment Neurodevelopmental outcome with MRI at term corrected age and neurodevelopmental assessment at 3, 6,12 and 24 months and mortality data 24 months
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