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

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ClinicalTrials.gov Identifier: NCT01330576
Recruitment Status : Unknown
Verified March 2012 by Great Ormond Street Hospital for Children NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : April 7, 2011
Last Update Posted : March 2, 2012
Sponsor:
Information provided by:
Great Ormond Street Hospital for Children NHS Foundation Trust

April 4, 2011
April 7, 2011
March 2, 2012
August 2010
August 2013   (Final data collection date for primary outcome measure)
Difference in sequential organ failure assessment (SOFA) score [ Time Frame: 5 days ]
Difference in sequential organ failure assessment (SOFA) score at 5 days after intervention
Same as current
Complete list of historical versions of study NCT01330576 on ClinicalTrials.gov Archive Site
  • Baseline time taken to establish full enteral feeds [ Time Frame: 5 days ]
    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 [ Time Frame: 24 months ]
    Neurodevelopmental outcome with MRI at term corrected age and neurodevelopmental assessment at 3, 6,12 and 24 months and mortality data
Same as current
Not Provided
Not Provided
 
Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Necrotizing Enterocolitis
  • Procedure: cooling blanket/mattress
    Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
  • Procedure: Standard treatment of care at normothermia
    Standard treatment of care in 33.5C for 48 hours
  • Placebo Comparator: Standard treatment of care at normothermia
    Control group: Standard treatment of care at normothermia
    Intervention: Procedure: Standard treatment of care at normothermia
  • Experimental: cooling blanket/mattress
    Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
    Intervention: Procedure: cooling blanket/mattress
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
46
Same as current
Not Provided
August 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01330576
06SG14
No
Not Provided
Not Provided
Research Governance Co-ordinator, Great Ormond Street Hospital for Children NHS Trust
Great Ormond Street Hospital for Children NHS Foundation Trust
Not Provided
Not Provided
Great Ormond Street Hospital for Children NHS Foundation Trust
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP