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

This study is currently recruiting participants.
Verified March 2012 by Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor:
Information provided by:
Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01330576
First received: April 4, 2011
Last updated: March 1, 2012
Last verified: March 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Necrotizing Enterocolitis
 Procedure: cooling blanket/mattress
Procedure: Standard treatment of care at normothermia
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Further study details as provided by Great Ormond Street Hospital for Children NHS Foundation Trust:

Primary Outcome Measures:
  • Difference in sequential organ failure assessment (SOFA) score [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    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 Frame: 5 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Neurodevelopmental outcome with MRI at term corrected age and neurodevelopmental assessment at 3, 6,12 and 24 months and mortality data


Estimated Enrollment: 46
Study Start Date: August 2010
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Standard treatment of care at normothermia
Control group: Standard treatment of care at normothermia
 Procedure: Standard treatment of care at normothermia
Standard treatment of care in 33.5C for 48 hours
Experimental: cooling blanket/mattress
Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
 Procedure: cooling blanket/mattress
Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330576

Locations
United Kingdom
Great Ormond Street Hospital for Children NHS Trust Recruiting
London, United Kingdom, WC1N 1EH
Contact: Agostino Pierro, Professor         a.pierro@ich.ucl.ac.uk    
Principal Investigator: Nurain Sim, Dr            
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
  More Information

Publications:

Responsible Party: Research Governance Co-ordinator, Great Ormond Street Hospital for Children NHS Trust
ClinicalTrials.gov Identifier: NCT01330576     History of Changes
Other Study ID Numbers: 06SG14
Study First Received: April 4, 2011
Last Updated: March 1, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust:
Hypothermia
cooling
necrotizing enterocolitis
 NEC
neonates
preterm

Additional relevant MeSH terms:
Enterocolitis
Hypothermia
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Diseases
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013