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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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

Detailed Summary:
Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Great Ormond Street Hospital for Children NHS Foundation Trust

Dates:
Date Received: April 4, 2011
Date Started: August 2010
Date Completion:
Last Updated: March 1, 2012
Last Verified: March 2012