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

Not Applicable

Terminated

• Conditions: Necrotizing Enterocolitis
• Interventions: Procedure: cooling blanket/mattress; Procedure: Standard treatment of care at normothermia

• Registration Number: NCT01330576
• Lead Sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-02
• Study First Submitted: 2011-04-04
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-07
• Primary Completion: 2013-03-25
• Study Completion: 2013-03-25
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-20
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cooling blanket/mattress	cooling blanket/mattress	Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
Standard treatment of care at normothermia	Standard treatment of care at normothermia	Control group: Standard treatment of care at normothermia

Primary Outcome Measures

Name	Time	Method
Difference in sequential organ failure assessment (SOFA) score	5 days	Difference in sequential organ failure assessment (SOFA) score at 5 days after intervention

Secondary Outcome Measures

Name	Time	Method
Neurodevelopmental Assessment	24 months	Neurodevelopmental outcome with MRI at term corrected age and neurodevelopmental assessment at 3, 6,12 and 24 months and mortality data
Baseline time taken to establish full enteral feeds	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

Trial Locations

Locations (1)

Great Ormond Street Hospital for Children NHS Trust; 🇬🇧 London, United Kingdom