Therapeutic Controlled Hypothermia in the Treatment of Neonates With Severe Necrotizing Enterocolitis
NCT ID: NCT01330576
Last Updated: 2022-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
13 participants
INTERVENTIONAL
2010-08-02
2013-03-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard treatment of care at normothermia
Control group: Standard treatment of care at normothermia
Standard treatment of care at normothermia
Standard treatment of care in 33.5C for 48 hours
cooling blanket/mattress
Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
cooling blanket/mattress
Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
Responsible Party
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Locations
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Great Ormond Street Hospital for Children NHS Trust
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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06SG14
Identifier Type: -
Identifier Source: org_study_id
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