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

Great Ormond Street Hospital for Children NHS Foundation Trust13 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Necrotizing Enterocolitis

Interventions

cooling blanket/mattressPROCEDURE

Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress

Standard treatment of care at normothermiaPROCEDURE

Standard treatment of care in 33.5C for 48 hours

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Great Ormond Street Hospital for Children NHS Trust

London, United Kingdom

Outcomes

Primary Outcomes

Difference in sequential organ failure assessment (SOFA) score

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

Time frame: 5 days

Secondary Outcomes

Baseline time taken to establish full enteral feeds

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

Time frame: 5 days

Neurodevelopmental Assessment

Neurodevelopmental outcome with MRI at term corrected age and neurodevelopmental assessment at 3, 6,12 and 24 months and mortality data

Time frame: 24 months

Data from ClinicalTrials.gov

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