Necrotizing Enterocolitis
Conditions
Keywords
Hypothermia, cooling, necrotizing enterocolitis, NEC, neonates, preterm
Brief summary
Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.
Interventions
PROCEDUREcooling blanket/mattress
Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
PROCEDUREStandard treatment of care at normothermia
Standard treatment of care in 33.5C for 48 hours
Sponsors
Great Ormond Street Hospital for Children NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in sequential organ failure assessment (SOFA) score | 5 days | Difference in sequential organ failure assessment (SOFA) score at 5 days after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
United Kingdom
Outcome results
None listed