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Hypothesis: Controlled hypothermia to 33.5C for 48 hours reduces the severity of critical illness in neonates with severe necrotizing enterocolitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment of care at normothermia | Placebo Comparator | Control group: Standard treatment of care at normothermia |
|
| cooling blanket/mattress | Experimental | Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cooling blanket/mattress | Procedure | Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in sequential organ failure assessment (SOFA) score | Difference in sequential organ failure assessment (SOFA) score at 5 days after intervention | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 days |
| Neurodevelopmental Assessment |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Ormond Street Hospital for Children NHS Trust | London | WC1N 1EH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20100756 | Background | 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. |
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| Standard treatment of care at normothermia | Procedure | Standard treatment of care in 33.5C for 48 hours |
|
Neurodevelopmental outcome with MRI at term corrected age and neurodevelopmental assessment at 3, 6,12 and 24 months and mortality data
| 24 months |
| ID | Term |
|---|---|
| D020345 | Enterocolitis, Necrotizing |
| D007035 | Hypothermia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001513 | Beds |
| ID | Term |
|---|---|
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
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