Hypothermia for Encephalopathy in Low Income Countries-Feasibilty (HELIX-I)
Whole body cooling improves survival with normal neurological outcome after neonatal encephalopathy in high-income countries. However, cooling equipments used in the high-income countries are expensive and unsuitable for wider use in low and middle-income countries (LMIC). We had previously conducted a randomised controlled trial of whole body cooling using phase changing material in south India. Although cooling was provided, there were wide temperature fluctuations.
Aim: To examine efficacy of the low technology cooling equipment (Tecotherm-HELIX) in administering effective and stable whole body cooling in encephalopathic infants.
Methods: After informed parental consent (and ethical approvals), we will administer 72 hours of whole body cooling (rectal temperature 33 to 34C) to a total 50 encephalopathic infants (aged <6 hours) admitted to the neonatal units at Calicut Medical College and Madras Medical College, over a six month period. To induce cooling, the infants will be kept on the cooling mattress. Temperature will be continuously measured for 80 hours using a rectal probe connected to a digital data logger.
The primary outcome will be the effective cooling time i.e. percentage of time (95% CI) for which the temperature remains between 33 to 340C during the intended cooling period.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Hypothermia for Encephalopathy in Low Income Countries-Feasibility|
- Feasibility of cooling [ Time Frame: 72 hours ] [ Designated as safety issue: No ]To examine feasibility of whole body cooling within six hours of birth in infants with neonatal encephalopathy
- Short term morbidity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Short-term neonatal morbidity - Hypotension requiring inotropes, cardiac arrhythmias (other than bradycardia), coagulopathy/thrombocytopenia requiring blood products, respiratory failure requiring ventilatory support, seizures, and subcutaneous fat necrosis.
|Study Start Date:||April 2013|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Cooling arm
Whole body cooling to 33 to 34 C rectal temperature
Whole body cooling using Tecotherm-HELIX
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760629
|Calicut Medical College|
|Institute of Child Health, Madras Medical College|
|Principal Investigator:||Sudhin Thayyil, PhD||Imperial College London|
|Principal Investigator:||Seetha Shankaran, MD||Wayne State University, Michigan|