Hypothermia for Encephalopathy in Low Income Countries-Feasibilty (HELIX-I)
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|ClinicalTrials.gov Identifier: NCT01760629|
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : February 24, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Encephalopathy||Device: Tecotherm-HELIX||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hypothermia for Encephalopathy in Low Income Countries-Feasibility|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Cooling arm
Whole body cooling to 33 to 34 C rectal temperature
Whole body cooling using Tecotherm-HELIX
- Feasibility of cooling [ Time Frame: 72 hours ]To examine feasibility of whole body cooling within six hours of birth in infants with neonatal encephalopathy
- Short term morbidity [ Time Frame: 2 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|