NCT01760629

Hypothermia for Encephalopathy in Low Income Countries-Feasibilty

Hypothermia for Encephalopathy in Low Income Countries-Feasibility

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Thayyil, Sudhin · Individual
• Sex: All
• Age: 1 Hour – 1 Month
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Neonatal Encephalopathy

Interventions

Type	Name	Description
DEVICE	Tecotherm-HELIX	Whole body cooling using Tecotherm-HELIX

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-01-04
• Last updated: 2015-02-24

Locations

3 sites across 1 country: India