Hypothermia for Encephalopathy in Low Income Countries-Feasibilty

Study Overview
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Brief Summary
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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.

Official Title
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Hypothermia for Encephalopathy in Low Income Countries-Feasibility

Conditions
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Neonatal Encephalopathy

Intervention / Treatment
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* Device: Tecotherm-HELIX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age < 6 hours, Birth-weight >1.8, Gestation >36 weeks Need for resuscitation at birth and 5 minute Apgar score <6 (in born babies) or Lack of cry by 5 minutes of age (for out-born babies) Evidence of encephalopathy on clinical examination Exclusion Criteria: Infants in moribound condition, where death is imminent Absent heart rate at 10 minute of age Major life threatening congenital malformation Lack of cooling equipment Lack of parental or physician consent

Ages Eligible for Study
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Minimum Age: 1 Hour
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cooling arm<br>Whole body cooling to 33 to 34 C rectal temperature | Device: Tecotherm-HELIX<br>* Whole body cooling using Tecotherm-HELIX<br>* Other names: Whole body cooling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of cooling | To examine feasibility of whole body cooling within six hours of birth in infants with neonatal encephalopathy | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short term morbidity | 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. | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Encephalopathy, Newborn, Low and Middle-income countries, Hypothermia