Hypothermia for Encephalopathy in Low Income Countries (HELIX)
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Purpose
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 | Intervention |
|---|---|
|
Neonatal Encephalopathy |
Device: Tecotherm-HELIX |
| Study Type: | Interventional |
| 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 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.
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cooling arm
Whole body cooling to 33 to 34 C rectal temperature
|
Device: Tecotherm-HELIX
Whole body cooling using Tecotherm-HELIX
Other Names:
|
Eligibility| Ages Eligible for Study: | up to 1 Month |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Sudhin Thayyil, PhD | 00447912888700 | s.thayyil@ucl.ac.uk |
| Contact: Shreela Pauliah, MRCPCH | s.pauliah@ucl.ac.uk |
| India | |
| Manipal Hospital | Active, not recruiting |
| Bangalore, India | |
| Calicut Medical College | Not yet recruiting |
| Calicut, India | |
| Principal Investigator: Vijayakumar Madhavan, MD | |
| Sub-Investigator: Mohandas Nair, MD | |
| Sub-Investigator: Gireesh S, MD | |
| Institute of Child Health, Madras Medical College | Not yet recruiting |
| Chennai, India | |
| Principal Investigator: Kumutha Kumaraswami, MD | |
| Sub-Investigator: Narayanan E, MD | |
| Principal Investigator: | Sudhin Thayyil, PhD | University College, London |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University, Michigan |
More Information
No publications provided
| Responsible Party: | Thayyil, Sudhin |
| ClinicalTrials.gov Identifier: | NCT01760629 History of Changes |
| Other Study ID Numbers: | 3332/002 |
| Study First Received: | January 2, 2013 |
| Last Updated: | April 19, 2013 |
| Health Authority: | UK: Research Ethics Committee |
Keywords provided by Thayyil, Sudhin:
|
Encephalopathy, Newborn, Low and Middle-income countries, Hypothermia |
Additional relevant MeSH terms:
|
Hypothermia Brain Damage, Chronic Delirium Encephalitis Hepatic Encephalopathy Neurotoxicity Syndromes Body Temperature Changes Signs and Symptoms Brain Diseases Central Nervous System Diseases Nervous System Diseases Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Liver Failure Hepatic Insufficiency Liver Diseases Digestive System Diseases Brain Diseases, Metabolic Metabolic Diseases Poisoning Substance-Related Disorders |
ClinicalTrials.gov processed this record on May 19, 2013