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Hypothermia for Encephalopathy in Low Income Countries-Feasibilty (HELIX-I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01760629
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : February 24, 2015
Government Medical College, Kozhikode
Institute for Child Health, Madras Medical College, Egmore, Chennai
Wayne State University
Manipal Hospital, India
Information provided by (Responsible Party):
Thayyil, Sudhin

Brief 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.

Condition or disease Intervention/treatment Phase
Neonatal Encephalopathy Device: Tecotherm-HELIX Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: Cooling arm
Whole body cooling to 33 to 34 C rectal temperature
Device: Tecotherm-HELIX
Whole body cooling using Tecotherm-HELIX
Other Names:
  • Therapeutic hypothermia
  • Whole body cooling

Primary Outcome Measures :
  1. Feasibility of cooling [ Time Frame: 72 hours ]
    To examine feasibility of whole body cooling within six hours of birth in infants with neonatal encephalopathy

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age < 6 hours, Birth-weight >1.8, Gestation >36 weeks
  2. 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)
  3. 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01760629

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Manipal Hospital
Bangalore, India
Calicut Medical College
Calicut, India
Institute of Child Health, Madras Medical College
Chennai, India
Sponsors and Collaborators
Thayyil, Sudhin
Government Medical College, Kozhikode
Institute for Child Health, Madras Medical College, Egmore, Chennai
Wayne State University
Manipal Hospital, India
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Principal Investigator: Sudhin Thayyil, PhD Imperial College London
Principal Investigator: Seetha Shankaran, MD Wayne State University, Michigan
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Thayyil, Sudhin Identifier: NCT01760629    
Other Study ID Numbers: 3332/002
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: February 24, 2015
Last Verified: February 2015
Keywords provided by Thayyil, Sudhin:
Encephalopathy, Newborn, Low and Middle-income countries, Hypothermia
Additional relevant MeSH terms:
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Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Body Temperature Changes