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

This study has been completed.
Calicut Medical College, Calicut, Kerala, India
Institute for Child Health, Madras Medical College, Egmore, Chennai
Wayne State University
Manipal Hospital, India
Information provided by (Responsible Party):
Thayyil, Sudhin Identifier:
First received: January 2, 2013
Last updated: February 20, 2015
Last verified: February 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 Intervention
Neonatal Encephalopathy Device: Tecotherm-HELIX

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hypothermia for Encephalopathy in Low Income Countries-Feasibility

Resource links provided by NLM:

Further study details as provided by Thayyil, Sudhin:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 62
Study Start Date: April 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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:
  • Therapeutic hypothermia
  • Whole body cooling


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01760629

Manipal Hospital
Bangalore, India
Calicut Medical College
Calicut, India
Institute of Child Health, Madras Medical College
Chennai, India
Sponsors and Collaborators
Thayyil, Sudhin
Calicut Medical College, Calicut, Kerala, India
Institute for Child Health, Madras Medical College, Egmore, Chennai
Wayne State University
Manipal Hospital, India
Principal Investigator: Sudhin Thayyil, PhD Imperial College London
Principal Investigator: Seetha Shankaran, MD Wayne State University, Michigan
  More Information

Responsible Party: Thayyil, Sudhin Identifier: NCT01760629     History of Changes
Other Study ID Numbers: 3332/002
Study First Received: January 2, 2013
Last Updated: February 20, 2015

Keywords provided by Thayyil, Sudhin:
Encephalopathy, Newborn, Low and Middle-income countries, Hypothermia

Additional relevant MeSH terms:
Brain Diseases
Body Temperature Changes
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases processed this record on September 20, 2017