Hypothermia for Encephalopathy in Low Income Countries (HELIX)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2013 by Thayyil, Sudhin
Sponsor:
Collaborators:
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
ClinicalTrials.gov Identifier:
NCT01760629
First received: January 2, 2013
Last updated: April 19, 2013
Last verified: April 2013
  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

Resource links provided by NLM:


Further study details as provided by Thayyil, Sudhin:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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:
  • Therapeutic hypothermia
  • Whole body cooling

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01760629

Contacts
Contact: Sudhin Thayyil, PhD 00447912888700 s.thayyil@ucl.ac.uk
Contact: Shreela Pauliah, MRCPCH s.pauliah@ucl.ac.uk

Locations
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         
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
Investigators
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 Diseases
Body Temperature Changes
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014