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Completed

NCT Number: NCT01760629

Hypothermia for Encephalopathy in Low Income Countries-Feasibilty

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.

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Key information

Conditions

Neonatal Encephalopathy Body Temperature Changes Brain Diseases Central Nervous System Diseases Hypothermia Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 hour–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manipal Hospital, Bangalore, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tecotherm-HELIX

Device

Whole body cooling using Tecotherm-HELIX

Other names: Therapeutic hypothermia, Whole body cooling

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Thayyil, Sudhin

Indiv

Collaborators

  • Government Medical College, Kozhikode
  • Institute for Child Health, Madras Medical College, Egmore, Chennai
  • Manipal Hospital, India
  • Wayne State University

Registry information

Official study title

Hypothermia for Encephalopathy in Low Income Countries-Feasibility

Acronym: HELIX-I

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 4, 2013
Registry last updated
Feb 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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