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

Thayyil, Sudhin

Status: Completed

Conditions: Neonatal Encephalopathy

Treatments: Device: Tecotherm-HELIX

Study type: Interventional

Funder types: Other

Identifiers

NCT01760629

3332/002

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 1 hour to 1 month old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

Cooling arm

Experimental group

Description:

Whole body cooling to 33 to 34 C rectal temperature

Treatment:

Device: Tecotherm-HELIX