Hypothermia for Encephalopathy in Low Income Countries-Feasibilty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Neonatal Encephalopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cooling arm

Whole body cooling to 33 to 34 C rectal temperature

Group Type EXPERIMENTAL

Tecotherm-HELIX

Intervention Type DEVICE

Whole body cooling using Tecotherm-HELIX

Interventions

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Tecotherm-HELIX

Whole body cooling using Tecotherm-HELIX

Intervention Type DEVICE

Other Intervention Names

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Therapeutic hypothermia Whole body cooling

Eligibility Criteria

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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

Minimum Eligible Age

1 Hour

Maximum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No