Hypothermia for Encephalopathy in Low Income Countries-Feasibilty

Not Applicable

Completed

• Conditions: Neonatal Encephalopathy
• Interventions: Device: Tecotherm-HELIX

• Registration Number: NCT01760629
• Lead Sponsor: Thayyil, Sudhin

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Study Start: 2013-04
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cooling arm	Tecotherm-HELIX	Whole body cooling to 33 to 34 C rectal temperature

Primary Outcome Measures

Name	Time	Method
Feasibility of cooling	72 hours	To examine feasibility of whole body cooling within six hours of birth in infants with neonatal encephalopathy

Secondary Outcome Measures

Name	Time	Method
Short term morbidity	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.

Trial Locations

Locations (3)

Calicut Medical College; 🇮🇳 Calicut, India

Manipal Hospital; 🇮🇳 Bangalore, India

Institute of Child Health, Madras Medical College; 🇮🇳 Chennai, India