Hypothermia for Encephalopathy in Low Income Countries-Feasibilty

Neonatal Encephalopathy Clinical Trial

— HELIX-I  

Official title:

Hypothermia for Encephalopathy in Low Income Countries-Feasibility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760629
• Other study ID #: 3332/002
• Status: Completed
• Phase: N/A
• First received: January 2, 2013
• Last updated: February 20, 2015
• Start date: April 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Thayyil, Sudhin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 1 Month

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Diseases
• Hypothermia
• Neonatal Encephalopathy

Intervention

Device:
• Tecotherm-HELIX
Whole body cooling using Tecotherm-HELIX

Locations

Country	Name	City	State
India	Manipal Hospital	Bangalore
India	Calicut Medical College	Calicut
India	Institute of Child Health, Madras Medical College	Chennai

Sponsors (5)

Lead Sponsor	Collaborator
Thayyil, Sudhin	Calicut Medical College, Calicut, Kerala, India, Institute for Child Health, Madras Medical College, Egmore, Chennai, Manipal Hospital, India, Wayne State University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of cooling	To examine feasibility of whole body cooling within six hours of birth in infants with neonatal encephalopathy	72 hours	No
Secondary	Short term morbidity	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.	2 weeks	No