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Hypothermia for Encephalopathy in Low Income Countries-Feasibilty

NCT01760629 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2015-02-24

No results posted yet for this study

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.

Conditions

  • Neonatal Encephalopathy

Interventions

DEVICE

Tecotherm-HELIX

Whole body cooling using Tecotherm-HELIX

Sponsors & Collaborators

  • Government Medical College, Kozhikode

    collaborator OTHER

  • Institute for Child Health, Madras Medical College, Egmore, Chennai

    collaborator UNKNOWN

  • Wayne State University

    collaborator OTHER

  • Manipal Hospital, India

    collaborator OTHER

  • Thayyil, Sudhin

    lead INDIV

Principal Investigators

  • Sudhin Thayyil, PhD · Imperial College London

  • Seetha Shankaran, MD · Wayne State University, Michigan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Hour
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01760629 on ClinicalTrials.gov