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

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ClinicalTrials.gov Identifier: NCT01760629
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : February 24, 2015
Sponsor:
Collaborators:
Government Medical College, Kozhikode
Institute for Child Health, Madras Medical College, Egmore, Chennai
Wayne State University
Manipal Hospital, India
Information provided by (Responsible Party):
Thayyil, Sudhin

Tracking Information
First Submitted Date  ICMJE January 2, 2013
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date February 24, 2015
Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
Feasibility of cooling [ Time Frame: 72 hours ]
To examine feasibility of whole body cooling within six hours of birth in infants with neonatal encephalopathy
Original Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
Effective cooling time [ Time Frame: 72 hours ]
The primary outcome will be the effective cooling time i.e. percentage of time (95% CI) for which the temperature remains between 33 to 34 C during the intended cooling period.
Change History Complete list of historical versions of study NCT01760629 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2013)
Short term morbidity [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
Passive re-warming time [ Time Frame: 4 days ]
Time taken to achieve 3 consecutive temperatures >36.5 after completion of cooling
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypothermia for Encephalopathy in Low Income Countries-Feasibilty
Official Title  ICMJE Hypothermia for Encephalopathy in Low Income Countries-Feasibility
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neonatal Encephalopathy
Intervention  ICMJE Device: Tecotherm-HELIX
Whole body cooling using Tecotherm-HELIX
Other Names:
  • Therapeutic hypothermia
  • Whole body cooling
Study Arms  ICMJE Experimental: Cooling arm
Whole body cooling to 33 to 34 C rectal temperature
Intervention: Device: Tecotherm-HELIX
Publications * Oliveira V, Kumutha JR, E N, Somanna J, Benkappa N, Bandya P, Chandrasekeran M, Swamy R, Mondkar J, Dewang K, Manerkar S, Sundaram M, Chinathambi K, Bharadwaj S, Bhat V, Madhava V, Nair M, Lally PJ, Montaldo P, Atreja G, Mendoza J, Bassett P, Ramji S, Shankaran S, Thayyil S. Hypothermia for encephalopathy in low-income and middle-income countries: feasibility of whole-body cooling using a low-cost servo-controlled device. BMJ Paediatr Open. 2018 Mar 23;2(1):e000245. doi: 10.1136/bmjpo-2017-000245. eCollection 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 20, 2015)
62
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
50
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Month   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01760629
Other Study ID Numbers  ICMJE 3332/002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thayyil, Sudhin
Study Sponsor  ICMJE Thayyil, Sudhin
Collaborators  ICMJE
  • Government Medical College, Kozhikode
  • Institute for Child Health, Madras Medical College, Egmore, Chennai
  • Wayne State University
  • Manipal Hospital, India
Investigators  ICMJE
Principal Investigator: Sudhin Thayyil, PhD Imperial College London
Principal Investigator: Seetha Shankaran, MD Wayne State University, Michigan
PRS Account Thayyil, Sudhin
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP