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

• ClinicalTrials.gov Identifier: NCT01760629
• Recruitment Status: Completed
• First Posted: January 4, 2013
• Last Update Posted: February 24, 2015
• Sponsor: Thayyil, Sudhin
• 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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Neonatal Encephalopathy	Device: Tecotherm-HELIX	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 62 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Hypothermia for Encephalopathy in Low Income Countries-Feasibility
• Study Start Date: April 2013
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cooling arm; Whole body cooling to 33 to 34 C rectal temperature	Device: Tecotherm-HELIX; Whole body cooling using Tecotherm-HELIX; Other Names: Therapeutic hypothermia; Whole body cooling

Outcome Measures

Primary Outcome Measures :

1. Feasibility of cooling [ Time Frame: 72 hours ]
   To examine feasibility of whole body cooling within six hours of birth in infants with neonatal encephalopathy

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: up to 1 Month (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

India

Manipal Hospital

Bangalore, India

Calicut Medical College

Calicut, India

Institute of Child Health, Madras Medical College

Chennai, India

Sponsors and Collaborators

Thayyil, Sudhin

Government Medical College, Kozhikode

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

Wayne State University

Manipal Hospital, India

Investigators

• Principal Investigator: Sudhin Thayyil, PhD; Imperial College London
• Principal Investigator: Seetha Shankaran, MD; Wayne State University, Michigan

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Thayyil, Sudhin
• ClinicalTrials.gov Identifier: NCT01760629
• Other Study ID Numbers: 3332/002
• First Posted: January 4, 2013
• Last Update Posted: February 24, 2015
• Last Verified: February 2015

Keywords provided by Thayyil, Sudhin:

Encephalopathy, Newborn, Low and Middle-income countries, Hypothermia

Additional relevant MeSH terms:

Brain Diseases; Hypothermia; Central Nervous System Diseases; Nervous System Diseases; Body Temperature Changes