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

Hypothermia for Encephalopathy in Low Income Countries-Feasibility

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Encephalopathy
• Intervention / Treatment: Device: Tecotherm-HELIX

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Bangalore, India
    • Manipal Hospital
  • Calicut, India
    • Calicut Medical College
  • Chennai, India
    • Institute of Child Health, Madras Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 1 month (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of cooling	To examine feasibility of whole body cooling within six hours of birth in infants with neonatal encephalopathy	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Thayyil, Sudhin
• Collaborators: Wayne State University; Government Medical College, Kozhikode; Institute for Child Health, Madras Medical College, Egmore, Chennai; Manipal Hospital, India
• Investigators: Principal Investigator: Seetha Shankaran, MD, Wayne State University, Michigan

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (ACTUAL): December 1, 2014
• Study Completion (ACTUAL): December 1, 2014

Study Registration Dates

• First Submitted: January 2, 2013
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (ESTIMATE): January 4, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): February 24, 2015
• Last Update Submitted That Met QC Criteria: February 20, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Encephalopathy, Newborn, Low and Middle-income countries, Hypothermia
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Body Temperature Changes; Brain Diseases; Hypothermia
• Other Study ID Numbers: 3332/002