Clinical trial NCT01760629: Hypothermia for Encephalopathy in Low Income Countries-Feasibilty
Official title: Hypothermia for Encephalopathy in Low Income Countries-Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Encephalopathy
Keywords: Encephalopathy, Newborn, Low and Middle-income countries, Hypothermia
Lead sponsor: Thayyil, Sudhin
Sponsor class: INDIV
Collaborators: name: Government Medical College, Kozhikode
name: Institute for Child Health, Madras Medical College, Egmore, Chennai
name: Wayne State University
name: Manipal Hospital, India
First posted: 2013-01-04
Enrollment: 62
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Feasibility of cooling
timeFrame: 72 hours
Secondary outcomes:
measure: Short term morbidity
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Manipal Hospital
city: Calicut
country: India
facility: Calicut Medical College
city: Chennai
country: India
facility: Institute of Child Health, Madras Medical College
Study officials:
affiliation: Imperial College London
name: Sudhin Thayyil, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University, Michigan
name: Seetha Shankaran, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.