Neonatal Encephalopathy
Conditions
Keywords
Encephalopathy, Newborn, Low and Middle-income countries, Hypothermia
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.
Interventions
DEVICETecotherm-HELIX
Whole body cooling using Tecotherm-HELIX
Sponsors
Government Medical College, Kozhikode
Institute for Child Health, Madras Medical College, Egmore, Chennai
Wayne State University
Manipal Hospital, India
Thayyil, Sudhin
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Hours to 1 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of cooling | 72 hours | To examine feasibility of whole body cooling within six hours of birth in infants with neonatal encephalopathy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short term morbidity | 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. |
Countries
India
Outcome results
None listed