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| Name | Class |
|---|---|
| Government Medical College, Kozhikode | OTHER |
| Institute for Child Health, Madras Medical College, Egmore, Chennai | UNKNOWN |
| Wayne State University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cooling arm | Experimental | Whole body cooling to 33 to 34 C rectal temperature |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecotherm-HELIX | Device | Whole body cooling using Tecotherm-HELIX |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudhin Thayyil, PhD | Imperial College London | Principal Investigator |
| Seetha Shankaran, MD | Wayne State University, Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Manipal Hospital | Bangalore | India | ||||
| Calicut Medical College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29637198 | Derived | 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. |
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| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D007036 | Hypothermia, Induced |
| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D013812 | Therapeutics |
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| Manipal Hospital, India |
| OTHER |
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| Calicut |
| India |
| Institute of Child Health, Madras Medical College | Chennai | India |
| D013568 | Pathological Conditions, Signs and Symptoms |