vanHensbroekGAM92‐4.
Methods | Randomised, method not specified; stratified by admission coma score and study centre, balanced over time in blocks of 10; allocation concealed in sealed envelopes; open; neurological sequelae assessors blinded Withdrawn before treatment: 3/579 (died) No exclusions or loss to follow‐up reported < 5% loss at 5 months follow‐up for persistent neurological sequelae |
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Participants | 576 Gambian children 1 to 9 years Cerebral malaria, Blantyre score 2 or less Asexual falciparum parasitaemia Excluded: disease other than malaria; recovered consciousness after correction of hypoglycaemia; QNN treatment before admission |
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Interventions | AMim vs QNNim:
1. AM 3.2 mg/kg on day 1, 1.6 mg/kg daily
2. QNN 20 mg/kg, then 10 mg/kg every 12 h Fansidar (25mg S, 1.25mg P) given after full recovery (in 2nd and 3rd year of the study); comatose patients given intravenous glucose/saline; hypoglycaemia managed with intravenous glucose; convulsions with diazepam, paraldehyde or phenobarbitone; transfusion if PCV < 15%; secondary infection treated with chloramphenicol |
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Outcomes | 1. Mortality at hospital 2. Persisting neurological sequelae (primary end‐points) 3. FCT 4. PCT (50, 90, 100%) 5. CRT 6. Neuorological sequelae at discharge, 1 & 5 months | |
Notes | Quality assessment: A, A, A Paluther Rhone‐Poulenc |