Cerebral malaria Infections and Infestations Plasmodium falciparum malaria with cerebral complications
Conditions
Interventions
Thirty children will be allocated in a phased evaluation to receive non-invasive respiratory support with biphasic cuirass ventilation (BCV
Hayek). This will be done sequentially. In the first phase BCV will be used alone (10 patients). In the second and third phases it will be used as a neuroprotective strategy in combination with proph
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 07/03/2024: 1. Aged 3 months to 12-years (up to 40 kg in weight for paediatric dosing of leviteracitam) 2. Hospitalised with: 2.1. Current or recent evidence of P. falciparum malaria (slide or rapid diagnostic test (RDT) positive) 2.2. Blantyre Coma Score 4 or less that persists even after correction for concurrent hypoglycaemia (defined as blood glucose <3 mmol/L) 2.3. History of seizures in this illness _____ Previous inclusion criteria: 1. Aged 3 months to 12-years 2. Hospitalised with: 2.1. Current or recent evidence of P. falciparum malaria (slide or rapid diagnostic test (RDT) positive) 2.2. Blantyre Coma Score 2 or less that persists even after correction for concurrent hypoglycaemia (defined as blood glucose <3 mmol/L) 2.3. History of seizures in this illness
Exclusion criteria
Exclusion criteria: 1. Known cerebral palsy or significant neuro-development delay (which will affect endpoint assessment) 2. Skin disease or burns preventing use of the BCV 3. Respiratory or cardio-respiratory arrest prior to enrolment 4. A comorbidity which clinician believes has a significant risk of poor outcome e.g. malignancy, end-stage renal failure, major cardiac condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 07/03/2024: 1. Cumulative time with clinically detected epileptogenic seizure activity (witnessed) over 36 hours. _____ Previous primary outcome measure: 1. Cumulative time with epileptogenic seizure activity will be determined by continuous EEG monitoring over 36 hours. 2. The number of additional antiepileptic drugs required will be determined at day 28, 90 and 180 by phone or face-to face. 3. The frequency of disability-free survival will be determined at day 28, 90 and 180 by phone or face-to face. | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility will be assessed by the ability to implement and operationalise the use of non-invasive respiratory support with BCV for the duration of a child’s coma. This will be measured by: 1. The ability of BCV to safely institute negative pressure ventilation, which will be determined by resolution of the clinical and monitoring (SpO2 and CO2) parameters for which BCV was implemented. 2. Assessing whether children are able to tolerate the use of BCV (judged by children remaining comfortable during transition from coma to a semiconscious state, as assessed by nurses and carers). 3. Whether we are able to clear any secretions by regular suctioning (if this is judged to be a problem). 4. Whether BCV interferes with monitoring the child and the time require by the nursing staff to implement and maintain its use. Safety endpoints: 1. Episodes of aspiration (determined by sudden decrease in oxygen saturations, and/or denovo presence of coarse chest crepitations, with evidence of gastric reflux/aspirate in the oropharynx). 2. Episodes of hypercarbia (defined as pCO2 level of greater than 45 mmHg). 3. Episodes of bradypnoea (defined as 36m respectively) and hypoxaemia (oxygen saturation <92%). 4. Development of hypotension (defined as systolic blood pressure <50 mm Hg in children younger than 12 months; <60 mm Hg in children 1-5 years and <70 mm Hg in children olderthan 5 years of age). 5. Use of additional anticonvulsants. 6. Neurological sequelae at day 180. 7. Day 28 and day 180 mortality. 8. Re-admission to hospital through day 180. 9. Serious adverse events and grade 3/4 adverse events through day 180. 10. Grade 3/4 adverse events through day 180. 11. Length of initial hospitalisation. | — |
Countries
Kenya
Contacts
Public ContactEmmanual Oguda
Outcome results
None listed