Evaluating the combined use of non-invasive respiratory support alongside preventative anticonvulsant treatment in children presenting to hospital with cerebral malaria and convulsions
Phase 1
Recruiting
- Conditions
- Malaria
- Registration Number
- PACTR202112749708968
- Lead Sponsor
- Imperial College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Cumulative time with epileptogenic seizure activity will be determined by continuous EEG monitoring over 36 hours.
- Secondary Outcome Measures
Name Time Method