Evaluating the combined use of NOn-invasive Ventilation alongside preventative anticonvulsant treatment In children presenting to hospital with CErebral_Malaria and convulsions: a phase I trial

Imperial College London0 sites30 target enrollmentFebruary 5, 2019

Overview

2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/39184127/ (added 27/08/2024)

Registry

who.int

Start Date

February 5, 2019

End Date

June 30, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

•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)

•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