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 个研究点目标入组 30 人开始时间: 2019年2月5日最近更新: 2024年9月9日

适应症

试验速览

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

•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

•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

发起方