Evaluating the combined use of non-invasive respiratory support alongside preventative anticonvulsant treatment in children presenting to hospital with cerebral malaria and convulsions

Not Applicable

Completed

• Conditions: Cerebral malaria; Infections and Infestations; Plasmodium falciparum malaria with cerebral complications

• Registration Number: ISRCTN76942974
• Lead Sponsor: Imperial College London

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-05
• Study Completion: 2024-06-30
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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

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
Current primary outcome measure as of 07/03/2024: <br><br>1. Cumulative time with clinically detected epileptogenic seizure activity (witnessed) over 36 hours.<br><br>_____<br><br>Previous primary outcome measure:<br><br>1. Cumulative time with epileptogenic seizure activity will be determined by continuous EEG monitoring over 36 hours.<br>2. The number of additional antiepileptic drugs required will be determined at day 28, 90 and 180 by phone or face-to face.<br>3. The frequency of disability-free survival will be determined at day 28, 90 and 180 by phone or face-to face.