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Optical coherence tomography in cerebral malaria

Predicting acute and post-recovery outcomes in cerebral malaria and other comas by optical coherence tomography

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN11735871
Enrollment
270
Registered
2022-12-09
Start date
2022-11-10
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prediction of acute and post-recovery outcomes in paediatric cerebral malaria Infections and Infestations

Interventions

This is a cohort study to determine if an imaging device can differentiate different groups within the cohort (severe brain swelling versus no/mild/moderate brain swelling
and in follow-up, neurodevelopmental deficit versus none). There is no randomisation or intervention. Some controls are being recruited in order to determine normal child development in this populatio

Sponsors

University of Liverpool
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Parent or guardian gives informed consent for their child’s participation 2. Cerebral malaria: under 16 years of age, BCS=2, Plasmodium falciparum parasitaemia on a blood film, no other cause of coma evident 3. Other comas: under 16 years of age, BCS=3 with acute presentation. 4. Healthy controls age-matched under 16 years

Exclusion criteria

Exclusion criteria: 1. Hypoglycaemia, post-ictal, or other transient state accounting for coma 2. Contraindication to MRI 3. History or evidence of pre-existing hydrocephalus, significant neurological disease, gross neurological disability or learning difficulties 4. History or evidence of pre-existing significant ocular disease 5. History or evidence of severe life-limiting or chronic disease including but not limited to advanced HIV/AIDS (Stage 4), disseminated TB and malignancy

Design outcomes

Primary

MeasureTime frame
Optic nerve head (ONH) swelling measured using optical coherence tomography (OCT) at admission, then daily during admission

Secondary

MeasureTime frame
1. Macular ischaemia measured using OCT at admission, then daily during admission 2. Acceptability of novel OCT measured using a 5-point scale at each use 3. Effectiveness of novel OCT measured using intraclass correlation coefficients during data analysis

Countries

Malawi

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026