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Clinical Trials/PACTR202112749708968
PACTR202112749708968
Recruiting
Phase 1

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 enrollmentNovember 18, 2021
ConditionsMalaria

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Malaria
Sponsor
Imperial College London
Enrollment
30
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 18, 2021
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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