Cerebral Plasmodium falciparum malaria Infections and Infestations Plasmodium falciparum malaria
Conditions
Interventions
1. Enteral feeding upon admission through the NG tube
2. No feeding until able to take oral food or maximum until 60 hours after admission, followed by enteral feeding
Duration of treatment for both
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female patients with cerebral falciparum malaria defined as a Glasgow Coma Score (GCS) less than 11 or Blantyre Coma Scale (BCS) less than 3 (for pre-verbal children), and the presence of asexual forms of Plasmodium falciparum in the peripheral blood smear 2. The patient or attending relative able and willing to give informed consent 3. Greater than or equal to 2 years of age
Exclusion criteria
Exclusion criteria: 1. Patient or relatives unable or unwilling to give informed consent 2. Patients who already have the features of aspiration pneumonia 3. Contraindications to enteral feeding: 3.1. Circulatory shock 3.2. Mechanical bowel obstruction/ileus/ischaemic colitis 3.3. Severe diarrhoea, severe vomiting 3.4. Pancreatitis 4. Known allergies to artesunate or quinine 5. Pregnancy 6. Severely malnourished child (according to World Health Organization [WHO] criteria)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence of aspiration pneumonia 2. Incidence of hypoglycaemia (less than 2.2 mmol/L) 3. Coma recovery time. The coma recovery time is defined as the time until a Glasgow Coma Score of 15/15 (BCS 5/5 in preverbal kids). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of sepsis. Sepsis is defined as the presence of infection (other than malaria) in combination with systemic inflammatory response syndrome (SIRS) as indicated by greater than or equal to three of the following criteria: 1.1. Prolonged fever, i.e. axillary temperature greater than or equal to 38°C or core temperature of 36°C or lower 1.2. A heart rate of greater than or equal to 90 beats/min 1.3. A respiratory rate of greater than or equal to 20 breaths/min (up to 5 years greater than or equal to 40 breaths/min) or the use of mechanical ventilation for an acute respiratory process 1.4. A white-cell count of greater than or equal to 12 x 10^9/l or less than or equal to 4 x 10^9/l, or a differential count showing greater than 10% immature neutrophils 2. Time to sit independently, which will be assessed daily 3. Time to stand independently, which will be assessed daily 4. Time to eat independently, which will be assessed daily 5. Total duration (days) of admission in the hospital 6. Survival. In hospital mortality will be recorded. | — |
Countries
Bangladesh
Outcome results
None listed