Evaluation of the Efficacy and Safety of Inhaled Nitric Oxide as Adjunctive Treatment for Cerebral Malaria in Children
Malaria, Cerebral
About this trial
This is an interventional treatment trial for Malaria, Cerebral focused on measuring severe malaria, children, adjunctive treatment
Eligibility Criteria
Inclusion Criteria:
- Age between 2 months and 12 years.
- With malaria infection confirmed by a malaria antigen test and/or a positive blood smear examination
- AND sustained coma: achieving a Blantyre Coma Score less than 3 for 2, or more, hours after ruling out and treating hypoglycemia (blood glucose less than 2.2 mmol/l), ruling out meningitis, and ruling out and treating active clinical seizures.
Exclusion Criteria:
- Refusal to participate
- Other cause of coma (toxic or pre-existing severe neurological disease)
- Terminal respiratory failure (due to brainstem coning)
- Coagulopathic
- Clinically unstable enough to preclude venipuncture and phlebotomy
- Severe malnutrition defined by edema or a weight-for-height minus 3 SD;
- Evidence of pre-existing brain injury
- Advanced AIDS defined by WHO clinical staging 4;
Sites / Locations
- Mbarara Regional Referral Hospital
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
inhaled nitric oxide
Controls will receive small pulses of placebo study drug via the INOpulse delivery system. Oxygen saturation will be maintained above 94% by adding oxygen to inspired gas via a loose fitting mask when necessary.
Subjects randomized to the intervention arm will receive a dose equivalent to 80 ppm iNO in air using an INOpulse delivery system for 24 hours per day for a minimum of two days and until clinical improvement (coma recovery), death or a maximum of 5 days. Oxygen saturation will be maintained above 94% by adding oxygen to inspired gas via a loose fitting mask when necessary.