Inhaled nitric oxide for the adjunctive therapy of severe malaria: Protocol for a randomized controlled trial
2011

Inhaled Nitric Oxide for Severe Malaria in Children

Sample size: 180 publication 10 minutes Evidence: moderate

Author Information

Author(s): Hawkes Michael, Opoka Robert O, Namasopo Sophie, Miller Christopher, Thorpe Kevin E, Lavery James V, Conroy Andrea L, Liles W Conrad, John Chandy C, Kain Kevin C

Primary Institution: Institute of Medical Sciences, University of Toronto, Canada

Hypothesis

Young children hospitalized with malaria will benefit from adjunctive inhaled nitric oxide (iNO), as determined by more rapid improvement in serum Ang-2 levels.

Conclusion

The study aims to determine if inhaled nitric oxide can improve outcomes in children with severe malaria.

Supporting Evidence

  • Severe malaria remains a major cause of global morbidity and mortality.
  • Adjunctive therapies that target the underlying pathophysiology of severe malaria may further reduce morbidity and mortality.
  • Low-flow inhaled nitric oxide is a US FDA-approved treatment for hypoxic respiratory failure in neonates.
  • Children in sub-Saharan Africa bear the greatest burden of malaria.
  • 10-30% of patients with severe malaria will die despite effective anti-malarial medications.

Takeaway

This study is testing if breathing in a special gas called nitric oxide can help kids with severe malaria get better faster.

Methodology

This is a randomized, placebo-controlled trial comparing inhaled nitric oxide to placebo in children aged 1-10 with severe malaria.

Potential Biases

Blinding challenges due to the gaseous nature of the treatment and monitoring for dose-dependent toxicities.

Limitations

The primary endpoint is a surrogate marker (Ang-2), which may be less compelling than mortality as an outcome.

Participant Demographics

Children aged 1-10 years with severe malaria.

Statistical Information

P-Value

p<0.05

Confidence Interval

95% CI 1800-3600 pg/mL/day

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1745-6215-12-176

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