Doxapram to protect preterm newborns: an international double blinded multicenter randomized placebo controlled trial

Project summary

Preterm birth is the most common cause of neonatal death and related to important long term morbidity. Invasive mechanical ventilation is often needed after preterm birth because of underdeveloped lungs and breathing center, but is related to impaired outcome. Today, invasive mechanical ventilation is therefore minimized in preterm infants. The newborns’ own breathing is supported with non-invasive support with air and oxygen, and the breathing is stimulated with caffeine treatment. Unfortunately, apnea and oxygen desaturations often remain a problem in preterm infants. The desaturations and fluctuations in oxygen potentially affect the brain and its development.
Treatment with doxapram provides a promising solution in addition to standard of care for these infants. Doxapram is increasingly used off-label in our neonatal intensive care units. However, high quality research on efficacy and safety on the long term perspective of doxapram is missing, and urgently needed. This study by Simons and colleagues is a unique multicenter double blinded randomized placebo controlled trial, designed to determine if doxapram is able to protect newborns on the long term perspective.

The study aims to provide the highly needed knowledge about doxapram – if doxapram proves to be effective and safe, its use can be implemented into (inter)national guidelines.