Doxapram Versus Placebo in Preterm Newborns: An International Double Blinded Multicenter Randomized Controlled Trial

What this Trial Is About

Preterm infants often experience apnea of prematurity (AOP), a condition where breathing temporarily stops due to immature respiratory systems. This can cause low oxygen levels and heart rate, potentially harming brain development. Researchers are studying whether doxapram, a respiratory stimulant given alongside standard treatments like caffeine and non-invasive ventilation, can reduce the need for invasive mechanical ventilation and protect brain and lung health in these infants. This is a phase 3, double-blind, randomized placebo-controlled trial conducted in neonatal intensive care units in the Netherlands and Belgium with an 8-year follow-up period. Participants will be randomly assigned to receive either doxapram or a placebo (5% glucose), both given as a loading dose followed by continuous infusion, initially by intravenous route and possibly by gastro-enteral route if appropriate. Therapy will be adjusted or stopped based on the infant's respiratory condition. If invasive mechanical ventilation is needed, the study drug is discontinued but may be restarted after extubation. The study aims to compare the safety and effectiveness of doxapram versus placebo in preventing death and severe disability at 2 years corrected age. During the study, infants will be closely monitored with routine clinical care assessments including respiratory status, blood tests, and neurological evaluations. Blood samples will be collected opportunistically to study doxapram levels. Follow-up visits will occur at 2, 5.5, and 8 years to assess long-term neurodevelopment and quality of life for both infants and their parents. Researchers will review outcomes such as death, lung disease, need for ventilation, neurological development, and complications related to prematurity.

Doxapram Therapy in Preterm Infants (DOXA Trial)