Preterm infants often suffer from apnea of prematurity (AOP; a cessation of breathing) due to
immaturity of the respiratory system. AOP can lead to oxygen shortage and a low heart rate
which might harm the development of the newborn, especially the central nervous system. In
order to prevent oxygen shortage, infants are treated with non-invasive respiratory support
and caffeine. Despite these treatments, many preterm newborns still suffer from AOP and need
invasive mechanical ventilation. Although this will result in complete resolution of AOP,
invasive mechanical ventilation has the disadvantage of being a major risk of chronic lung
disease and impaired neurodevelopmental outcome. Restrictive invasive ventilation is
therefore advocated nowadays in preterm infants. Doxapram is a respiratory stimulant that has
been administered off-label to treat AOP. Doxapram, as add-on treatment, seems to be
effective in treating AOP and to prevent invasive mechanical ventilation. It is unclear if a
preterm infant benefit from doxapram treatment on the longer term. This study compares
doxapram to placebo and hypothesizes that doxapram will protect preterm infants from both
invasive ventilation (and related lung disease) and AOP related oxygen shortage (and related
impaired brain development).
Phase:
Phase 3
Details
Lead Sponsor:
Erasmus Medical Center
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Nederlands Neonataal Netwerk (N3), the Netherlands Universitaire Ziekenhuizen Leuven