CUROSURF (poractant alfa), pulmonary surfactant
NEONATOLOGY - Clarification
Opinions on drugs -
Posted on
Jan 20 2015
Reason for request
Re-assessment of the improvement in actual benefit
Substantial clinical added value in patients with respiratory distress syndrome due to pulmonary surfactant deficiency
- not breathing spontaneously at birth and requiring immediate intubation,
- breathing spontaneously at birth but not or no longer responding to continuous positive airway pressure (CPAP) and requiring intubation for stabilisation.
- CUROSURF has Marketing Authorisation in the treatment of premature infants presenting or at high risk of presenting respiratory distress syndrome (RDS) caused by pulmonary surfactant deficiency (hyaline membrane disease).
- In light of the available clinical data and recent advances in the management of RDS with antenatal corticosteroid therapy and less invasive routine methods, CUROSURF may be proposed for premature infants:
- breathing spontaneously at birth but no longer responding to CPAP and requiring intubation,
- not breathing spontaneously at birth and requiring intubation.
- The value of systematic prophylactic treatment with a surfactant is no longer apparent.
Clinical Benefit
Substantial |
- |
Insufficient |
Clinical Added Value
important |
- |