Some of the views expressed in the following notes on newly approved products should be regarded as preliminary, as there may have been limited published data at the time of publication, and little experience in Australia of their safety or efficacy. However, the Editorial Executive Committee believes that comments made in good faith at an early stage may still be of value. Before new drugs are prescribed, the Committee believes it is important that more detailed information is obtained from the manufacturer's approved product information, a drug information centre or some other appropriate source.
vials containing 120 mg/1.5 mL and 240 mg/3 mL
Approved indication: neonatal respiratory distress syndrome
Australian Medicines Handbook section 19.6.2
Surfactant lowers the surface tension of the alveolar membrane. Premature infants lack surfactant so their alveoli can collapse leading to respiratory distress. The respiratory distress syndrome can be managed or prevented by administering a substitute surfactant down an endotracheal tube. The first artificial surfactant was colfosceril palmitate, but this is no longer marketed in Australia. Beractant is still available. It is a surfactant derived from cows' lungs, whereas poractant alfa is derived from pigs' lungs.
Most of the early trials of poractant alfa were in Europe where it has been approved for marketing for more than 10 years. In a study of 146 babies with respiratory distress syndrome the 28-day mortality rate was 31% in the group who received poractant compared with 51% in the group who did not.1 Two years later there were no differences between the groups in growth, disability and respiratory symptoms.2
If the baby does not respond to the first dose, a half dose may be given after 12 and after 24 hours. Babies given repeat doses have a lower mortality rate at 28 days than those given a single dose (13% versus 21%).3
Subsequent studies have investigated if giving poractant to babies at risk of respiratory distress is more effective than waiting for the syndrome to appear. A meta-analysis of these studies showed that the neonatal mortality rate was 15% when poractant was used for prophylaxis and 25% when it was used for treatment. However, prophylaxis did not have a significant advantage in the prevention of chronic lung disease of the newborn.4
Administering poractant is not without risk. The endotracheal tube can get blocked and the baby may develop oxygen desaturation, hypotension and bradycardia.
- Collaborative European Multi center Study Group. Surfactant replacement therapy for severe neonatal respiratory distress syndrome. Pediatrics 1988;82:683-91.
- Robertson B, Curstedt T, Tubman R, Strayer D, Berggren P, Kok J, et al. A 2-year follow up of babies enrolled in a European multi centre trial of porcine surfactant replacement for severe neonatal respiratory distress syndrome. Eur J Pediatr 1992;151:372-6
- Speer CP, Robertson B, Curstedt T, Halliday HL, Compagnone D, Gefeller O, et al. Randomized European multi center trial of surfactant replacement therapy for severe neonatal respiratory distress syndrome: single versus multiple doses of Curosurf. Pediatrics 1992;89:13-20.
- Egberts J, Brand R, Walti H, Bevilacqua G, Breart G, Gardini F. Mortality, severe respiratory distress syndrome, and chronic lung disease of the newborn are reduced more after prophylactic than after therapeutic administration of the surfactant Curosurf. Pediatrics 1997;100:e4.
- Speer CP, Gefeller O, Groneck P, Laufkotter E, Roll C, Hanssler L, et al. Randomised clinical trial of two treatment regimens of natural surfactant preparations in neonatal respiratory distress syndrome. Arch Dis Child 1995;72:F8-13.
- Ramanathan R, Rasmussen MR, Gerstmann DR, Finer N, Sekar K, et al. A randomized, multi center masked comparison trial of poractant alfa (Curosurf) versus beractant (Survanta) in the treatment of respiratory distress syndrome in preterm infants. Am J Perinatol 2004;21:109-19.