Toggle Main Menu Toggle Search

Open Access padlockePrints

Pumactant and poractant alfa for treatment of respiratory distress syndrome in neonates born at 25-29 weeks' gestation: A randomised trial

Lookup NU author(s): Dr David Milligan, Professor John Matthews, Dr Alan Fenton, Dr Martin Ward Platt

Downloads

Full text for this publication is not currently held within this repository. Alternative links are provided below where available.


Abstract

Background: Exogenous surfactant preparations vary in their constitution and biophysical properties. Synthetic and animal-derived preparations lower the rate of death compared with controls. No significant differences in mortality or important long-term clinical outcomes have been shown between them in randomised trials. We did a randomised controlled trial to compare pumactant, a synthetic surfactant, with poractant alfa, an animal-derived surfactant, both of which are widely used in the UK. Methods: We enrolled 212 neonates born between 25 weeks' and 29 weeks and 6 days' gestation who were intubated for presumed surfactant deficiency and were free from life threatening malformations. We randomly assigned 105 neonates poractant alfa, and 107 pumactant. The primary outcome was duration of high-dependency care and mortality was a secondary outcome. Analysis was by intention to treat. Findings: Outcome data were analysed for 199 babies. The trial was stopped on the recommendation of the data and safety monitoring committee because mortality assumed a greater importance than the primary outcome. Predischarge mortality differed significantly between groups. in favour of poractant alfa (14.1 vs 31.0%, p = 0.006; odds ratio 0.37 [95% CI 0.18-0.76). This difference was sustained after adjustment for centre, gestation, birthweight, sex, plurality, and use of antenatal steroids. Interpretation: Mortality was unexpectedly lower among neonates who received poractant alfa than among those who received pumactant, and was independent of all the variables we investigated. Stopping the trial early may have widened the difference between the treatment groups.


Publication metadata

Author(s): Matthews JNS; Fenton AC; Ward Platt MP; Milligan DWA; Ainsworth SB; Beresford MW; Shaw NJ

Publication type: Article

Publication status: Published

Journal: Lancet

Year: 2000

Volume: 355

Issue: 9213

Pages: 1387-1392

ISSN (print): 0140-6736

ISSN (electronic): 1474-547X

Publisher: The Lancet Publishing Group

URL: http://dx.doi.org/10.1016/S0140-6736(00)02136-X

DOI: 10.1016/S0140-6736(00)02136-X

PubMed id: 10791521


Altmetrics

Altmetrics provided by Altmetric


Actions

Find at Newcastle University icon    Link to this publication


Share