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

S. Ainsworth, M. Beresford, D. Milligan, N J Shaw, J. Matthews, A. Fenton, M. Ward Platt

Research output: Contribution to journalArticle

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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% Cl 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.
Original languageEnglish
Pages (from-to)1387-1392
JournalThe Lancet
Volume355
Issue number9213
DOIs
Publication statusPublished - 2000

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Surface-Active Agents
Pregnancy
Mortality
Clinical Trials Data Monitoring Committees
Therapeutics
Intention to Treat Analysis
Constitution and Bylaws
Randomized Controlled Trials
Odds Ratio
Steroids
poractant alfa
Safety

Cite this

Ainsworth, S., Beresford, M., Milligan, D., Shaw, N. J., Matthews, J., Fenton, A., & Ward Platt, M. (2000). Pumactant and poractant alfa for treatment of respiratory distress syndrome in neonates born at 25—29 weeks' gestation: a randomised trial. The Lancet, 355(9213), 1387-1392. https://doi.org/10.1016/S0140-6736(00)02136-X
Ainsworth, S. ; Beresford, M. ; Milligan, D. ; Shaw, N J ; Matthews, J. ; Fenton, A. ; Ward Platt, M. / Pumactant and poractant alfa for treatment of respiratory distress syndrome in neonates born at 25—29 weeks' gestation: a randomised trial. In: The Lancet. 2000 ; Vol. 355, No. 9213. pp. 1387-1392.
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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{\%} Cl 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.",
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Ainsworth, S, Beresford, M, Milligan, D, Shaw, NJ, Matthews, J, Fenton, A & Ward Platt, M 2000, 'Pumactant and poractant alfa for treatment of respiratory distress syndrome in neonates born at 25—29 weeks' gestation: a randomised trial', The Lancet, vol. 355, no. 9213, pp. 1387-1392. https://doi.org/10.1016/S0140-6736(00)02136-X

Pumactant and poractant alfa for treatment of respiratory distress syndrome in neonates born at 25—29 weeks' gestation: a randomised trial. / Ainsworth, S.; Beresford, M.; Milligan, D.; Shaw, N J; Matthews, J.; Fenton, A.; Ward Platt, M.

In: The Lancet, Vol. 355, No. 9213, 2000, p. 1387-1392.

Research output: Contribution to journalArticle

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T1 - Pumactant and poractant alfa for treatment of respiratory distress syndrome in neonates born at 25—29 weeks' gestation: a randomised trial

AU - Ainsworth, S.

AU - Beresford, M.

AU - Milligan, D.

AU - Shaw, N J

AU - Matthews, J.

AU - Fenton, A.

AU - Ward Platt, M.

PY - 2000

Y1 - 2000

N2 - 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% Cl 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.

AB - 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% Cl 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.

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DO - 10.1016/S0140-6736(00)02136-X

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VL - 355

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JO - The Lancet

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