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Archives of Disease in Childhood. Fetal and Neonatal Edition logoLink to Archives of Disease in Childhood. Fetal and Neonatal Edition
. 1995 Jan;72(1):F8–13. doi: 10.1136/fn.72.1.f8

Randomised clinical trial of two treatment regimens of natural surfactant preparations in neonatal respiratory distress syndrome.

C P Speer 1, O Gefeller 1, P Groneck 1, E Laufkötter 1, C Roll 1, L Hanssler 1, K Harms 1, E Herting 1, H Boenisch 1, J Windeler 1, et al.
PMCID: PMC2528411  PMID: 7743295

Abstract

AIMS--To compare treatment regimens of two widely used natural surfactant preparations Curosurf and Survanta in respiratory distress syndrome (RDS). METHODS--The effects of the two treatment regimens on gas exchange, ventilatory requirements, and 28 day outcome in infants with RDS were compared. Seventy five preterm infants (birth weight 700-1500 g) with RDS requiring artificial ventilation with an FIO2 of > or = 0.4, were randomly selected at 1-24 hours of age. One group received an initial dose of Curosurf (200 mg/kg); the other group Survanta (100 mg/kg). Patients who remained dependent on artificial ventilation with an FIO2 of > or = 0.3 received up to two additional doses of Curosurf (each of 100 mg/kg) after 12 and 24 hours or up to three additional doses of Survanta (each of 100 mg/kg) between six and 48 hours after the initial dose. RESULTS--There was a rapid improvement in oxygenation and ventilatory requirements were reduced in both groups. However, infants treated with Curosurf had a higher arterial:alveolar oxygen tension ratio and required a lower peak inspiratory pressure and mean airway pressure at several time points within 24 hours of randomisation (p < 0.05-0.001). The incidences of pneumothorax in the Curosurf and Survanta groups were 6% and 12.5%, respectively; the corresponding figures for grades 3-4 intracerebral haemorrhage were 3% and 12.5%, respectively. Mortality was 3% in the Curosurf group and 12.5% in the Survanta group. However, these differences did not reach significance. CONCLUSION--The Curosurf treatment regimen resulted in a more rapid improvement in oxygenation than Survanta and reduced ventilatory requirements up to 24 hours after start of treatment. This was associated with a trend towards reduced incidence of serious pulmonary and non-pulmonary complications.

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Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Egberts J., de Winter J. P., Sedin G., de Kleine M. J., Broberger U., van Bel F., Curstedt T., Robertson B. Comparison of prophylaxis and rescue treatment with Curosurf in neonates less than 30 weeks' gestation: a randomized trial. Pediatrics. 1993 Dec;92(6):768–774. [PubMed] [Google Scholar]
  2. Fawer C. L., Diebold P., Calame A. Periventricular leucomalacia and neurodevelopmental outcome in preterm infants. Arch Dis Child. 1987 Jan;62(1):30–36. doi: 10.1136/adc.62.1.30. [DOI] [PMC free article] [PubMed] [Google Scholar]
  3. Halliday H. L., Tarnow-Mordi W. O., Corcoran J. D., Patterson C. C. Multicentre randomised trial comparing high and low dose surfactant regimens for the treatment of respiratory distress syndrome (the Curosurf 4 trial). Arch Dis Child. 1993 Sep;69(3 Spec No):276–280. doi: 10.1136/adc.69.3_spec_no.276. [DOI] [PMC free article] [PubMed] [Google Scholar]
  4. Hellström-Westas L., Bell A. H., Skov L., Greisen G., Svenningsen N. W. Cerebroelectrical depression following surfactant treatment in preterm neonates. Pediatrics. 1992 Apr;89(4 Pt 1):643–647. [PubMed] [Google Scholar]
  5. Hoekstra R. E., Jackson J. C., Myers T. F., Frantz I. D., 3rd, Stern M. E., Powers W. F., Maurer M., Raye J. R., Carrier S. T., Gunkel J. H. Improved neonatal survival following multiple doses of bovine surfactant in very premature neonates at risk for respiratory distress syndrome. Pediatrics. 1991 Jul;88(1):10–18. [PubMed] [Google Scholar]
  6. Horbar J. D., Soll R. F., Sutherland J. M., Kotagal U., Philip A. G., Kessler D. L., Little G. A., Edwards W. H., Vidyasagar D., Raju T. N. A multicenter randomized, placebo-controlled trial of surfactant therapy for respiratory distress syndrome. N Engl J Med. 1989 Apr 13;320(15):959–965. doi: 10.1056/NEJM198904133201502. [DOI] [PubMed] [Google Scholar]
  7. Horbar J. D., Wright L. L., Soll R. F., Wright E. C., Fanaroff A. A., Korones S. B., Shankaran S., Oh W., Fletcher B. D., Bauer C. R. A multicenter randomized trial comparing two surfactants for the treatment of neonatal respiratory distress syndrome. National Institute of Child Health and Human Development Neonatal Research Network. J Pediatr. 1993 Nov;123(5):757–766. doi: 10.1016/s0022-3476(05)80856-x. [DOI] [PubMed] [Google Scholar]
  8. Jobe A. H. Pulmonary surfactant therapy. N Engl J Med. 1993 Mar 25;328(12):861–868. doi: 10.1056/NEJM199303253281208. [DOI] [PubMed] [Google Scholar]
  9. Liechty E. A., Donovan E., Purohit D., Gilhooly J., Feldman B., Noguchi A., Denson S. E., Sehgal S. S., Gross I., Stevens D. Reduction of neonatal mortality after multiple doses of bovine surfactant in low birth weight neonates with respiratory distress syndrome. Pediatrics. 1991 Jul;88(1):19–28. [PubMed] [Google Scholar]
  10. Newell D. J. Intention-to-treat analysis: implications for quantitative and qualitative research. Int J Epidemiol. 1992 Oct;21(5):837–841. doi: 10.1093/ije/21.5.837. [DOI] [PubMed] [Google Scholar]
  11. Nohara K., Berggren P., Curstedt T., Grossmann G., Nilsson R., Robertson B. Correlations between physical and physiological properties of various preparations of lung surfactant. Eur J Respir Dis. 1986 Nov;69(5):321–335. [PubMed] [Google Scholar]
  12. Papile L. A., Burstein J., Burstein R., Koffler H. Incidence and evolution of subependymal and intraventricular hemorrhage: a study of infants with birth weights less than 1,500 gm. J Pediatr. 1978 Apr;92(4):529–534. doi: 10.1016/s0022-3476(78)80282-0. [DOI] [PubMed] [Google Scholar]
  13. Skov L., Hellström-Westas L., Jacobsen T., Greisen G., Svenningsen N. W. Acute changes in cerebral oxygenation and cerebral blood volume in preterm infants during surfactant treatment. Neuropediatrics. 1992 Jun;23(3):126–130. doi: 10.1055/s-2008-1071327. [DOI] [PubMed] [Google Scholar]
  14. Soll R. F., Hoekstra R. E., Fangman J. J., Corbet A. J., Adams J. M., James L. S., Schulze K., Oh W., Roberts J. D., Jr, Dorst J. P. Multicenter trial of single-dose modified bovine surfactant extract (Survanta) for prevention of respiratory distress syndrome. Ross Collaborative Surfactant Prevention Study Group. Pediatrics. 1990 Jun;85(6):1092–1102. [PubMed] [Google Scholar]
  15. Speer C. P., Rethwilm M., Gahr M. Elastase-alpha 1-proteinase inhibitor: an early indicator of septicemia and bacterial meningitis in children. J Pediatr. 1987 Nov;111(5):667–671. doi: 10.1016/s0022-3476(87)80240-8. [DOI] [PubMed] [Google Scholar]
  16. Speer C. P., Robertson B., Curstedt T., Halliday H. L., Compagnone D., Gefeller O., Harms K., Herting E., McClure G., Reid M. Randomized European multicenter trial of surfactant replacement therapy for severe neonatal respiratory distress syndrome: single versus multiple doses of Curosurf. Pediatrics. 1992 Jan;89(1):13–20. [PubMed] [Google Scholar]
  17. Speer C. P., Ruess D., Harms K., Herting E., Gefeller O. Neutrophil elastase and acute pulmonary damage in neonates with severe respiratory distress syndrome. Pediatrics. 1993 Apr;91(4):794–799. [PubMed] [Google Scholar]

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