Abstract
Clinical data from a total of 164 babies with severe respiratory distress syndrome treated with a single dose of porcine surfactant (Curosurf, 200 mg/kg body weight) were subjected to multiple regression analysis in order to identify factors influencing the response to replacement therapy. At entry all babies were being treated with artificial ventilation, requiring at least 60% oxygen; the first 77 babies were part of a controlled trial, and an additional 87 babies were treated without controls once the benefit of surfactant therapy had been established. Both series of patients showed a sustained doubling of the mean arterial/alveolar oxygen tension ratio (a/APO2) after treatment with surfactant. Mortality was only 15% in the new series of treated patients, and the number of survivors without evidence of chronic lung disease after 28 days remained twice as high as that of the control group in the randomized study (55% vs. 26%;P<0.001). High fraction of inspired oxygen requirement at entry had a negative impact on a/APO2 6h and 24h after treatment. The duration of artificial ventilation and total time in >21% oxygen were lower in heavier babies, who also had a lower mortality. Male and outborn babies had a higher mortality. Perinatal asphyxia (Apgar score <7 at 5 min) and high airway pressure requirement at entry were associated with increased mortality. Hospital allocation had a significant impact on all dependent variables. We also analysed the incidence of complications in relation to the therapeutic response pattern. Babies with a high arterial oxygen tension peak (>30kPa) within 30 min of surfactant replacement had a higher incidence of grade I–II intracranial haemorrhage than those with a lower peak. High a/APO2 24 h after treatment was associated with a lower incidence of both pneumothorax and grade III–IV cerebral haemorrhage, but a higher incidence of patent ductus arteriosus. We conclude that the response to surfactant replacement therapy is influenced by several factors including asphyxia, sex, and the severity of the disease, and that the incidence of important complications varies with the initial response pattern.
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Abbreviations
- a/APO2 :
-
arterial/alveolar oxygen tension ratio
- BPD:
-
bronchopulmonary dysplasia
- FiO2 :
-
fraction of inspired oxygen
- ICH:
-
intracranial haemorrhage
- PaO2 :
-
arterial oxygen tension
- PDA:
-
patent ductus arteriosus
- PIE:
-
pulmonary interstitial emphysema
- PTX:
-
pneumothorax
- RDS:
-
respiratory distress syndrome
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Director of the trial: B. Robertson, St. Göran's Children's Hospital, Stockholm.Preparation of surfactant: T. Curstedt, Danderyd's Hospital, Danderyd.Trial coordinator: G. Noack, St. Göran's Children's Hospital, Stockholm.Trial collaborators: J. Kok, J. Koppe, L. van Sonderen, Akademisch Ziekenhuis, Amsterdam; H. Halliday, G. McClure, B. McCord, M. Reid, Royal Maternity Hospital, Belfast; S. B. Oetomo, A. Okken, University Hospital, Groningen; K. Harms, E. Herting, C. P. Speer, Universitäts-Kinderklinik, Göttingen; B. Andreason, N. Svenningsen, Lasarettet, Lund; J.-P. Relier, H. Walti, Hôpital Port-Royal, Paris; G. Bevilacqua, E. V. Cosmi, L. Gaioni, S. Parmigiani, G. Rondini, E. Volante, Institutes of Neonatology, Parma, Pavia and Mantua; P. Berggren, P. Herin, G. Noack, St. Göran's Children's Hospital, Stockholm.Consultant statisticans: S. Ekblom, P. Karlsson, Statistical Research Group, Stockholm University.Consultant microbiologist: K.-E. Myrbäck, Department of Clinical Bacteriology, Södersjukhuset, Stockholm
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Collaborative European Multicentre Study Group. Factors influencing the clinical response to surfactant replacement therapy in babies with severe respiratory distress syndrome. Eur J Pediatr 150, 433–439 (1991). https://doi.org/10.1007/BF02093727
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DOI: https://doi.org/10.1007/BF02093727