PEDIATRICS Vol. 90 No. 5 November 1992, pp. 782
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European Surfactant Trial: Questions About the Protocol

CHRISTIAN P. SPEER MD1 and OLAF GEFELLER PHD2

1 Department of Pediatrics, University of Göttingen, Robert-Koch-Straße 40, D-3400 Göttingen, Germany
2 Department of Medical Statistics, University of Göttingen, Humboldtallee 32, D-3400 Göttingen, Germany

In Reply.—

We appreciate Dr Deichsel's interest in the Randomized European Multicenter Trial of Surfactant Replacement Therapy1 and welcome the opportunity to clarify the points raised in his letter. Although we agree with Dr Deichsel that protocol violations are a pervasive problem in any clinical trial, we feel puzzled by his line of reasoning. Why does he argue that "a remark on the loopholes which inevitably occur during the conduct of a trial with intensive care patients" is missing? The correct observations that 35% of the patients in the multiple-dose group required only one surfactant dose and the 25th percentile of the distribution o the total time of exposure to oxygen in the same group is as high as 26 hours leads him to the strange conclusion that only protocol violations in our trial could explain this discrepancy.