PEDIATRICS Vol. 90 No. 5 November 1992, pp. 781-782
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European Surfactant Trial: Questions About the Protocol

GUNTRAM DEICHSEL PHD1, KARL THOMAE GMBH 1, and FRAU DR VON SEEFELD 1

1 Medizinische Dienste, Postfach 17 55, D-7950 Biberach, Germany

To the Editor.—

The paper by Speer et al in the January 1992 issue of Pediatrics1 gives an impressive insight into current European surfactant research. What I missed, however, is a remark on the loopholes which inevitably occur during the conduct of a trial with intensive care patients.

A note on protocol violations certainly would explain the following discrepancy: 65% of the patients in the multiple-dose group required more than one dose, where an additional dose is to be given if there is need for supplementary oxygen (FIO2 > 0.21) after 12 or 24 hours (cf, middle of right column on pages 14 and 15).