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Response to Russell Clayton

Journal of Perinatology volume 29, pages 73–74 (2009)Cite this article

Thank you for allowing me to respond to Dr Russell Clayton's letter which I enjoyed reading. Dr Clayton's concerns center on one surfactant product, namely lucinactant, which has been studied in two randomized clinical trials published in 2005.1, 2 His first concern relates to the need to warm lucinactant ‘at’ rather than ‘to’ 44 °C for 15 min and to my use of the term ‘water bath’ but Dr Clayton prefers ‘dry block heater’ or ‘warming cradle’. I derived my comments from the published papers that say: ‘At this temperature (4 °C), because of its unique peptide–phospholipid interaction, lucinactant is a gel that requires warming at 44 °C in a warming cradle for 15 min and subsequent shaking to be converted into liquid form’1 and ‘Before administration, lucinactant was placed in a specially designed warming cradle, set at 44 °C, for 15 min and was shaken vigorously to ensure a uniform, free-flowing, liquid instillate’.2 I apologize for inadvertently implying that lucinactant is heated ‘to’ rather than ‘at’ 44 °C and for using the term ‘water bath’ instead of ‘warming cradle’ and I am pleased to put the record straight on these.

Dr Clayton's second concern relates to the countries where the babies for these two trials were recruited.1, 2 I said that one study2 was ‘conducted mainly in South America’ and on examining the acknowledgments section it can be seen that six of the nine countries involved in this study were from South and Central America (Brazil, Chile, Ecuador, Uruguay, Mexico and Panama) whereas three were from Europe (Hungary, Poland and Russia). What neither the paper nor Dr Clayton tells us is the number of babies recruited by center or by country. I said that the other study1 was ‘conducted largely in Europe with many babies recruited in Poland’. Examination of the acknowledgments section of this paper shows that babies were recruited in eight countries: Canada, France, Hungary, Poland, Portugal, Spain, United Kingdom and United States; although the number of neonatal intensive care units per country is given neither the paper nor Dr Clayton provides numbers of participants enrolled by country or by center. I believe that the statements in my review are in line with the information available in the published papers.1, 2 However, Dr Clayton might like to provide the missing information on numbers recruited by center and by country so that others can make a judgment on this.

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References

  1. Sinha SK, Lacaze-Masmonteil T, Valls-I-Soler A, Wiswell TE, Gadzinowski J, Hajdu J et al. A multicenter, randomised, controlled trial of lucinactant versus poractant alfa among very premature infants at high risk for respiratory distress syndrome. Pediatrics 2005; 115: 1030–1038.

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  6. Discovery Laboratories, Inc. Discovery Laboratories announces results of its supportive phase 3 clinical trial of Surfaxin® for respiratory distress syndrome in premature infants. http://www.discoverylabs.com/2003pr/060403-PR.pdf(downloaded on 8 July 2008).

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  1. Perinatal Medicine, Royal Maternity Hospital, Belfast, UK

    H L Halliday

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Correspondence to H L Halliday.

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Halliday, H. Response to Russell Clayton. J Perinatol 29, 73–74 (2009). https://doi.org/10.1038/jp.2008.133

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