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  • Letter to the Editor
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Corrections regarding lucinactant and clinical trials involving lucinactant

Journal of Perinatology volume 29, page 72 (2009)Cite this article

The purpose of this letter is to address incorrect statements contained in the article by Dr Halliday entitled ‘Surfactants: past, present, and future,’ published in a supplement of the May 2008 issue of the Journal of Perinatology.1 The statements concern lucinactant, a peptide-containing synthetic surfactant currently under review by the United States Food and Drug Administration (US FDA), and clinical trials involving lucinactant that were mentioned in the article.

Dr Halliday states in his article that lucinactant is a gel at both room and body temperature, and that it needs to be heated to 44 °C in a water bath. Lucinactant, like the surfactants that are currently available in the US, requires refrigeration for transport and storage prior to use. At refrigeration temperatures of 2–8 °C lucinactant is in a gel state, but becomes a free flowing liquid after warming to 20–25 and 37 °C. In clinical trials, a dry block heater, referred to as a warming cradle,2, 3 was used to warm the lucinactant. A water bath was not recommended, and if used during a clinical trial would have been considered a protocol violation. The dry block heater temperature was set at 44 °C and the lucinactant vials were placed in the dry block heater for 15 min, as summarized in the published reports of the lucinactant trials.2, 3 This procedure avoids imprecision around warming methods using body heat or exposure to room temperatures that may range from 20–25 °C and assures that each dose of surfactant is prepared in an identical way. When warmed for 15 min in a dry block heater set at 44 °C, lucinactant reaches a temperature that approximates body temperature. It is important to note that it is neither necessary nor recommended to heat lucinactant so that it reaches a temperature of 44 °C.

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References

  1. Halliday HL . Surfactants: past, present, and future. J Perinatol 2008; 28: S47–S56.

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  2. Moya FR, Gadzinowski J, Bancalari E, Salinas V, Kopelman B, Bancalari A et al. A multicenter, randomized, masked, comparison trial of lucinactant, colfosceril palmitate, and beractant for the prevention of respiratory distress syndrome among very preterm infants. Pediatrics 2005; 115: 1018–1029.

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

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  4. Engle W, American Academy of Pediatrics Committee on Fetus and Newborn. Surfactant-replacement therapy for respiratory distress in the preterm and term neonate. Pediatrics 2008; 121: 419–432.

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  1. Discovery Laboratories, Warrington, PA, USA

    R G Clayton

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  1. R G Clayton
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Correspondence to R G Clayton.

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Clayton, R. Corrections regarding lucinactant and clinical trials involving lucinactant. J Perinatol 29, 72 (2009). https://doi.org/10.1038/jp.2008.127

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