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The Lacuna Trial: a double-blind randomized controlled pilot trial of lactoferrin supplementation in the very preterm infant

Journal of Perinatology volume 36, pages 666–669 (2016)Cite this article

Subjects

Abstract

Objective:

To determine tolerability of bovine lactoferrin (bLF) in very preterm infants, and whether the intervention can be adequately masked.

Study Design:

In a single-center masked pilot trial infants under 31 weeks gestation were randomized before 48 h of age to receive milk with 100 mg per day of bLF or control. The primary outcome was feeding tolerance, defined as time to achieve full feeds (140 ml kg−1 per day). Parents answered a short questionnaire regarding acceptability of the intervention.

Results:

Seventy-nine infants were enrolled and analyzed according to intention to treat. There was no effect of bLF on the primary outcome. In addition, mortality, late onset sepsis and other complications of prematurity were no different. Equal numbers of parents in both groups believed their infant received bLF.

Conclusion:

We demonstrated that bLF is well tolerated, easy to administer and its presence in prepared milk is not evident. Trial registration number ISRCTN66482337.

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Acknowledgements

bLF was generously donated by AOR, Calgary, AB, Canada. They had no input in study design, they did not have access to the study data. The article was written by the authors alone. We acknowledge the excellent assistance of Julie Lavoie and Guylaine Aubé. Bovine lactoferrin was donated by AOR, Calgary, AB, Canada. There was no external funding.

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Authors and Affiliations

  1. Department of Pediatrics, University of Montréal Ste Justine Hospital, Centre Hospitalier Universitaire Sainte Justine, Montréal, QC, Canada

    K J Barrington, M-A Assaad & A Janvier

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  1. K J Barrington
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  2. M-A Assaad
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  3. A Janvier
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Correspondence to K J Barrington.

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The authors declare no conflict of interest.

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Barrington, K., Assaad, MA. & Janvier, A. The Lacuna Trial: a double-blind randomized controlled pilot trial of lactoferrin supplementation in the very preterm infant. J Perinatol 36, 666–669 (2016). https://doi.org/10.1038/jp.2016.24

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