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  • Application of a new type of double-lumen endotracheal tube in preterm infants with respiratory distress syndrome: study protocol for a non-inferiority randomised controlled trial (NISA)

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Paediatrics
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Application of a new type of double-lumen endotracheal tube in preterm infants with respiratory distress syndrome: study protocol for a non-inferiority randomised controlled trial (NISA)
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  • Published on: 24 February 2025
    Implications of including multiple births in the NISA trial
    • Lisa N Yelland, Principal Research Fellow (Biostatistics) South Australian Health and Medical Research Institute
    • Other Contributors:
      • Kristy P Robledo, Senior Research Fellow (Biostatistics)

    We read the protocol paper for the NISA trial (1) with interest. One issue that we believe warrants further consideration relates to the inclusion of infants from a multiple birth. As this trial is being conducted in preterm infants less than 32 weeks’ gestation and multiple births are not part of the exclusion criteria, it is likely that a relatively high percentage of eligible infants will be from a multiple birth and their sibling(s) may also be eligible. Multiples generally provide less information about the effect of an intervention than unrelated singletons, due to similarities in the outcomes of infants from the same birth. This has implications for both the trial design and analysis that may not have been fully considered here.

    In our recent systematic review (2), we found that few published trials of preterm infants adequately account for multiple births. We are committed to improving practice around this issue and commend the authors for their consideration of multiple births in both the randomisation (stating that “twins or multiple births will be randomly assigned to each group, which means they will be randomly assigned according to birth order”; p3) and data collection tools (where the number of fetuses is recorded; online supplementary material 2). We further encourage the authors to:
    1. Consider the sample size/power implications of including multiple births in the trial. Our freely available online calculator may be useful for this purpose (3...

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    Conflict of Interest:
    In posting this rapid response, we are drawing readers’ attention to some of our published work.