Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol
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    Sample size amendment
    • Rebecca Cannings-John, Principal Research Fellow in Statistics Centre for Trials Research, Cardiff University

    I am writing to you regarding an amendment to the sample size section of the following 2021 published protocol paper: Mylrea-Foley B et al. TRUFFLE 2 Collaborators List. Perinatal and 2-year neurodevelopmental outcome in late preterm fetal compromise: the TRUFFLE 2 randomised trial protocol. BMJ Open. 2022 Apr 15;12(4):e055543. doi: 10.1136/bmjopen-2021-055543. PMID: 35428631; PMCID: PMC9014041.

    In light of a higher-than-expected overall rate of the primary outcome and based on advice from both the TRUFFLE 2 Independent Data Monitoring and the Trial Steering Committees, we have had to amend our sample size for the TRUFFLE 2 randomised trial. It is important for transparency, that the new section is published, and can be found below.

    Yours sincerely,

    Dr Rebecca Cannings-John, on behalf of the TRUFFLE 2 Trial Management Group

    Statistics and data analysis

    Sample size

    The trial is powered to detect if immediate delivery following cerebral redistribution is superior to expectant management following cerebral redistribution on this outcome. The original sample size was based on a difference in the proportion with the primary outcome from 15% in the delayed delivery to 9% in the immediate delivery (based on the TRUFFLE 2 feasibility study) and demonstrated an odds ratio (OR) of 0.56. At two-sided 5% significance with 95% power, 780 participants per arm were required, giving 1560 in total.

    In light of a higher than expected overa...

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    Conflict of Interest:
    I am the trial statistician for the TRUFFLE 2 RCT