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The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls

Author

Listed:
  • Jill Vanthienen

    (KU Leuven)

  • Marine Vassilev Petrov

    (KU Leuven)

  • Thuy Mai Luu

    (University of Montreal
    University of Montreal)

  • Anik Cloutier

    (University of Montreal)

  • Anke Raaijmakers

    (KU Leuven
    ZNA Hospitals Antwerp)

  • Jan A. Staessen

    (Non-Profit Research Institute Alliance for the Promotion of Preventive Medicine
    KU Leuven)

  • Zhenyu Zhang

    (KU Leuven)

  • Thomas Salaets

    (University Hospitals Leuven)

  • Annouschka Laenen

    (KU Leuven)

  • Anne Smits

    (KU Leuven
    University Hospitals Leuven)

  • Anne-Monique Nuyt

    (University of Montreal
    University of Montreal)

  • Adrien Flahault

    (University of Montreal)

  • Karel Allegaert

    (KU Leuven
    KU Leuven
    Erasmus MC)

Abstract

Introduction Although relevant for precision pharmacovigilance, there are conflicting data on whether former preterm birth is associated with QTc-Bazett prolongation in later life. Methods To explore QTc-Bazett interval differences between former preterm and/or extremely low birth weight (ELBW) cases and term-born controls in adolescence and young adulthood, we analyzed pooled individual data after a structured search on published cohorts. To test the absence of a QTc-Bazett difference, a non-inferiority approach was applied (one-sided, upper limit of the 95% confidence interval [CI] mean QTc-Bazett difference, 5 and 10 ms). We also investigated the impact of characteristics, either perinatal or at assessment, on QTc-Bazett in the full dataset (cases and controls). Data were reported as median and range. Results The pooled dataset contained 164 former preterm and/or ELBW (cases) and 140 controls born full-term from three studies. The median QTc-Bazett intervals were 409 (335–490) and 410 (318–480) ms in cases and controls. The mean QTc-Bazett difference was 1 ms, with an upper 95% CI of 6 ms (p > 0.05 and p 10 ms in cases. When prescribing QTc-prolonging drugs, pharmacovigilance practices in this subpopulation should be similar to the general public (NCT05243537).

Suggested Citation

  • Jill Vanthienen & Marine Vassilev Petrov & Thuy Mai Luu & Anik Cloutier & Anke Raaijmakers & Jan A. Staessen & Zhenyu Zhang & Thomas Salaets & Annouschka Laenen & Anne Smits & Anne-Monique Nuyt & Adri, 2023. "The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from Term-Born Controls," Drug Safety, Springer, vol. 46(9), pages 897-904, September.
    • Handle: RePEc:spr:drugsa:v:46:y:2023:i:9:d:10.1007_s40264-023-01335-y
    DOI: 10.1007/s40264-023-01335-y
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