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The QTc-Bazett Interval in Former Very Preterm Infants in Adolescence and Young Adulthood is Not Different from
Jill Vanthienen1, Marine Vassilev Petrov1, Thuy Mai Luu2,3
1Department of Development and Regeneration, KU Leuven, Herestraat 49, 3000, Leuven, Belgium.
Insights
Former preterm birth does not significantly alter QTc-Bazett intervals in later life. Pharmacovigilance for QTc-prolonging drugs in this population can follow general guidelines.
Area of Science:
- Cardiology
- Neonatology
- Pharmacovigilance
Background:
- Conflicting data exist regarding QTc-Bazett prolongation in individuals with a history of preterm birth.
- Understanding these cardiac electrophysiology differences is crucial for precision pharmacovigilance.
Purpose of the Study:
- To investigate QTc-Bazett interval differences between former preterm/extremely low birth weight (ELBW) individuals and term-born controls in adolescence and young adulthood.
- To assess the potential for prolonged QTc-Bazett in this cohort and inform pharmacovigilance strategies.
Main Methods:
- Pooled analysis of individual data from published cohorts using a structured search.
- Applied a non-inferiority approach to test for absence of QTc-Bazett difference (upper 95% CI mean difference of 5 and 10 ms).
- Investigated impact of perinatal and assessment characteristics on QTc-Bazett.
Main Results:
- Pooled dataset included 164 former preterm/ELBW cases and 140 term-born controls.
- Mean QTc-Bazett difference was 1 ms (95% CI: 6 ms), not significantly different between groups.
- Females exhibited significantly longer QTc-Bazett intervals than males in the full dataset.
Conclusions:
- QTc-Bazett intervals are not significantly different in former preterm/ELBW individuals compared to term-born controls.
- A potential prolongation of QTc-Bazett > 10 ms in former preterm individuals was rejected.
- Pharmacovigilance for QTc-prolonging drugs in this population should align with general public practices.
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 < 0.01 for 5 and 10 ms, respectively). In the full dataset, females had a significantly longer QTc-Bazett than males (415 vs. 401 ms; p < 0.0001).
Conclusions:
QTc-Bazett intervals are not significantly different between former preterm and/or ELBW cases and term-born controls, and we rejected a potential prolongation > 10 ms in cases. When prescribing QTc-prolonging drugs, pharmacovigilance practices in this subpopulation should be similar to the general public (NCT05243537).
