Key result
Therapeutic hypothermia prolongs neonatal QTc intervals by ~98 ms compared to normothermia.
Why the study?
Reversible QTc prolongation during therapeutic hypothermia for neonatal encephalopathy after asphyxia was reported anecdotally, but structured reference values were lacking to support medication development.
Does therapeutic hypothermia prolong the QTc interval in late preterm and term neonates with encephalopathy?
Systematic Review (n=33)
Does therapeutic hypothermia prolong the QTc interval in late preterm and term neonates with encephalopathy?
Therapeutic hypothermia significantly prolongs the QTc interval in neonates, which is reversible upon rewarming and should be accounted for as a non-maturational covariate in neonatal pharmacovigilance.
Answers are grounded in this paper and cite their sources.
Supports QTc monitoring during neonatal therapeutic hypothermia; leaves open arrhythmic risk and need for prospective confirmation.
BACKGROUND: There are anecdotal reports on reversible QTc prolongation during therapeutic hypothermia (TH) for moderate to severe neonatal encephalopathy after asphyxia. As the QTc interval is a relevant biomarker for pharmacovigilance during medication development, a structured search and review on published neonatal QTc values to generate reference values is warranted to facilate medication development in this specific population. METHODS: A structured search and literature assessment (PubMed, Embase, and Google Scholar) with 'Newborn/Infant, QT and hypothermia' was conducted (October 2021). Retrieved individual values were converted to QTc (Bazett) over postnatal age (day 1-7). RESULTS: We retrieved 94 QTc intervals (during TH (n = 50, until day 3) or subsequent normothermia (n = 44, day 4-7)) in 33 neonates from 6 publications. The median (range) of QTc intervals during TH was 508 (430-678), and 410 (317-540) ms afterwards (difference 98 ms, or +28 ms/°C decrease). Four additional cohorts (without individual QTc intervals) confirmed the pattern and magnitude of the effect of body temperature on the QTc interval. CONCLUSIONS: We highlighted a relevant non-maturational covariate (°C dependent TH) and generated reference values for the QTc interval in this specific neonatal subpopulation. This knowledge on QTc during TH should be considered and integrated in neonatal medication development.
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Allegaert et al. (2021) conducted a systematic review in moderate to severe neonatal encephalopathy after asphyxia (n=33). Therapeutic hypothermia vs. Subsequent normothermia was evaluated on QTc interval (difference 98 ms, p=<0.001). Therapeutic hypothermia significantly prolonged the median QTc interval in neonates to 508 ms compared to 410 ms during subsequent normothermia, a difference of 98 ms (p < 0.001).
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