Key result
Oral domperidone does not prolong infant QTc overall, but ~4% develop clinically significant prolongation.
Why the study?
Does oral domperidone prolong the QTc interval in infants with gastro-oesophageal reflux disease?
Observational (n=45)
Does oral domperidone prolong the QTc interval in infants with gastro-oesophageal reflux disease?
While oral domperidone did not significantly prolong the QTc interval at the group level in infants, clinically significant prolongation occurred in 4.4% of cases, suggesting routine ECG monitoring may be warranted.
4.4% significant QTc prolongation rate warrants caution in infants; leaves open arrhythmia risk assessment in prospective cohorts.
AIM: To prospectively evaluate the effects of oral domperidone on the QTc interval in infants. METHODS: Infants (0-1 year) with a diagnosis of gastro-oesophageal reflux (GOR) disease were included. A 12-lead electrocardiography (ECG) was performed in all infants at baseline and 1 h after the intake of domperidone after 7-14 days; the corrected QTc interval was calculated by one investigator (MV) according to Bazett's formula. RESULTS: Forty-five infants were enrolled in this study. The mean gestational age was of 38.6 weeks (35.5-42.0), and the mean age at the start of domperidone was 75.3 days (19-218 days). No statistically significant difference in corrected QTc was observed between baseline and the second ECG (0.389 ± 0.02 vs. 0.397 ± 0.31; p 0.130)). A trend was observed regarding gender: Although there was no difference in QTc change in girls (p 0.622), there was a strong trend in boys (p 0.051). Two infants (both boys) had a clinically significant QTc prolongation (> 460 msec) without symptoms. The Spearman correlation test showed no relation between the QTc change and age (r: -0.05822; p 0.7284). There was no relation between domperidone dosage and QTc change. CONCLUSION: Overall, the group-analysis showed no statistical significant difference in QTc duration induced by domperidone. However, 2/45 (4.4%) infants had a prolonged QTc interval (> 460 msec) induced by domperidone. As a consequence, QTc measurement should be recommended in routine in infants when domperidone is started.
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Vieira et al. (2012) conducted an observational in gastro-oesophageal reflux (GOR) disease (n=45). oral domperidone vs. baseline was evaluated on corrected QTc interval (p=0.130). Oral domperidone did not significantly prolong the corrected QTc interval in infants compared to baseline (0.397 vs 0.389 seconds; p=0.130), though 4.4% developed clinically significant prolongation.
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