Effects of domperidone on QTc interval in infants
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 enroled 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.
Document Type: Research Article
Affiliations: 1: Pediatric Gastroenterology, Hospital Pequeno Príncipe – Pontifical University of Paraná (PUCPR), Curitiba, Brazil 2: Cardiology, Hospital Pequeno Príncipe – Pontifical University of Paraná (PUCPR), Curitiba, Brazil 3: Bioinformatics and Modeling, ULg, Systems and Modeling Unit, Montefiore Institute, Liege, Belgium 4: Pediatrics, Ospedale “F. Del Ponte”, Università dell’Insubria, Varese, Italy 5: Department of Pediatrics, UZ BRUSSEL, Brussels, Belgium
Publication date: 2012-05-01