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Effects of domperidone on QTc interval in infants
M C Vieira1, N I Miyague, K Van Steen
1Pediatric Gastroenterology, Hospital Pequeno Príncipe - Pontifical University of Paraná (PUCPR), Curitiba, Brazil.
Insights
Oral domperidone did not significantly alter QTc interval in infants with gastro-oesophageal reflux. However, a small percentage experienced QTc prolongation, suggesting routine monitoring is advisable.
Area of Science:
- Pediatric Cardiology
- Clinical Pharmacology
Background:
- Gastro-oesophageal reflux (GOR) is common in infants.
- Domperidone is frequently prescribed for GOR.
- Potential QTc interval prolongation is a concern with domperidone.
Purpose of the Study:
- To prospectively evaluate the effects of oral domperidone on the QTc interval in infants.
- Assess domperidone's impact on cardiac repolarization in pediatric patients.
Main Methods:
- Prospective study of infants (0-1 year) with GOR.
- Electrocardiography (ECG) performed at baseline and 1 hour post-domperidone.
- Corrected QTc interval calculated using Bazett's formula.
Main Results:
- No statistically significant difference in QTc interval observed overall.
- A trend towards QTc prolongation was noted in male infants (p=0.051).
- Two infants (4.4%) showed clinically significant QTc prolongation (>460 msec).
Conclusions:
- Domperidone did not significantly prolong QTc interval in the overall infant group.
- Clinically significant QTc prolongation occurred in a small subset of infants.
- Routine QTc interval monitoring is recommended when initiating domperidone 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 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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