Effects of domperidone on QTc interval in infants.
OBJECTIVE
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.


CONCLUSIONS
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.
Pediatric Gastroenterology, Hospital Pequeno Príncipe - Pontifical University of Paraná (PUCPR), Curitiba, Brazil.
M C
MC
Vieira
N I
NI
Miyague
K
K
Van Steen
S
S
Salvatore
Y
Y
Vandenplas
D000932:Antiemetics / Q000494:pharmacology*; D004294:Domperidone / Q000494:pharmacology*; D004562:Electrocardiography / Q000187:drug effects*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D011446:Prospective Studies; D013997:Time Factors
D000932:Antiemetics; D004294:Domperidone