Elsevier

The Journal of Pediatrics

Volume 153, Issue 5, November 2008, Pages 663-666
The Journal of Pediatrics

Original article
Effect of Domperidone on QT Interval in Neonates

https://doi.org/10.1016/j.jpeds.2008.05.013Get rights and content

Objectives

To determine whether oral domperidone is associated with QT interval prolongation and ventricular arrhythmia and to identify factors that can influence these effects.

Study design

An electrocardiogram was performed before and after oral administration of domperidone in 31 neonates or infants classified into 3 groups according to gestational age.

Results

Oral domperidone is associated with QTc prolongation except in infants with a gestational age less than 32 weeks of amenorrhea (P < .005). Mean QTc prolongation was 14 msec. On univariate analysis, oral domperidone-induced QTc prolongation was correlated with gestational age, birth weight, and elevated serum potassium. On multivariate analysis, after adjustment for gestational age, serum potassium was the only factor independently associated with interval QT prolongation during treatment. No ventricular arrhythmias were observed.

Conclusions

This study shows a significant association between oral domperidone therapy and QTc prolongation. Two risk factors were identified: advanced gestational age and serum potassium at the upper limit of normal. It is recommended that measurement of the QT interval be done before and after oral domperidone therapy.

Section snippets

Methods

This study was conducted in neonates and infants, regardless of their gestational age (GA), admitted to a neonatology unit of Amiens University Hospital (France) between May 2005 and May 2006.

All infants requiring oral domperidone regardless of the indication were included. To comply with precautions similar to those recommended by the French Agency for the Safety of Health Products for cisapride, a prolonged ECG was performed in these infants before and after starting treatment. Routine

Results

The indication for domperidone therapy was gastroesophageal reflux in every case (Table). Domperidone was administered orally (1 mg/mL oral suspension) in 3 or 4 divided doses, 15 to 20 minutes before feeds. The mean daily dosage was 1.3 ± 0.7 mg/kg/day. Two infants accidentally received doses higher than the therapeutic range (>2.4 mg/kg/day), but neither of them developed QTc prolongation.

The first ECG was systematically performed before starting domperidone therapy, usually several hours

Discussion

This study reports QTc prolongation induced by oral domperidone; there have been a few isolated cases.9 The ΔQTc observed in this study was higher than the physiologic prolongation reported in the literature that is observed up until the 4th month of life and then declines. Schwartz et al reported a ΔQTc of 12 msec between the 4th day of life and the end of the 2nd month and Alimurung et al10 reported a value of 24 msec between the end of the 1st months and the end of the 4th month.

Several

References (22)

  • C. Rocha et al.

    QT interval prolongation associated with the oral use of Dompéridone in an infant

    Pediatr Cardiol

    (2005)
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    The authors declare no conflict of interest.

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