ABSTRACT. Objective. To evaluate the effects of cisapride, a prokinetic gastrointestinal drug, on the electrocardiographic QT interval, heart rate, and rhythm in infants during routine 8-hour polysomnography. Reported electrocardiogram (ECG) and rhythm disturbances in a small number of patients with the use of cisapride provided the impetus for this prospective study.Study Design. Two hundred fifty-two infants born at term were enrolled. Of these, 134 were on cisapride therapy for suspected gastroesophageal reflux and 118 were not on cisapride and served as controls. Cisapride-treated and control infants were from the outset divided into 3 age groups; group 1: under 3 months of age; group 2: between 3 and 6 months of age; and group 3: >6 months of age. Continuous ECG bipolar limb lead I recording, saturation monitoring, and electroencephalography were conducted. QT intervals and heart rate were measured at hourly intervals.Results. Cisapride doses were: group 1 mean, 0.80 mg/kg/day (range: 0.38 -1.55); group 2 mean, 0.80 mg/kg/ day (range: 0.23-1.38); and group 3 mean, 0.72 mg/kg/day (range: 0.32-1.41). Heart rate was higher in the younger infants, with a gradual decrease with age. No difference in heart rate was detected between the cisapride and control groups. The QTc interval in patients in group 1 was statistically longer than the controls, when applying both Bazett's and Hodges' formulae for QT correction. The other age groups did not differ. No arrhythmia or atrioventricular conduction abnormalities were observed.Conclusion. Infants under 3 months of age on cisapride treatment had significantly longer QTc intervals (with Bazett's formula, the 98th percentile was 504 ms in the cisapride group vs 447 ms in controls). The clinical significance and risk of the increased QTc interval in these infants are unclear and need further evaluation and risk stratification. Meanwhile, cisapride should be judiciously prescribed in infants <3 months of age. Pediatrics 2000;106(6). URL: http://www.pediatrics.org/ cgi/content/full/106/6/e85; QT interval, QTc, cisapride, heart rate, heart rhythm, infants.ABBREVIATIONS. ECG, electrocardiogram; CYP, cytochrome P-450. C isapride, a prokinetic agent used in adults and children with gastrointestinal motility disorders, has been reported in some patients to increase the QT interval on the electrocardiogram (ECG). 1-3 Prolongation of the electrocardiographic QT interval may be either congenital 4 -6 or acquired. 7 Acquired prolongation of the QT interval can be caused by electrolyte disturbances (commonly hypokalemia and hypocalcemia), hypothermia, central nervous system injury, malnutrition, organophosphate poisoning, and medication. Medications that have been implicated include tricyclic antidepressants, macrolide antibiotics, phenothiazines, and antiarrhythmic agents. 7 The QT interval on the ECG represents the period from the beginning of depolarization (QRS complex) to the end of repolarization (T wave) of the ventricles. There are at least 5 different genes responsible for ...