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Effects of cisapride on corrected QT interval, heart rate, and rhythm in infants undergoing polysomnography
A Benatar1, A Feenstra, T Decraene
1Department of Pediatric Cardiology, Academisch Ziekenhuis, Free University of Brussels, Brussels, Belgium.
Insights
Cisapride treatment in infants under 3 months prolonged the QTc interval, increasing cardiac risk. Judicious use of this prokinetic drug is recommended for this age group.
Area of Science:
- Pediatric Cardiology
- Neonatal Pharmacology
Background:
- Gastrointestinal prokinetic agents like cisapride are used in infants.
- Concerns exist regarding cisapride's potential cardiac effects, particularly QT interval prolongation.
Purpose of the Study:
- To investigate the impact of cisapride on electrocardiographic parameters in infants.
- To assess heart rate, rhythm, and QT interval in infants undergoing polysomnography.
Main Methods:
- A prospective study involving 252 infants, with 134 on cisapride and 118 controls.
- Infants were stratified into three age groups: <3 months, 3-6 months, and >6 months.
- Continuous ECG, saturation monitoring, and EEG were performed over 8 hours, with hourly QT interval and heart rate measurements.
Main Results:
- No significant difference in heart rate was observed between cisapride-treated infants and controls.
- Infants under 3 months treated with cisapride showed a statistically significant increase in QTc interval compared to controls.
- No arrhythmias or atrioventricular conduction abnormalities were detected in either group.
Conclusions:
- Cisapride use in infants under 3 months is associated with a prolonged QTc interval.
- The clinical implications of this QTc prolongation require further investigation and risk stratification.
- Caution and judicious prescribing of cisapride are advised for infants younger than 3 months.
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.