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Effects of cisapride on QTc interval in neonates
S Bernardini1, D S Semama, F Huet
1Centre Hospitalier Universitaire, Dijon, France.
Insights
Cisapride significantly prolonged the QTc interval in neonates, particularly those with lower birthweight or gestational age. This effect was asymptomatic but more common in premature infants, suggesting accumulation in immature neonates.
Area of Science:
- Neonatal pharmacology
- Pediatric cardiology
Background:
- Cisapride is a gastroprokinetic agent used in neonates.
- The QTc interval is a measure of cardiac repolarization, and prolonged intervals can increase the risk of arrhythmias.
Observation:
- A prospective survey was conducted on 49 neonates treated with cisapride.
- QTc intervals were measured before and after treatment initiation.
Findings:
- Cisapride significantly increased the QTc interval in neonates (p = 0.0001).
- The QTc interval prolongation was more pronounced in neonates with lower birthweight or gestational age.
- Clinically asymptomatic QTc prolongation above 0.450 occurred in 7 neonates, predominantly in those with gestational age ≤ 33 weeks (6 infants).
Implications:
- Cisapride appears to accumulate in less mature neonates.
- Further pharmacokinetic studies are warranted to understand cisapride disposition in this population.
- Clinical monitoring of QTc interval is recommended for neonates receiving cisapride, especially premature infants.
Aim:
Prospective survey of the effects of cisapride on QTc interval in neonates given cisapride.
Methods:
QTc interval was determined just before and 2.9 (0.9) days after outset of the treatment in 49 neonates treated with cisapride between 1 August 1995 and 29 February 1996.
Results:
Cisapride significantly increased QTc interval (p = 0.0001), and this was higher when birthweight or gestational age were lower. The prolongation of QTc interval above the arbitrary value of 0.450 (n = 7) was clinically asymptomatic and was significantly more common in the infants born with a gestational age < or = 33 weeks (n = 6).
Conclusion:
The findings indicate that cisapride accumulates in less mature neonates. Further pharmacokinetic studies are needed.