Effect of cisapride on corrected QT interval in neonates.
OBJECTIVE
To evaluate the effect of cisapride on corrected QT (QTc) interval in neonates at the Queen Sirikit National Institute of Child Health.


METHODS
A prospective study was performed to see the effects of cisapride on QTc interval in 20 neonates between 1st July 2001 and 31st January 2002. QTc interval was determined just before, 48 hours, 7 days and 15 days after the start of treatment with cisapride. QTc interval was calculated by averaging QT/square root(RR) values obtained from 5 consecutive beats in lead II of the EKG. Baseline electrolyte and calcium levels were drawn on all infants before treatment of cisapride. Drug dose ranged from 0.1-0.2 mg/kg every 6 to 8 hours.


RESULTS
Twenty infants were enrolled in the survey but complete data was obtained on 18 infants only. QTc interval of > 0.45 seconds was not found in any neonate. There was no significant difference of QTc interval before and 48 hours, 7 days and 15 days after cisapride administration (p = 0.861). There were also no statistically significant effects of age at starting cisapride, weight, gestational age and dose on QTc interval (p = 0.581, 0.65, 0.8, and 0.497). There were no adverse effects such as diarrhea or jaundice during the study.


CONCLUSIONS
Term and preterm infants using cisapride at the doses of 0.4-0.8 mg/kg/day did not develop QTc prolongation, arrhythmias or adverse effects. In the absence of risk factors, cisapride may be safe for use in neonates.
Khorana
Meera
M
Neonatology Unit, Department of Pediatrics, Queen Sirikit National Institute of Child Health, Bangkok 10400, Thailand.
Chankajorn
Woranate
W
Kanjanapattanakul
Wiboon
W
Kirawittaya
Tawatchai
T
Horpaopan
Sunthorn
S
Chotigeat
Uraiwan
U
Sangtawesin
Waraporn
W
D000704:Analysis of Variance; D020117:Cisapride / Q000009:adverse effects / Q000627:therapeutic use*; D004562:Electrocardiography / Q000187:drug effects*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy*; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D007363:Intensive Care Units, Neonatal; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome
D005765:Gastrointestinal Agents; D020117:Cisapride