OBJECTIVE: To assess the effect of cisapride on gastric emptying and gastro-oesophageal reflux (GOR) symptoms in preterm infants with feed intolerance. METHODS:Sixteen preterm infants (gestational age 24-35 weeks) with feed intolerance were enrolled in the study. Infants were randomized to receive 7 days of cisapride 0.2 mg/kg four times a day, immediately followed by 7 days of placebo or vice versa. Gastric emptying was measured using the [13C]-octanoic acid breath test prior to study entry and repeated on day 5, 6 or 7 after randomization and 5, 6 or 7 days after crossover. The symptoms of GOR were monitored during the study period using a standardized reflux chart. Weight was recorded daily. RESULTS: There was no change in gastric emptying in infants prescribed cisapride (gastric half-emptying time (t1/2) 31.9 +/- 4.7 vs 34.2 +/- 3.9 min for placebo vs cisapride, respectively; P = 0.65). Infants on cisapride had slower growth and there was no change in reflux symptoms. CONCLUSIONS: The use of cisapride in preterm infants with feed intolerance cannot be recommended.
RCT Entities:
OBJECTIVE: To assess the effect of cisapride on gastric emptying and gastro-oesophageal reflux (GOR) symptoms in preterm infants with feed intolerance. METHODS: Sixteen preterm infants (gestational age 24-35 weeks) with feed intolerance were enrolled in the study. Infants were randomized to receive 7 days of cisapride 0.2 mg/kg four times a day, immediately followed by 7 days of placebo or vice versa. Gastric emptying was measured using the [13C]-octanoic acid breath test prior to study entry and repeated on day 5, 6 or 7 after randomization and 5, 6 or 7 days after crossover. The symptoms of GOR were monitored during the study period using a standardized reflux chart. Weight was recorded daily. RESULTS: There was no change in gastric emptying in infants prescribed cisapride (gastric half-emptying time (t1/2) 31.9 +/- 4.7 vs 34.2 +/- 3.9 min for placebo vs cisapride, respectively; P = 0.65). Infants on cisapride had slower growth and there was no change in reflux symptoms. CONCLUSIONS: The use of cisapride in preterm infants with feed intolerance cannot be recommended.
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