Randomised controlled trial of cisapride in preterm neonates for gastric emptying time

Editor—We read with interest the study on the randomised controlled trial of cisapride in preterm infants reported by by McClure et al.1We have recently concluded a randomised, double blind, placebo controlled study to evaluate the effect of cisapride on feed tolerance and gastric emptying of preterm neonates. (P S Reddy, A K Deorari, C S Bal, V K Paul, M Singh. Abstract 1705 presented to the Society of Pediatrics Research meeting, 1-4 May 1999, San Francisco, USA). After obtaining informed parental consent a total of 44 preterm neonates stratified by gestation into 29–32 weeks and 33–34 weeks, and randomly allocated to receive either cisapride or placebo at a dose of 0.2 mg/kg every 8 hours. The babies were enrolled once they were stable and receiving oral feeds amounting to 25 per cent of their fluid requirements.

The feeds were increased gradually in a stepwise manner, around 20 ml/kg/day. Gastric emptying time was measured on days 6 to 8 after enrolment using a dynamic technetium scan using 100 μCi of radioactivity. This results in only 0.2 mSV of whole body absorbed dose.2 To offset the effect of type of feeding on gastric emptying, the two feeds before the nuclear study were of uniformly expressed breast milk. Gastric emptying time (mean (SD) and median) in the cisapride group (58.1 (32.2 mins) 48.8 mins) was not significantly different from that of the control group (53.8 (34.6 mins) 43.4 mins). Clinically significant gastro-oesophageal reflux was seen in 50% of babies in each group. Cisapride had no effect on either the number of episodes of feed intolerance or the length of feed intolerance. Weight gain and the day on which the total enteral feeding began were also comparable in the two groups.

Our observations support the findings of McClure et al, that cisapride does not improve gastric emptying in preterm neonates and that its use for establishing enteral feeds is not warranted.