Abstract 43

Aims: To determine if Cisapride treatment (1) reduces the time to full enteral feeds (2) reduces gastro-oesophageal reflux, and (3) has more frequent side-effects. Methods: Infants <35 weeks gestation were randomised to receive oral Cisapride or placebo on starting enteral feeds. The following data were obtained: (1) time taken to reach full enteral feeds (2) rate of weight gain (3) gastric aspirate volumes (4) stool frequency (5) peak bilirubin level (6) QTc interval times and (7) measures of gastro-oesophageal reflux, using 24 hour pH monitoring. Results: Fourteen infants (7 Cisapride, 7 placebo) had been randomised when the trial was terminated by the Medicines Control Agency. The 2 groups were similar with respect to birthweight, gestation, sex, feed type and severity of illness. There were no differences in time to full enteral feeds, average weight gain, time to regain birthweight or QTc interval times. Maximum bilirubin levels were 200 ± 37 µmols/l (cisapride) vs 219± 26 µmols/l (control), NS. Stool frequency (per day) during the study was 2.5 ± 1 (cisapride) vs 2.5 ± 0.8 (control), NS. Gastro-oesophageal reflux scores in the second treatment week are shown below. Table

Table 1
Full size table

Conclusions: Although this is a small study, Cisapride appears to have no significant side-effects and may reduce gastro-oesophageal reflux. A larger study is required.