A double-blind placebo-controlled study to assess the effect of cisapride (PREPULSID) on milk feed tolerance in preterm infants -32 weeks gestation

ABSTRACT

Thirty-six premature infants with a mean birth weight of 1250 g and a gestation age of 28 weeks were enrolled in a randomised double-blind placebo controlled study to assess the effect of Cisapride on milk feed tolerance. Cisapride or placebo was given orally at a dose of 0.2 mg/kg/dose four times daily from the time feeds were commenced up to one week after full feeds (150 ml/kg/day) were attained. All infants were fed expressed breast milk (EBM) or Premature Enfalac every 2 hours and graded up by 1 ml every 2 hours via nasogastric tube (NGT). Six parameters were assessed during the study period to determine feed intolerance. Milk feed intolerance was defined as 2 major or 1 major plus 2 minor criteria. The major criteria included gastric aspirates 2 ml/kg or 30% of volume given at the last feed and bile-stained aspirates. The minor criteria included vomiting, abdominal distention, blood in stools, and reducing substances in stools 2%. The possible risks of cholestasis and the development of ECG changes were also evaluated in the treated group. Milk feed intolerance did not occur in the Cisapride group (0/18, 0%), but was present in 49% (7/18) of the placebo group (p+0.003). Cisapride significantly reduced the volume of gastric aspirates (p=0.025) and vomiting episodes (p=0.011) in the treated infants. No infant who received Cisapride developed cholestatic jaundice clinically nor manifested any abnormal ECG findings. We conclude that Cisapride is effective in improving milk feed intolerance in premature infants -32 weeks gestation and no evidence of cholestasis nor ECG changes were observed after treatments.(Author)