Abstract 1705 Poster Session III, Monday, 5/3 (poster 82)

Aim: The present study evaluates whether prophylactic use of cisapride will reduce the incidence of feed intolerance and gastro-esophageal reflux, and improve gastric emptying in early neonatal period in preterm babies. Method: The study was conducted as a double blind randomized controlled trial. Feed intolerance was judged by increase in abdominal girth, increased prefeed residuals or vomiting. Gastro-esophageal reflux and gastric emptying time was assessed by Technetium phytate scan. Preterm neonates between 29-34 weeks of gestation were enrolled in the study once they reached 30 ml/kg/day of enteral feeding or when 25 percent of total fluid intake was received through the enteral route. Babies with sepsis, congenital malformations and those on aminophylline were excluded. The subjects were randomized to receive either cisapride or placebo. During the study period babies were observed for clinical signs of feed intolerance. Technetium scan was done on day 7 ± 1 for measuring gastric emptying time and to detect gastro-esophageal reflux. Twenty two babies in each group were administered either cisapride (dose of 0.2 mg/kg/dose every 8 hours for 14 days or until discharge) or placebo. Results: Feed intolerance was noticed in 7.5 percent of study and 6 percent of control population. No significant difference was noticed in the two groups in the total number of episodes of feed intolerance (1.54 ± 2.4 vs. 1.18 ± 1.6 p value NS). Gastro-esophageal reflux was similar (about 50%) for both groups. Gastric emptying time was found to be comparable in those on drug and placebo (58 ± 32 min vs 54 ± 35 min, p=0.70). Conclusion: Cisapride does not reduce the incidence of feed intolerance, gastro-esophageal reflux and does not improve gastric emptying in normal preterm neonates. Considering the potential of toxicity of cisapride, the efficacy of its use in a neonatal population is questionable.