P S Reddy1, A K Deorari, C S Bal, V K Paul, M Singh. 1. Departments of Pediatrics and Nuclear Medicine, All India Institute of Medical Sciences, Ansari Nagar, New Delhi 110 029, India.
Abstract
OBJECTIVE: To evaluate 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. DESIGN: Double blind randomized controlled trial. SETTING: Hospital based. SUBJECTS:Forty nine preterm babies between 29-34 weeks of gestation were administered either cisapride or placebo. METHODS: Babies were enrolled in the study once they reached 30 ml/kg/day of enteral feeding or when 25% of total fluid intake was received through the enteral route. Those with sepsis, congenital malformations and on aminophylline were excluded. The subjects were randomized to receive either cisapride or placebo in a dose of 0.2 mg/kg/dose every 8 hourly for 14 days or till discharge. During the study period babies were observed for clinical signs of feed intolerance as judged by increase in abdominal girth, increased prefeed gastric residuals or vomiting. Gastro-esophageal reflux and gastric emptying time was assessed by Technetium phytate scan on day 7 +/- 1. RESULTS:Feed intolerance was noticed in 59% of study and 41% 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). Nearly 50% of babies in each group had gastro-esophageal reflux. Gastric emptying time (mean (SD) and median) was found to be comparable (p = 0.70) in those on drug and placebo (58.1 (32.2 min) 48.8 min) vs (53.8 (34.6 min) 43.4 min). CONCLUSION:Cisapride does not reduce the incidence of feed intolerance, gastro-esophageal reflux and does not improve gastric emptying in normal preterm neonates.
RCT Entities:
OBJECTIVE: To evaluate 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. DESIGN: Double blind randomized controlled trial. SETTING: Hospital based. SUBJECTS: Forty nine preterm babies between 29-34 weeks of gestation were administered either cisapride or placebo. METHODS: Babies were enrolled in the study once they reached 30 ml/kg/day of enteral feeding or when 25% of total fluid intake was received through the enteral route. Those with sepsis, congenital malformations and on aminophylline were excluded. The subjects were randomized to receive either cisapride or placebo in a dose of 0.2 mg/kg/dose every 8 hourly for 14 days or till discharge. During the study period babies were observed for clinical signs of feed intolerance as judged by increase in abdominal girth, increased prefeed gastric residuals or vomiting. Gastro-esophageal reflux and gastric emptying time was assessed by Technetium phytate scan on day 7 +/- 1. RESULTS: Feed intolerance was noticed in 59% of study and 41% 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). Nearly 50% of babies in each group had gastro-esophageal reflux. Gastric emptying time (mean (SD) and median) was found to be comparable (p = 0.70) in those on drug and placebo (58.1 (32.2 min) 48.8 min) vs (53.8 (34.6 min) 43.4 min). CONCLUSION:Cisapride does not reduce the incidence of feed intolerance, gastro-esophageal reflux and does not improve gastric emptying in normal preterm neonates.