RT Book, Section A1 Turner, Kevin N. A1 Smith, P. Brian A2 Lopes, Renato D. A2 Harrington, Robert A. SR Print(0) ID 57836104 T1 Chapter 9. Challenges of Clinical Trials in Pediatrics T2 Understanding Clinical Research YR 2013 FD 2013 PB The McGraw-Hill Companies PP New York, NY SN 978-0-07-174678-6 LK accessmedicine.mhmedical.com/content.aspx?aid=57836104 RD 2024/03/29 AB Cisapride was a medication approved by the US Food and Drug Administration (FDA) in 1993 for nighttime heartburn in adults. It was never shown to be effective or safe in children under the age of 16 and therefore had no FDA approval for use in this population (1,2). However, cisapride quickly found a market treating a common neonatal problem, gastroesophageal reflux (GER). There was a flavored syrup formulation that was labeled for use in geriatrics, but 90% of its sales were for use in pediatric patients (3). Hospitalized preterm infants also receive medications for symptoms thought to be associated with GER, including apnea, bradycardia, coughing, choking, and cyanosis (4,5). By 1998, more than 19% of infants in neonatal intensive care units (NICUs) in the United States were receiving cisapride (4).