ROLE OF CISAPRIDE IN TREATMENT OF INFANTILE COLIC

西沙必利在治疗婴儿绞痛中的作用

• 批准号: 6122848
• 负责人: DAVID A WIECHMANN
• 金额: $ 3.03万
• 依托单位: CINCINNATI CHILDRENS HOSP MED CTR
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6122848
• 关键词: cisapride; clinical research; cryings; gastrointestinal disorder chemotherapy; human subject; human therapy evaluation; infant human (0-1 year); infant nutrition disorder; pain

The current proposal is a randomized, placebo-controlled, double-blinded crossover trial to determine the efficacy of cisapride, a gastrointestinal prokinetic, for the treatment of infantile colic. During the study period, parents keep crying time logs. Results of initial statistical analysis failed to show significant differences between cisapride (0.87 +/- 1.49 hours [mean ISD] and placebo (1.36 +/- 1.33 hours) or parental subjective rating. To show efficacy an extremely large sample size would be required suggesting minimal drug efficacy. During this study period 18 subjects were enrolled and the study terminated.

目前的提案是一项随机、安慰剂对照、双盲的研究 交叉试验以确定西沙必利（一种胃肠道药物）的功效 促动力，用于治疗婴儿绞痛。 学习期间 期间，父母不断记录哭泣的时间。 初步统计结果 分析未能显示西沙必利之间的显着差异（0.87 +/- 1.49 小时 [平均 ISD] 和安慰剂（1.36 +/- 1.33 小时）或父母 主观评价。 为了显示功效，需要极大的样本量 需要表明药物疗效最小。 在本研究期间 18 受试者被招募并且研究终止。