TRIAL OF PREEMIE SMA SUPPLEMENTED WITH LONG CHAIN POLYUNSATURATED FATTY ACIDS

补充长链多不饱和脂肪酸的早产儿 SMA 试验

• 批准号: 6278071
• 负责人: GILBERTO R PERRIERA
• 金额: $ 2.4万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-12-01 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6278071
• 关键词: baby food; child physical development; clinical research; clinical trials; developmental nutrition; diet therapy; dietary supplements; human subject; human therapy evaluation; long chain fatty acid; longitudinal human study; nutrition related tag; outcomes research; premature infant human; unsaturated fatty acids

The primary objective of this study is to evaluate the safety of long chain polyunsaturated fatty acid (LCP) supplemented preemie SMA in preterm infants. This study is a double-blind, randomized, controlled, multi- center prospective study. Patients were studied as both inpatients and outpatients. Since the last approval, we have enrolled a total of 5 patients who completed the in-hospital phase of the study protocol. These patients continued to be studied as outpatients and completed their participation in the study as of March 1997, at their 12 month evaluation. We have encountered no complications related to blood drawing and have not noticed any signs of feeding intolerance to any of the study formulas. All five patients are growing appropriately with parameters falling within the 25 and 75 percentiles of the growth chart, corrected for prematurity.

本研究的主要目的是评估长