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: 6116876
• 负责人: GILBERTO R PERRIERA
• 金额: $ 2.47万
• 依托单位: CHILDREN'S HOSP OF PHILADELPHIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6116876
• 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价长期使用 链多不饱和脂肪酸（LCP）补充早产儿SMA 婴儿。本研究是一项双盲、随机、对照、多中心研究。 中心前瞻性研究。患者作为住院患者进行研究， 门诊病人 自上次批准以来，我们共入组了5例患者， 完成了研究方案的住院阶段。这些患者 继续作为门诊患者接受研究，并完成参与 截至1997年3月，在他们的12个月的评估研究。 我们没有遇到与抽血有关的并发症， 注意到对任何研究配方的喂养不耐受的任何迹象。所有 5名患者生长正常，参数在 生长图的25和75英寸，校正了早产。