PHASE II RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED SAFETY AND PHARMACOKINETIC

II 期随机、双盲、安慰剂对照安全性和药代动力学

• 批准号: 7952061
• 负责人: KRISTI L. WATTERBERG
• 金额: $ 0.48万
• 依托单位: UNIVERSITY OF NEW MEXICO
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-12-01 至 2009-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7952061
• 关键词: Birth; Blood; Blood Circulation; Cell physiology; Clinical Research; Computer Retrieval of Information on Scientific Projects Database; Dose; Double-Blind Method; Drops; Drug Kinetics; Eating; Eye; Eye Development; Funding; Grant; Human Milk; Infant; Inositol; Institution; Lung diseases; Milk; Mothers; New Mexico; Normal Cell; Organ; Phase; Placebo Control; Premature Birth; Premature Infant; Randomized; Research; Research Personnel; Resources; Safety; Source; United States National Institutes of Health; Universities; Veins; Vitamin B Complex; dietary supplements; falls; feeding

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This research is studying a dietary supplement called Inositol, which is part of the Vitamin B complex and is important for the development of the eyes. Specifically, this study is looking for the best dose of Inositol to give babies before they are ready to start taking feedings. Previous studies in premature infants have shown that blood levels of Inositol drop quickly in the first week after premature birth. Inositol is important for normal cell functioning and to help body organs grow and mature. Infants receive Inositol from their mother before they are born [through their bloodstream] and from their mother's milk after they are born. Inositol is now added to the formula that is fed to premature infants, because studies have shown that the Inositol levels fall gradually after the first week of birth if the infant is not eating, or is fed formula that does not have Inositol added. Studies have also shown that keeping steady levels of Inositol in premature infants may decrease certain eye and lung diseases. This study is looking at the level of Inositol in the blood after giving inositol through a vein when a baby is not ready to be fed breast milk or formula, because it is not known how much Inositol is the best dose. When the best dose of Inositol to give to premature babies is known, the investigators plan to do a large study to give Inositol from birth until a baby is full term. The FDA has not yet approved for Inositol to be given through a vein to infants. This study, and the large study to follow, will give information to the FDA to decide if they should approve Inositol to be given through a vein.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 这项研究正在研究一种名为肌醇的膳食补充剂，它是维生素B复合体的一部分，对眼睛的发育很重要。具体来说，这项研究正在寻找最佳剂量的肌醇给婴儿之前，他们准备开始采取喂养。 以前对早产儿的研究表明，血液中的肌醇水平在早产后的第一周迅速下降。 肌醇对正常细胞功能和帮助身体器官生长和成熟很重要。婴儿在出生前（通过血液）从母亲那里获得肌醇，并在出生后从母乳中获得肌醇。肌醇现在被添加到喂养早产儿的配方奶粉中，因为研究表明，如果婴儿不吃东西，或者喂养的配方奶粉没有添加肌醇，那么肌醇水平在出生后第一周就会逐渐下降。研究还表明，早产儿保持稳定的肌醇水平可能会减少某些眼部和肺部疾病。这项研究是在婴儿还没有准备好喂母乳或配方奶粉时，通过静脉注射肌醇后，观察血液中肌醇的水平，因为目前还不知道多少肌醇是最佳剂量。 当知道早产儿服用肌醇的最佳剂量时，研究人员计划进行一项大型研究，从婴儿出生到足月给予肌醇。FDA还没有批准肌醇通过静脉给婴儿。这项研究以及随后的大型研究将为FDA提供信息，以决定他们是否应该批准通过静脉给予肌醇。