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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 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。具体地说，这项研究正在寻找在婴儿准备开始喂养之前给他们肌醇的最佳剂量。 以前对早产儿的研究表明，早产后第一周，血液中肌醇的水平会迅速下降。肌醇对正常的细胞功能和帮助身体器官发育和成熟很重要。婴儿在出生前[通过血液]从母亲那里获得肌醇，出生后从母亲的乳汁中获得肌醇。肌醇现在被添加到给早产儿喂养的配方奶粉中，因为研究表明，如果婴儿不吃东西，或者喂了没有添加肌醇的配方奶粉，肌醇水平在出生第一周后会逐渐下降。研究还表明，在早产儿中保持稳定的肌醇水平可能会减少某些眼病和肺部疾病。这项研究是在婴儿还没有准备好母乳或配方奶喂养的情况下，通过静脉注射肌醇后血液中肌醇的水平，因为还不知道肌醇的最佳剂量是多少。在知道了给早产儿服用肌醇的最佳剂量后，研究人员计划进行一项大型研究，从出生起直到婴儿足月。FDA还没有批准肌醇通过静脉给婴儿服用。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肌醇通过静脉给药。

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.