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

这个子项目是众多研究子项目之一

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.