Phase II Randomized, Double Blind, Placebo Controlled, Safety and Pharmacokinetic Study of a Single Dose of Inositol in Premature Infants

Study ID
STU 052011-096

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Diana Vasil
214-648-3789
diana.vasil@utsouthwestern.edu

Principal Investigator
Myra Wyckoff

Summary

In this study, one infusion of inositol or placebo will be administered
intravenously at two different doses in a study of 72 extremely low gestational
age infants ([AND]amp;lt;30 weeks) under IND # 70,510. Blood and urine changes in
concentration of inositol will be measured and used to determine population
pharmacokinetic parameters for these infants. The blinded placebo group
provides data on the endogenous processing of inositol, and permits unbiased
recording of potential side effects. The results from this study will be used to
select the doses for the subsequent multi-dose pilot study, and for the planned
large multi-center trials.

Participant Eligibility


* Gestational age of 230/7 to 296/7 weeks (Network definition of GA)

* Birth weight of 600 -1500 grams

* Chronologic age is less than seven days

* Remains NPO since birth (and projected to be NPO at the time of infusion)