Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants (INS-1)
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age
About this trial
This is an interventional treatment trial for Infant, Newborn focused on measuring NICHD Neonatal Research Network, Pharmacokinetics, Inositol, Very Low Birth Weight (VLBW), Extremely Low Birth Weight (ELBW), Prematurity
Eligibility Criteria
Inclusion Criteria: 23 0/7 to 26 6/7 weeks gestational age (36 infants) or 27 0/7 to 29 6/7 weeks gestational age (36 infants) 600-1500 grams birth weight No enteral feedings since birth at enrollment 3-6 days (25-132 hours) postnatal age Note: Because of the high mortality expected in this population (15-20%), the study design (originally for 72 infants) required recruitment of a replacement subject if any infant failed to complete the four blood samples during the first week of the study. Exclusion Criteria: Major congenital anomalies Moribund or not to be provided continued support Renal failure suspected (creatinine >2.5 with oliguria) Exchange transfusion received or expected to receive
Sites / Locations
- Yale University
- Indiana University
- Wayne State University
- University of New Mexico
- University of Rochester
- RTI International
- Duke University
- Case Western Reserve University, Rainbow Babies and Children's Hospital
- Brown University, Women & Infants Hospital of Rhode Island
- University of Texas Southwestern Medical Center at Dallas
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Inositol low volume
Inositol high volume
Placebo low volume
Placebo high volume
Single dose of intravenous inositol 5%, 60 mg/kg (1.2ml/kg) given over 20 minutes
Single dose of intravenous inositol 5%, 120 mg/kg (2.4ml/kg) given over 20 minutes
Placebo (5% glucose) at a volume equal to 60 mg/kg (1.2 ml/kg) given via IV over 20 minutes.
Placebo (5% glucose) at a volume equal to 120 mg/kg (2.4 ml/kg) given via IV over 20 minutes