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Author Notes:

*Corresponding Author: Dale L Phelps, MD, Professor of Pediatrics, Pediatrics, Box 651, 601 Elmwood Ave, Rochester, NY 14642, Email: dale_phelps@urmc.rochester.edu, (707) 897-9063

We are indebted to the families who consented to take part in the study, and to our medical, nursing, pharmacy, and research coordinator colleagues (See Supplemental Acknowledgments).

[For further information on the funding support please refer to the post-print publication.]

DISCLOSURES: The authors report no commercial, proprietary, or financial interest in any of the products described in this article, nor any conflicts of interest.


Research Funding:

The National Institutes of Health and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Neonatal Research Network and the Pediatric Pharmacology Research Units Network, with co-funding from the National Eye Institute provided grant support for this trial, with additional support from the National Center for Research Resources, and the National Center for Advancing Translational Sciences, Bethesda, MD, USA.


  • Science & Technology
  • Life Sciences & Biomedicine
  • Pediatrics

Safety and pharmacokinetics of multiple dose myo-inositol in preterm infants

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Journal Title:

Pediatric Research


Volume 80, Number 2


, Pages 209-217

Type of Work:

Article | Post-print: After Peer Review


Background: Preterm infants with respiratory distress syndrome (RDS) given inositol had reduced bronchopulmonary dysplasia (BPD), death and severe retinopathy of prematurity (ROP). We assessed the safety and pharmacokinetics of daily inositol to select a dose providing serum levels previously associated with benefit, and to learn if accumulation occurred when administered throughout the normal period of retinal vascularization. Methods: Infants ≤ 29 wk GA (n = 122, 14 centers) were randomized and treated with placebo or inositol at 10, 40, or 80 mg/kg/d. Intravenous administration converted to enteral when feedings were established, and continued to the first of 10 wk, 34 wk postmenstrual age (PMA) or discharge. Serum collection employed a sparse sampling population pharmacokinetics design. Inositol urine losses and feeding intakes were measured. Safety was prospectively monitored. Results: At 80 mg/kg/d mean serum levels reached 140 mg/l, similar to Hallman's findings. Levels declined after 2 wk, converging in all groups by 6 wk. Analyses showed a mean volume of distribution 0.657 l/kg, clearance 0.058 l/kg/h, and half-life 7.90 h. Adverse events and comorbidities were fewer in the inositol groups, but not significantly so. Conclusion: Multiple dose inositol at 80 mg/kg/d was not associated with increased adverse events, achieves previously effective serum levels, and is appropriate for investigation in a phase III trial.

Copyright information:

© 2016 International Pediatric Research Foundation, Inc.

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