Short Term Safety and Pharmacokinetics of the Selective NOS Inhibitor 2-Iminobiotin in Asphyxiated Neonates during Therapeutic Hypothermia: Protocol for the 2-STEP Study

Laurent MA Favié^1,2*, Cacha Peeters-Scholte³, Huibert Tjabbes³, Peter Vis⁴, Toine CG Egberts^1,5, Frank Van Bel^2,6, Carin MA Rademaker¹ and Floris Groenendaal^2,6

¹Department of Clinical Pharmacy, University Medical Center Utrecht, Utrecht, The Netherlands, E-mail: l.m.a.favie@umcutrecht.nl

²Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands, E-mail: l.m.a.favie@umcutrecht.nl

³Neurophyxia B.V’s, Hertogenbosch, The Netherlands, E-mail: l.m.a.favie@umcutrecht.nl

⁴LAP&P Consultants BV, Leiden, The Netherlands, E-mail: l.m.a.favie@umcutrecht.nl

⁵Department of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht University, Utrecht, The Netherlands, E-mail: l.m.a.favie@umcutrecht.nl

⁶Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands, E-mail: l.m.a.favie@umcutrecht.nl

^*Corresponding Author: Laurent MA Favié, Department of Clinical Pharmacy