Protocol Article - (2018) Volume 8, Issue 1
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 Favié1,2*, Cacha Peeters-Scholte3, Huibert Tjabbes3, Peter Vis4, Toine CG Egberts1,5, Frank Van Bel2,6, Carin MA Rademaker1 and Floris Groenendaal2,6
- 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, University Medical Center Utrecht, Utrecht, The Netherlands
Email:
Abbreviations
HIE: Hypoxic-Ischemic Encephalopathy; NDMA: N-methyl D-aspartate; NOS: Nitric Oxide Synthase; 2-IB: 2- Iminobiotin; NICU: Neonatal Intensive Care Unit; PK: Pharmacokinetic; DSMB: Data and Safety Monitoring Board; LC/MSMS: Liquid Chromatography-Mass Spectrometry; NONMEN: Nonlinear Mixed Effects Modelling; AUC: Area under the Concentration Time Curves; aEEG: Amplitude-Integrated Electroencephalography; CRF: Case Report Form; CRA: Clinical Research Associate.
Copyright: This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.