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

Journal of Clinical Trials
Open Access

ISSN: 2167-0870

+44 20 3868 9735

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: [email protected]
2Department of Neonatology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands, E-mail: [email protected]
3Neurophyxia B.V’s, Hertogenbosch, The Netherlands, E-mail: [email protected]
4LAP&P Consultants BV, Leiden, The Netherlands, E-mail: [email protected]
5Department of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht University, Utrecht, The Netherlands, E-mail: [email protected]
6Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands, E-mail: [email protected]
*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.



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