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入排标准

•1.Neonates with ≥ 36 and <44 weeks gestation who are eligible to receive therapeutic hypothermia.
•2.Ability to start treatment within 12 hours after birth.

•1.Inability to insert an indwelling catheter (umbilical venous catheter or percutaneously inserted central catheter, preferably multiple lumen) for administration of the drug or an arterial line for recurrent blood sampling.
•2.Major congenital malformations, specifically malformations that may affect the renal function.

2-STEP: A single-centre, phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-Iminobiotin (2-IB) in neonates with gestational age of ¡Ý36 weeks with moderate to severe perinatal asphyxia treated with therapeutic hypothermia

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