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 *36 weeks with moderate to severe perinatal asphyxia treated with therapeutic hypothermia

Phase 2

Completed

Conditions: neonatal asphyxia
oxygen shortage at birth
10010335

Registration Number: NL-OMON43724

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To explore the safety, tolerability and the pharmacokinetic profile of 2-IB<br /><br>when given on top of therapeutic hypothermia.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To gather preliminary signs of short term efficacy as defined by the Lac/NAA<br /><br>ratios using MRS at 3-7 days after birth and the percentage of surviving<br /><br>patients with a normal aEEG at 60h after birth.</p><br>