A study looking at 2-Iminobiotin as treatment for newborn children suffering from insufficient oxygen supply to the brain in addition to standard treatment with cooling.

Completed

Conditions: perinatal asphyxia - perinatale asfyxie

Registration Number: NL-OMON20368

Lead Sponsor: MC 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
Safety assessments include: vital signs, clinical laboratory parameters, clinical evaluation and (severe) adverse events and local tolerance.<br /><br /><br><br>Pharmacokinetic assessment: a maximum of five PK samples will be taken. The exact time points to determined before start of the study based on all data available at that moment.<br>The following pharmacokinetic parameters will be calculated for each patient, using the actual sampling times:<br /><br>• C-max (observed maximum plasma concentration)<br /><br>• AUC-0-6h (area under the plasma concentration-time curve from time 0 to 6h after administration)<br /><br>• AUC-0-∞ (area under the plasma concentration-time curve from time 0 to infinity)<br /><br>• T-end of infusion (time at maximum plasma concentration).<br /><br>•t1/2 (terminal elimination half-life)<br /><br>•CL (clearance)<br /><br>•Vd (volume of distribution)

Secondary Outcome Measures

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