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.
Phase 1
- Conditions
- Perinatal asphyxiaMedDRA version: 19.0Level: LLTClassification code 10003500Term: Asphyxia neonatalSystem Organ Class: 100000004855MedDRA version: 19.0Level: LLTClassification code 10004943Term: Birth asphyxiaSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2014-004265-25-NL
- Lead Sponsor
- niversity Medical Centre Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method