NL-OMON28126
Completed
Not Applicable
Pharmacokinetics and Pharmacodynamics of Medication in Asphyxiated Newborns During Controlled Hypothermia.<br><br>PharmaCool National Multicenter Study.
performers:Academic Medical Center / Emma Childrens Hospital (Amsterdam)UMCU/ Wilhelmina Childrens Hospital (Utrecht)0 sites270 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- perinatal asphyxia, therapeutic hypothermia, pharmacokinetics, pharmacodynamics.Dutch:perinatale asfyxie, therapeutische hypothermie, farmacokinetiek/ farmacodynamiek.
- Sponsor
- performers:Academic Medical Center / Emma Childrens Hospital (Amsterdam)UMCU/ Wilhelmina Childrens Hospital (Utrecht)
- Enrollment
- 270
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
/A
Investigators
Eligibility Criteria
Inclusion Criteria
- •Any newborn :
- •1\. With a gestational age \> 36 weeks and a birth weight \> 3 kg;
Exclusion Criteria
- •1\. Congenital hepatic or renal pathology (as this makes interpretation of PKPD results impossible);
- •2\. Without central venous line and arterial bloodstream access for blood sampling;
Outcomes
Primary Outcomes
Not specified
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