A prospective investigation into the role of therapeutic hypothermia on medication metabolism and excretion in newborns with perinatal resuscitation.
Completed
- Conditions
- perinatal asphyxia, therapeutic hypothermia, pharmacokinetics, pharmacodynamics.Dutch:perinatale asfyxie, therapeutische hypothermie, farmacokinetiek/ farmacodynamiek.
- Registration Number
- NL-OMON28126
- Lead Sponsor
- performers:Academic Medical Center / Emma Childrens Hospital (Amsterdam)UMCU/ Wilhelmina Childrens Hospital (Utrecht)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 270
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;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method This project aims to develop an evidence based effective and safe dosing regimen for commonly used life saving medications used in the treatment of asphyxiated, critically ill newborns, undergoing therapeutic hypothermia.
- Secondary Outcome Measures
Name Time Method Assessment of possible correlations between medication use during neuroprotective hypothermia and long term neurodevelopmental outcome.