perinatal asphyxia, therapeutic hypothermia, pharmacokinetics, pharmacodynamics. Dutch: perinatale asfyxie, therapeutische hypothermie, farmacokinetiek/ farmacodynamiek.
Conditions
Interventions
None listed
Sponsors
performers:
Academic Medical Center / Emma Childrens Hospital (Amsterdam)
UMCU/ Wilhelmina Childrens Hospital (Utrecht)
Eligibility
Inclusion criteria
Inclusion criteria: Any newborn : 1. With a gestational age > 36 weeks and a birth weight > 3 kg; 2. With Apgar Score at 5 minutes postnatal 16; 5. With clinical signs of moderate to severe encephalopathy (defined as a Thomson score of >7 or a Sarnat score of >1); 6. Who is undergoing neuroprotective treatment by controlled hypothermia < 6 hours postnatally.
Exclusion criteria
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; 3. Without written parental consent to participate following informed consent interview.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Assessment of possible correlations between medication use during neuroprotective hypothermia and long term neurodevelopmental outcome. | — |
Contacts
Public ContactT.R. Haan, de
Meibergdreef 9
Outcome results
None listed