Pharmacokinetics and Pharmacodynamics of Medication in Asphyxiated Newborns During Controlled Hypothermia PharmaCool National Multicenter Study. - PharmaCool National Multicenter Study.

Academisch Medisch Centrum0 sites270 target enrollmentTBD

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: medication metabolism during the intensive care treatment of resuscitated newborns
Sponsor: Academisch Medisch Centrum
Enrollment: 270
Status: Not yet recruiting
Last Updated: last year

No summary available.

Registry

who.int

Start Date

TBD

End Date

TBD

Last Updated

last year

Study Type

Observational invasive

Sponsor

•Any newborn :;1\) with a gestational age \> 36 weeks and a birth weight \> 3 kg;
•2\) with Apgar Score at 5 minutes postnatal \< 5;
•3\) with continued resuscitation at 10 minutes postnatally;
•4\) with 1 hour postnatal bloodgas analysis with pH \< 7\.0 or base deficit \> 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.

•1\) congenital hepatic or renal pathology (as this makes interpretation of PKPD results impossible);
•2\) without central venous line or arterial bloodstream access for blood sampling;
•3\) without written parental consent to participate following informed consent interview.