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

• Conditions: medication metabolism during the intensive care treatment of resuscitated newborns; 10010335; 10028920

• Registration Number: NL-OMON34433
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 270

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 < 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified