Study on Hypothermia-Induced Variations in pharmacokinetic Effect Relationships

Completed

• Conditions: therapeutic hypothermia; therapeutische koeling; 10014623; 10028920

• Registration Number: NL-OMON33059
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Gestation >= 36 weeks;AND
- Perinatal asphyxia with Apgar 5 min <= 5 OR
- Resuscitation/ventilation during 10 minutes after birth OR
- pH < 7 and base-deficit > 16 mmol/L (cord blood or within 1 hour after birth in arterial or venous blood) OR
- lactate > 10 mmol/L L (cord blood or within 1 hour after birth in arterial or venous blood);AND encephalopathy (Thomson score > 7 after 1 and 3 hours after birth)

Exclusion Criteria

Infants expected to be > 6 hours of age at the time of starting cooling

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>PK-population profiles of midazolam, morphine, phenobarbitone and lidocaine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>