Study on Hypothermia-Induced Variations in pharmacokinetic Effect Relationships

Study on Hypothermia-Induced Variations in pharmacokinetic Effect Relationships - SHIVER

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33059

Enrollment

Registered

2009-06-30

Start date

2009-11-26

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

therapeutic hypothermia

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: Gestation >= 36 weeks;AND - Perinatal asphyxia with Apgar 5 min 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

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

Design outcomes

Primary

Measure	Time frame
PK-population profiles of midazolam, morphine, phenobarbitone and lidocaine.	—

Countries

Netherlands

Outcome results