NL-OMON33059CompletedNot Applicable
Study on Hypothermia-Induced Variations in pharmacokinetic Effect Relationships - SHIVER
niversitair Medisch Centrum Utrecht0 sites60 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 2 to 11 (—)
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
Investigators
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