Pharmacokinetics and pharmacodynamics of Acetaminophen in neonates.
Completed
- Conditions
- eonates, Paracetamol intravenous, Pharmakokinetics, Pharmacodynamics
- Registration Number
- NL-OMON24744
- Lead Sponsor
- Erasmus Medical center, Sophia Children's Hospital
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1. Neonates (in- and outborn) with a gestational age of 24-42 weeks;
2. Admission within the first 24 hours of life;
Exclusion Criteria
1. Major congenital anomalies;
2. Intraventriculair haemorrhage > grade 2;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic properties of Acetaminophen in neonates: Safety and Efficacy Profile: Determine optimal loading dose of Acetaminophen in different age-subgroups. <br><br /><br /><br>1. Safety outcome parameters are:<br /><br>A. Acetaminophen serum levels;<br /><br>B. Acetaminophen metabolite levels in urine samples;<br /><br>C. Renal function;<br /><br>D. Hepatotoxicity (determine NAPQ1levels as indicator).<br /><br>2. Pharmacodynamic properties of Acetaminophen in neonates: Comfortneo score and PIPP as pain assessment tools used in the different dose regimens of acetaminophen.<br>
- Secondary Outcome Measures
Name Time Method Registration and/or drug interaction:<br /><br>1. Influence of drugs metabolised by cytochrome P-450 on serum levels of acetaminophen: indomethacin; <br /><br>2. Influence of acetaminophen on indomethacin-treatment of PDA closure;<br /><br>3. Influence of acetaminophen on bilirubin glucuronidation.