Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
NCT ID: NCT04397913
Last Updated: 2020-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2020-05-25
2023-05-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment(paracetamol or ibuprofen)
Paracetamol and ibuprofen are administered at standard dose for children with PDA.
Paracetamol
15 mg/kg, q6h
Ibuprofen
10 mg/kg qd for the 1st day, 5 mg/kg qd for the 2nd and 3rd day
Interventions
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Paracetamol
15 mg/kg, q6h
Ibuprofen
10 mg/kg qd for the 1st day, 5 mg/kg qd for the 2nd and 3rd day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: postnatal age ≤ 28 days;
* Paracetamol or ibuprofen used as part of regular treatment;
* Paracetamol or ibuprofen was administered orally.
Exclusion Criteria
* Patients with other heart diseases;
* Other factors that the researcher considers unsuitable for inclusion.
28 Days
ALL
No
Sponsors
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West China Second University Hospital
OTHER
Shandong University
OTHER
Responsible Party
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Wei Zhao
Professor; Head of department of clinical pharmacy and pharmacology
Locations
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West China Second University Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2020paracetamol-ibuprofen001
Identifier Type: -
Identifier Source: org_study_id
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