Patent Ductus ArteriosusNCT04397913
Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Children With PDA
An observational study of Patent Ductus Arteriosus, run by Shandong University at 1 site in China.
Trial summary
The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- Paracetamol and Ibuprofen
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2020to 6 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: Neonates with patent ductus arteriosus
Who may be able to join
- Patients have been diagnosed with PDA;
- Age: postnatal age ≤ 28 days;
- Paracetamol or ibuprofen used as part of regular treatment;
- Paracetamol or ibuprofen was administered orally.
Who cannot join
- Patients who die within the treatment cycle;
- Patients with other heart diseases;
- Other factors that the researcher considers unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Second University Hospital
Chengdu, Sichuan, 610041
Wei Zhao, Ph.D, 86053188383308, zhao4wei2@hotmail.com
About this study
Official title: Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Preterm Neonates and Infants With Patent Ductus Arteriosus
The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization.
Read the detailed description
The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization. In this study, the investigator will detect drug concentration in plasma and other clinical test to construct population pharmacokinetic models.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- Paracetamol, Ibuprofen
- Medical subject headings
- Ductus Arteriosus, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Acetaminophen
15 mg/kg, q6h
IbuprofenDrug
10 mg/kg qd for the 1st day, 5 mg/kg qd for the 2nd and 3rd day
| Study group | Role | What they receive |
|---|---|---|
| Treatment(paracetamol or ibuprofen) | Paracetamol and ibuprofen are administered at standard dose for children with PDA. Receives: Drug: Paracetamol; Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma drug concentration of paracetamol
To detect the plasma concentration of paracetamol after administration
Measured: at (0-1) hour, (1-3) hours, (3-5) hours, (5-6) hours after oral administration
Plasma drug concentration of ibuprofen
To detect the plasma concentration of ibuprofen after administration
Measured: at (0-1.5) hours, (1-4) hours, (4-12) hours,(12-24) hours after oral administration
Echocardiography
To measure arterial duct diameter, shunt speed and direction of shunt
Measured: Through study completion, an average of 3 days
Cardiac function
To detect brain natriuretic peptide(BNP) and troponin T(cTnT)
Measured: Through study completion, an average of 3 days
Secondary outcomes (1)
Adverse events
Drug-related adverse events and serious adverse events
Measured: Through study completion, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start25 May 2020 (estimated)
- Primary completion30 Jan 2023 (estimated)
- Study completion6 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patent Ductus ArteriosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- West China Second University Hospital
- Responsible party
- Principal investigator, Wei Zhao, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04397913
- Sponsor's protocol ID
- 2020paracetamol-ibuprofen001
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics and Dosage Individualization of Paracetamol and Ibuprofen in Preterm Neonates and Infants With Patent Ductus Arteriosus
- ClinicalTrials.gov ID
- NCT04397913
- Acronym / sponsor ID
- 2020paracetamol-ibuprofen001
- Conditions
- Patent Ductus Arteriosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- West China Second University Hospital
- Study start
- 25 May 2020 (estimated)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 6 May 2023 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization.
Detailed description
The investigator's purpose is to study the population pharmacokinetics of paracatamol and ibuprofen in neonates with patent ductus arteriosus (PDA) and assess the feasibility of dosage individualization. In this study, the investigator will detect drug concentration in plasma and other clinical test to construct population pharmacokinetic models.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment(paracetamol or ibuprofen) | – | Drug: Paracetamol, Drug: IbuprofenParacetamol and ibuprofen are administered at standard dose for children with PDA. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Neonates with patent ductus arteriosus
Key inclusion criteria (4 listed)
- Patients have been diagnosed with PDA;
- Age: postnatal age ≤ 28 days;
- Paracetamol or ibuprofen used as part of regular treatment;
- Paracetamol or ibuprofen was administered orally.
Key exclusion criteria (3 listed)
- Patients who die within the treatment cycle;
- Patients with other heart diseases;
- Other factors that the researcher considers unsuitable for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: Acetaminophen15 mg/kg, q6h | Drug | Treatment(paracetamol or ibuprofen) |
| Ibuprofen10 mg/kg qd for the 1st day, 5 mg/kg qd for the 2nd and 3rd day | Drug | Treatment(paracetamol or ibuprofen) |
Primary outcome
Plasma drug concentration of paracetamol
Time frame: at (0-1) hour, (1-3) hours, (3-5) hours, (5-6) hours after oral administration
To detect the plasma concentration of paracetamol after administration
Plasma drug concentration of ibuprofen
Time frame: at (0-1.5) hours, (1-4) hours, (4-12) hours,(12-24) hours after oral administration
To detect the plasma concentration of ibuprofen after administration
Echocardiography
Time frame: Through study completion, an average of 3 days
To measure arterial duct diameter, shunt speed and direction of shunt
Cardiac function
Time frame: Through study completion, an average of 3 days
To detect brain natriuretic peptide(BNP) and troponin T(cTnT)
1 secondary outcome
Adverse events
Time frame: Through study completion, an average of 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhao, Ph.D (053188383308, zhao4wei2@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma drug concentration of paracetamol (time frame: at (0-1) hour, (1-3) hours, (3-5) hours, (5-6) hours after oral administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.