Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants
NCT ID: NCT02002741
Last Updated: 2020-02-18
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
24 participants
INTERVENTIONAL
2014-08-01
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Randomized Controlled Trial to Evaluate the Safety and Efficacy of Acetaminophen in Preterm Infants Used in Combination With Ibuprofen for Closure of the Ductus Arteriosus
NCT03701074
Paracetamol Versus Ibuprofen for PDA Closure
NCT03265782
Paracetamol in Patent Ductus Arteriosus
NCT02422966
Paracetamol and Patent Ductus Arteriosus (PDA)
NCT01291654
Addition of Acetaminophen in Standard PDA Management
NCT04026464
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ibuprofen + Paracetamol
Ibuprofen 10mg/kg once --\> 5mg/kg twice, q 24h for total of 3 doses
\+ Intravenous Paracetamol : Loading dose 20mg/kg --\> 10 mg/kg q6h for total of 12 doses
Paracetamol
Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h
Ibuprofen + Placebo
Ibuprofen 10mg/kg once --\> 5mg/kg twice, q 24h for total of 3 doses
\+ Placebo (NaCl 0.9%) , Intravenous , at equal volume to the paracetamol in the paracetamol arm, total of 12 doses given q 6h.
Placebo
Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Paracetamol
Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h
Placebo
Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* diagnosis of Hemodynamically significant patent ductus arteriosus
* Medical staff decided to treat with Ibuprofen
* Parents have signed informed consent
Exclusion Criteria
* Alanine transaminase /Aspartate transaminase≥ 200 U/L
* Significant congenital heart disease
2 Days
2 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rambam Health Care Campus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rambam Medical Center
Haifa, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IBUACA CTIL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.