- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02002741
Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants
February 16, 2020 updated by: Rambam Health Care Campus
Adding Paracetamol to Ibuprofen for Treatment of Patent Ductus Arteriosus in Preterm Infants: A Pilot, Double Blind, Randomized, Placebo-control Trial
The purpose of this study is to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Randomized control trial to determine if adding paracetamol to ibuprofen is superior to ibuprofen only for treatment of patent ductus arteriosus (PDA) in preterm infants.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Haifa, Israel, 31096
- Rambam Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 days to 2 months (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Preterm infants born at 24-37 gestational age
- diagnosis of Hemodynamically significant patent ductus arteriosus
- Medical staff decided to treat with Ibuprofen
- Parents have signed informed consent
Exclusion Criteria:
- Contraindication for ibuprofen
- Alanine transaminase /Aspartate transaminase≥ 200 U/L
- Significant congenital heart disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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 |
Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h
Other Names:
|
PLACEBO_COMPARATOR: 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. |
Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of patent ductus arteriosus closure
Time Frame: 3-10 days after first dose of Ibuprofen + study drug
|
By echocardiography
|
3-10 days after first dose of Ibuprofen + study drug
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse effects
Time Frame: until discharge home (usually within 2-3 months since recruitment)
|
Renal and liver function, gastrointestinal complications will be assessed from the patient's medical records
|
until discharge home (usually within 2-3 months since recruitment)
|
The need for surgical ligation for PDA
Time Frame: 3-21 days after first dose of Ibuprofen + study drug
|
need for surgical ligation for PDA
|
3-21 days after first dose of Ibuprofen + study drug
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2014
Primary Completion (ACTUAL)
May 31, 2017
Study Completion (ACTUAL)
December 31, 2017
Study Registration Dates
First Submitted
November 24, 2013
First Submitted That Met QC Criteria
December 1, 2013
First Posted (ESTIMATE)
December 6, 2013
Study Record Updates
Last Update Posted (ACTUAL)
February 18, 2020
Last Update Submitted That Met QC Criteria
February 16, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBUACA CTIL
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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