Patent Ductus ArteriosusNCT01511887
Safety and Efficacy of Ibuprofen in Term Newborns With Patent Ductus Arteriosus (PDA)
A study testing Oral Ibuprofen in people with Patent Ductus Arteriosus, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial summary
The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011. Read more about this study
- Who is it for?
- Ages 20 to 28 days
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- Oral Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Jan 2011to Jan 2012
- Phase
- Interventional
- 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 20 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Term newborn (37 weeks of gestation or more)
- Age between 20-28 days
- confirmed diagnosis of PDA by echocardiography by pediatric cardiologist
Who cannot join
- Asphyxia
- Hemorrhage
- Platelet count < 150000
- renal or gastrointestinal malformations
- associated congenital heart disease
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan, 097145-3388
About this study
Official title: Evaluation of the Safety and Efficacy of Oral Ibuprofen in Term 20-28 Days Old Newborns Referred to Bandar Abbass Children Hospital in 2011
The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.
Read the detailed description
Patent Ductus Arteriosus (PDA) accounts for about 10% of Congenital Heart Disease. Surgical treatment in PDA is associated with higher rate of complication than pharmacologic treatment. Efficacy of Ibuprofen is shown in preterm and low birth weights newborn with PDA. Studies in term neonates after the first days of birth are rare. The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- Oral Ibuprofen
- Keywords
- Patent Ductus Arteriosus, PDA, Term newborns, 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.
Oral IbuprofenDrug
Also called Advil
10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated.
| Study group | Role | What they receive |
|---|---|---|
| Oral Ibuprofen | Experimental | 10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated. Receives: Drug: Oral Ibuprofen |
| No treatment | No intervention | No treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
PDA closure after 1 week
PDA closure after 1 week of treatment based on echocardiography
Measured: 1 weeks after treatment
PDA closure after two weeks
PDA closure two weeks after treatment based on echocardiography
Measured: 2 weeks after treatment
Secondary outcomes (1)
Drug side effects
hemorrhage, abdominal distention, oliguria
Measured: two weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionJan 2012
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamidreza Mahboobi, Hormozgan University of Medical Sciences
- Investigators
- Hamidreza Mahboobi, MD, Principal investigator, Hormozgan University of Medical Sciences (HUMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511887
- Sponsor's protocol ID
- Ibuprofen in PDA
- Status last verified
- Jan 2012
- First submitted
- 13 Jan 2012
- Last updated
- 20 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of Oral Ibuprofen in Term 20-28 Days Old Newborns Referred to Bandar Abbass Children Hospital in 2011
- ClinicalTrials.gov ID
- NCT01511887
- Acronym / sponsor ID
- Ibuprofen in PDA
- Conditions
- Patent Ductus Arteriosus
- Keywords
- Patent Ductus Arteriosus, PDA, Term newborns, Ibuprofen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 19 Jan 2012 (estimated)
- 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 aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.
Detailed description
Patent Ductus Arteriosus (PDA) accounts for about 10% of Congenital Heart Disease. Surgical treatment in PDA is associated with higher rate of complication than pharmacologic treatment. Efficacy of Ibuprofen is shown in preterm and low birth weights newborn with PDA. Studies in term neonates after the first days of birth are rare. The aim of current study is to evaluate the efficacy and safety of oral Ibuprofen in term 20-28 days old newborn referred to Bandarabbas children' hospital in 2011.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Ibuprofen | Experimental | Drug: Oral Ibuprofen10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated. |
| No treatment | No intervention | –No treatment |
Who may qualify
- Ages
- 20 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Term newborn (37 weeks of gestation or more)
- Age between 20-28 days
- confirmed diagnosis of PDA by echocardiography by pediatric cardiologist
Key exclusion criteria (5 listed)
- Asphyxia
- Hemorrhage
- Platelet count < 150000
- renal or gastrointestinal malformations
- associated congenital heart disease
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 |
|---|---|---|
| Oral IbuprofenAlso: Advil10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated. | Drug | Oral Ibuprofen |
Primary outcome
PDA closure after 1 week
Time frame: 1 weeks after treatment
PDA closure after 1 week of treatment based on echocardiography
PDA closure after two weeks
Time frame: 2 weeks after treatment
PDA closure two weeks after treatment based on echocardiography
1 secondary outcome
Drug side effects
Time frame: two weeks after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2012.
Related trials for Patent Ductus Arteriosus
Recruiting
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Congenital Heart Disease, Congenital Heart Disease (CHD)
Active, not recruiting
PREEMIE: Study for Treatment of PDA in Premature Infants
Patent Ductus Arteriosus (PDA)
Active, not recruitingObservational study
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
Patent Ductus Arteriosus
Active, not recruitingObservational study
PDA for Kidneys Study
Patent Ductus Arteriosus, Congenital Heart Disease
RecruitingPhase 2
Co-administration of Acetaminophen With Ibuprofen to Improve Duct-Related Outcomes in Extremely Premature Infants
Patent Ductus Arteriosus After Premature Birth
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.
Hamidreza Mahboobi, MD principal investigator
Hormozgan University of Medical Sciences (HUMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral Ibuprofen in people with Patent Ductus Arteriosus, run by Hormozgan University of Medical Sciences at 1 site in Iran.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 20 Jan 2012. 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 Iran. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PDA closure after 1 week (time frame: 1 weeks after treatment). The study lists 2 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 20 Jan 2012.