Patent Ductus ArteriosusNCT01261117
Efficacy and Safety of Oral Versus Intravenous Ibuprofen for PDA Treatment in ELBW Infants
A study testing oral ibuprofen in people with Patent Ductus Arteriosus, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants. Read more about this study
- Who is it for?
- Ages 1 day to 7 days
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- oral ibuprofen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2009to Jun 2011
- 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 1 day to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birth weight below 1000 gram
- Diagnosed patent ductus arteriosis by Echocardiographic examination
Who cannot join
- Accompanied other congenital cardiac anomalies
- Severe thrombocytopenia < 60.000
- Severe intracranial bleeding (Grade 3-4)
- Intestinal abnormality and necrotising enterocolitis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zekai Tahir Burak Maternity Teaching Hospital
Ankara, 06600
About this study
Official title: Oral Versus Intravenous Ibuprofen Treatment
To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.
Read the detailed description
To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.Seventy ELBW preterm infants with patent ductus arteriosis will be enrolled in this prospective-randomized study. Patients will receive either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
One of the following echocardiographic criteria of a duct size >1.5 mm, a left atrium-to-aorta ratio >1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of ibuprofen treatment.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- oral ibuprofen
- Keywords
- Patent ductus arteriosis, İbuprofen, Extremely Low Birth Weigh infant
- 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
oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals
| Study group | Role | What they receive |
|---|---|---|
| intravenous ibuprofen | Active comparator | Extremely low birth weight patients receiving iv ibuprofen Receives: Drug: oral ibuprofen |
| Oral ibuprofen | Active comparator | Extremely low birth weight patients receiving oral ibuprofen Receives: Drug: oral ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575
To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment
Measured: 6 months
Secondary outcomes (1)
Efficacy and Safety of Oral Versus Intravenous Ibuprofen
Evaluation of renal tolerance and complications
Measured: Results will be identified in 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2010 (estimated)
- Study startJan 2009
- Primary completionApr 2011
- Study completionJun 2011
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Omer Erdeve, Study director, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261117
- Sponsor's protocol ID
- STO5336205575
- Status last verified
- Nov 2010
- First submitted
- 29 Nov 2010
- Last updated
- 9 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Versus Intravenous Ibuprofen Treatment
- ClinicalTrials.gov ID
- NCT01261117
- Acronym / sponsor ID
- STO5336205575
- Conditions
- Patent Ductus Arteriosus
- Keywords
- Patent ductus arteriosis, İbuprofen, Extremely Low Birth Weigh infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Dec 2010 (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.
To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.
Detailed description
To determine whether oral or intravenous ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosis in extremely-low-birth-weight preterm infants.Seventy ELBW preterm infants with patent ductus arteriosis will be enrolled in this prospective-randomized study. Patients will receive either intravenous or oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
One of the following echocardiographic criteria of a duct size >1.5 mm, a left atrium-to-aorta ratio >1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of ibuprofen treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous ibuprofen | Active comparator | Drug: oral ibuprofenExtremely low birth weight patients receiving iv ibuprofen |
| Oral ibuprofen | Active comparator | Drug: oral ibuprofenExtremely low birth weight patients receiving oral ibuprofen |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Birth weight below 1000 gram
- Diagnosed patent ductus arteriosis by Echocardiographic examination
Key exclusion criteria (4 listed)
- Accompanied other congenital cardiac anomalies
- Severe thrombocytopenia < 60.000
- Severe intracranial bleeding (Grade 3-4)
- Intestinal abnormality and necrotising enterocolitis
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 ibuprofenoral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals | Drug | Oral ibuprofen, intravenous ibuprofen |
Primary outcome
Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575
Time frame: 6 months
To compare the closure rate of patent ductus arteriosus after intravenous or oral ibuprofen treatment
1 secondary outcome
Efficacy and Safety of Oral Versus Intravenous Ibuprofen
Time frame: Results will be identified in 6 months
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 9 Aug 2011.
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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.
Omer Erdeve study director
Zekai Tahir Burak Women's Health Research and Education Hospital
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 Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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 9 Aug 2011. 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 Turkey (Türkiye). 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?
Efficacy and Safety of Oral Versus Intravenous Ibuprofen... ID: STO5336205575 (time frame: 6 months). 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 9 Aug 2011.