Patent Ductus ArteriosusPhase 2NCT01070745
Second Course of Therapy for Resistant Patent Ductus Arteriosus (PDA)
A Phase 2 study testing Indomethacin and Ibuprofen in people with Patent Ductus Arteriosus, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
Patency of the ductus arteriosus (PDA) is functionally essential for fetal circulation, however persistence of ductal patency postnatally may have significant adverse hemodynamic effects in the neonate. Read more about this study
- Who is it for?
- Ages 2 days to 2 months
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- Indomethacin and Ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Jun 2012
- Phase
- Phase 2
- 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 2 days to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inborn premature neonates (birth weight [BW] <1500 grams) being treated in the neonatal intensive care unit of the Shaare Zedek Medical Center and diagnosed as still having a hemodynamically significant patent ductus arteriosus (hsPDA) after a first course of therapy with indomethacin, will be considered as potential candidates for study pending response to initial therapy and pending parental consent.
Who cannot join
- Any baby not considered viable
- Any baby with intraventricular hemorrhage (IVH) grade 3-4 of recent onset (within 3 days). [If no head ultrasound has been performed within the last 3-4 days, one should be performed prior to onset of study.]
- Any baby with dysmorphic features or congenital abnormalities
- Any baby with structural heart disease other than PDA
- Any baby with documented infection,
- Any baby with thrombocytopenia (<50,000).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ibuprofen vs. Indomethacin as Second Course of Therapy for Resistant PDA in Low Birth Weight Neonates
Patency of the ductus arteriosus (PDA) is functionally essential for fetal circulation, however persistence of ductal patency postnatally may have significant adverse hemodynamic effects in the neonate. Medical therapy for PDA predominantly involves the administration of one of two non-steroidal anti-inflammatory drugs: indomethacin or ibuprofen. Both of these therapies have been shown to be successful in mediating ductal closure in approximately 70% of treated infants.
However, the need for a second course of treatment for PDA closure remains quite common. The investigators hypothesize that, because of small differences between the two drugs, a greater percentage of infants who did not respond to a first course of therapy with indomethacin will respond to a second course with ibuprofen than to a repeat course of indomethacin.
As such, the investigators aim to compare secondary therapy with a repeat course of indomethacin to secondary therapy with ibuprofen in infants whose ductus remained patent after a first course of therapy with indomethacin.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- Indomethacin, Ibuprofen
- Keywords
- PDA, Indomethacin, 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.
IndomethacinDrug
Also called Indomed
Three doses of intravenous (IV) indomethacin at 0.2 mg/kg/dose given over 30 minutes, at intervals of 12 hours
IbuprofenDrug
Also called Arfen
10 mg/kg infused over 30 minutes, followed by two doses of 5mg/kg each at 24 hour intervals
| Study group | Role | What they receive |
|---|---|---|
| Indomethacin for resistant PDA | Experimental | Treatment with second course of indomethacin Receives: Drug: Indomethacin |
| Ibuprofen for resistant PDA | Experimental | Ibuprofen as second course of therapy Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in ductal closure rates in those infants who do not respond to a first course of therapy
Measured: 2.5 years
Secondary outcomes (2)
More infants who did not respond to a first course of therapy with indomethacin who respond to a second course with ibuprofen than to a repeat course of indomethacin
Measured: 2.5 years
Secondary treatment with ibuprofen, as opposed to indomethacin, will not be associated with increased side effects
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012 (estimated)
Why it stopped: Changes in approach to PDA therapy
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Cathy Hammerman, MD, Principal investigator, Shaare Zedek Medical Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01070745
- Sponsor's protocol ID
- chammerman3
- Status last verified
- Feb 2010
- First submitted
- 17 Feb 2010
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ibuprofen vs. Indomethacin as Second Course of Therapy for Resistant PDA in Low Birth Weight Neonates
- ClinicalTrials.gov ID
- NCT01070745
- Acronym / sponsor ID
- chammerman3
- Conditions
- Patent Ductus Arteriosus
- Keywords
- PDA, Indomethacin, Ibuprofen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Changes in approach to PDA therapy
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (estimated)
- First posted
- 18 Feb 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.
Patency of the ductus arteriosus (PDA) is functionally essential for fetal circulation, however persistence of ductal patency postnatally may have significant adverse hemodynamic effects in the neonate. Medical therapy for PDA predominantly involves the administration of one of two non-steroidal anti-inflammatory drugs: indomethacin or ibuprofen. Both of these therapies have been shown to be successful in mediating ductal closure in approximately 70% of treated infants.
However, the need for a second course of treatment for PDA closure remains quite common. The investigators hypothesize that, because of small differences between the two drugs, a greater percentage of infants who did not respond to a first course of therapy with indomethacin will respond to a second course with ibuprofen than to a repeat course of indomethacin.
As such, the investigators aim to compare secondary therapy with a repeat course of indomethacin to secondary therapy with ibuprofen in infants whose ductus remained patent after a first course of therapy with indomethacin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indomethacin for resistant PDA | Experimental | Drug: IndomethacinTreatment with second course of indomethacin |
| Ibuprofen for resistant PDA | Experimental | Drug: IbuprofenIbuprofen as second course of therapy |
Who may qualify
- Ages
- 2 days to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Inborn premature neonates (birth weight [BW] <1500 grams) being treated in the neonatal intensive care unit of the Shaare Zedek Medical Center and diagnosed as still having a hemodynamically significant patent ductus arteriosus (hsPDA) after a first course of therapy with indomethacin, will be considered as potential candidates for study pending response to initial therapy and pending parental consent.
Key exclusion criteria (6 listed)
- Any baby not considered viable
- Any baby with intraventricular hemorrhage (IVH) grade 3-4 of recent onset (within 3 days). [If no head ultrasound has been performed within the last 3-4 days, one should be performed prior to onset of study.]
- Any baby with dysmorphic features or congenital abnormalities
- Any baby with structural heart disease other than PDA
- Any baby with documented infection,
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 |
|---|---|---|
| IndomethacinAlso: IndomedThree doses of intravenous (IV) indomethacin at 0.2 mg/kg/dose given over 30 minutes, at intervals of 12 hours | Drug | Indomethacin for resistant PDA |
| IbuprofenAlso: Arfen10 mg/kg infused over 30 minutes, followed by two doses of 5mg/kg each at 24 hour intervals | Drug | Ibuprofen for resistant PDA |
Primary outcome
Improvement in ductal closure rates in those infants who do not respond to a first course of therapy
Time frame: 2.5 years
2 secondary outcomes
More infants who did not respond to a first course of therapy with indomethacin who respond to a second course with ibuprofen than to a repeat course of indomethacin
Time frame: 2.5 years
Secondary treatment with ibuprofen, as opposed to indomethacin, will not be associated with increased side effects
Time frame: 2.5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2012.
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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.
Cathy Hammerman, MD principal investigator
Shaare Zedek Medical Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indomethacin and Ibuprofen in people with Patent Ductus Arteriosus, run by Shaare Zedek Medical Center at 1 site in Israel.
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 1 inclusion and 6 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: withdrawn, as of the sponsor's last update on 7 Jun 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 Israel. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improvement in ductal closure rates in those infants who do not respond to a first course of therapy (time frame: 2.5 years). 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 7 Jun 2012.