Patent Ductus ArteriosusPhase 2NCT01291654
Paracetamol and Patent Ductus Arteriosus (PDA)
A Phase 2 study testing Paracetamol, NSAID and D5W in people with Patent Ductus Arteriosus, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial summary
The investigators propose that paracetamol will be similarly effective to ibuprofen in treating PDA in the premature neonate, with fewer side effects. Read more about this study
- Who is it for?
- Ages 2 days to 2 weeks
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- Paracetamol, NSAID and D5W
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2012to Dec 2014
- 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 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Echocardiographic diagnosis of hemodynamically significant patent ductus arteriosus
Who cannot join
- Major congenital anomalies
- Life-threatening infection
- Active NEC and/or intestinal perforation
- Recent (within the previous 24 hours) intraventricular hemorrhage Grade 3-4
- Urine output <1 ml per kilogram per hour during the preceding 8 hours
- Serum creatinine concentration of >1.6 mg %
- Platelet count of <60,000 per cc.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 91031
Cathy Hammerman, MD, +9722666-6238, cathy@cc.huji.ac.il
Cathy Hammerman, MD
About this study
Official title: Paracetamol in the Treatment of Patent Ductus Arteriosus in the Premature Neonate
The investigators propose that paracetamol will be similarly effective to ibuprofen in treating PDA in the premature neonate, with fewer side effects.
Read the detailed description
Preterm neonates with a hemodynamically significant PDA will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1.po Paracetamol at a dose of 15 mg/kg every 6 hours at x 3 days or Group 2- IV indomethacin - 0.2 mg/kg/dose q 12h for three doses; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).Clinical staff will be blinded as to the study group assignment of the babies and since the group 1 drug is to be given every six hours, all babies will receive a parenteral substance every 6 hours. For Group 2 infants, the intermittent doses will be IV D5W alternating with drug.All infants will fed trophic feeds (20 cc/kg/day) during the treatment for ductal closure.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- Paracetamol, NSAID, D5W
- Keywords
- PDA, Paracetamol, 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.
ParacetamolDrug
po Paracetamol 15 mg/kg every 6 hours x 3 days
NSAIDDrug
IV indomethacin 2 mg/kg/dose for three doses at 12 hour intervals; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).
D5WDrug
Since the paracetamol is given q 6 hours, in order to maintain blinding of the clinical staff, a placebo (D5W) must be given intermittently between the doses of NSAID such that each infant will receive drug every 6 hours.
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol | Experimental | Babies with hsPDA will be treated with paracetamol 15 mg/kg/dose x 4/day for three days Receives: Drug: Paracetamol |
| NSAID | Experimental | Babies with hsPDA will be randomized to treatment with IV indomethacin 17 mcg/kg/hr x 36 hr Receives: Drug: NSAID; Drug: D5W |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure of the Ductus
Measured: 3 days
Secondary outcomes (2)
Absence of peripheral vasoconstriction
Doppler flow velocity in anterior cerebral artery, superior mesenteric artery and renal artery will be measured before and after pharmacologic treatment.
Measured: 48 hours
Absence of hepatotoxicity
Liver function will be compared between the two study groups at 1 week following completion of pharmacologic treatment
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2011 (estimated)
- Study startApr 2012
- Primary completionDec 2014 (estimated)
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathy Hammerman, Shaare Zedek Medical Center
- Investigators
- Cathy Hammerman, MD, Principal investigator, Hebrew University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01291654
- Sponsor's protocol ID
- SZMC-Hammerman-Acamol-2011
- Status last verified
- Dec 2012
- First submitted
- 6 Feb 2011
- Last updated
- 19 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paracetamol in the Treatment of Patent Ductus Arteriosus in the Premature Neonate
- ClinicalTrials.gov ID
- NCT01291654
- Acronym / sponsor ID
- SZMC-Hammerman-Acamol-2011
- Conditions
- Patent Ductus Arteriosus
- Keywords
- PDA, Paracetamol, Indomethacin, Ibuprofen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Dec 2014 (estimated)
- First posted
- 8 Feb 2011 (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 investigators propose that paracetamol will be similarly effective to ibuprofen in treating PDA in the premature neonate, with fewer side effects.
Detailed description
Preterm neonates with a hemodynamically significant PDA will potentially be candidates for study. After obtaining parental consent, the infants will be prospectively and randomly assigned to one of two groups: 1.po Paracetamol at a dose of 15 mg/kg every 6 hours at x 3 days or Group 2- IV indomethacin - 0.2 mg/kg/dose q 12h for three doses; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).Clinical staff will be blinded as to the study group assignment of the babies and since the group 1 drug is to be given every six hours, all babies will receive a parenteral substance every 6 hours. For Group 2 infants, the intermittent doses will be IV D5W alternating with drug.All infants will fed trophic feeds (20 cc/kg/day) during the treatment for ductal closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol | Experimental | Drug: ParacetamolBabies with hsPDA will be treated with paracetamol 15 mg/kg/dose x 4/day for three days |
| NSAID | Experimental | Drug: NSAID, Drug: D5WBabies with hsPDA will be randomized to treatment with IV indomethacin 17 mcg/kg/hr x 36 hr |
Who may qualify
- Ages
- 2 days to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Echocardiographic diagnosis of hemodynamically significant patent ductus arteriosus
Key exclusion criteria (7 listed)
- Major congenital anomalies
- Life-threatening infection
- Active NEC and/or intestinal perforation
- Recent (within the previous 24 hours) intraventricular hemorrhage Grade 3-4
- Urine output <1 ml per kilogram per hour during the preceding 8 hours
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 |
|---|---|---|
| Paracetamolpo Paracetamol 15 mg/kg every 6 hours x 3 days | Drug | Paracetamol |
| NSAIDIV indomethacin 2 mg/kg/dose for three doses at 12 hour intervals; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses). | Drug | NSAID |
| D5WSince the paracetamol is given q 6 hours, in order to maintain blinding of the clinical staff, a placebo (D5W) must be given intermittently between the doses of NSAID such that each infant will receive drug every 6 hours. | Drug | NSAID |
Primary outcome
Closure of the Ductus
Time frame: 3 days
2 secondary outcomes
Absence of peripheral vasoconstriction
Time frame: 48 hours
Absence of hepatotoxicity
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 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
Hebrew University Faculty of Medicine
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 Paracetamol, NSAID and D5W 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 7 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: status not confirmed, as of the sponsor's last update on 19 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cathy Hammerman, MD (+9722666-6238, cathy@cc.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Closure of the Ductus (time frame: 3 days). 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 19 Dec 2012.