Patent Ductus ArteriosusNCT03008876
IV Acetaminophen and Patent Ductus Arteriosus
A study testing Acetaminophen and Ibuprofen in people with Patent Ductus Arteriosus, run by Albany Medical College at 1 site in United States.
Trial summary
This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm infants. Read more about this study
- Who is it for?
- Ages 1 minute to 2 weeksHealthy volunteers can take part
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- Acetaminophen and Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2017to 30 Jun 2019
- 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 minute to 2 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- preterm infants 23-30 weeks gestation,
- PDA requiring treatment
Who cannot join
- infection,
- congenital heart disease,
- genetic syndrome,
- NEC,
- pulmonary hypertension,
- hydrops,
Show all 10Show fewer
- intestinal perforation,
- grade 3 or 4 IVH,
- serum creatinine >1.5,
- previous treatment with a COX inhibitor.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albany Medical Center Neonatal Intesive Care Unit
Albany, New York, 12208
About this study
Official title: The Efficacy of IV Acetaminophen on Patent Ductus Arteriosus Closure in Preterm Infants
This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm infants.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- Acetaminophen, Ibuprofen
- Keywords
- neonate, acetaminophen
- 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.
AcetaminophenDrug
Also called tylenol
infants receive acetaminophen for treatment of their PDA
IbuprofenDrug
infants receive ibuprofen, standard of care in our unit, for treatment of a PDA
| Study group | Role | What they receive |
|---|---|---|
| acetaminophen | Experimental | Group of patients randomized to receive acetaminophen to treat their PDA Receives: Drug: Acetaminophen |
| ibuprofen | Active comparator | Group of patients randomized to receive ibuprofen to treat their PDA Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of PDA Closure
PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.
Measured: 3 days
Secondary outcomes (1)
Change in PDA size
Size of PDA will be measured by echocardiography to determine if the size has changed after treatment is complete
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start1 Jan 2017
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albany Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kate Tauber, Albany Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03008876
- Sponsor's protocol ID
- 4683
- Status last verified
- Jul 2019
- First submitted
- 30 Dec 2016
- Last updated
- 8 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of IV Acetaminophen on Patent Ductus Arteriosus Closure in Preterm Infants
- ClinicalTrials.gov ID
- NCT03008876
- Acronym / sponsor ID
- 4683
- Conditions
- Patent Ductus Arteriosus
- Keywords
- neonate, acetaminophen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 4 Jan 2017 (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.
This is a randomized controlled trial to evaluate the efficacy of IV acetaminophen versus IV ibuprofen in closing a hemodynamically significant patent ductus arteriosus in preterm infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acetaminophen | Experimental | Drug: AcetaminophenGroup of patients randomized to receive acetaminophen to treat their PDA |
| ibuprofen | Active comparator | Drug: IbuprofenGroup of patients randomized to receive ibuprofen to treat their PDA |
Who may qualify
- Ages
- 1 minute to 2 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- preterm infants 23-30 weeks gestation,
- PDA requiring treatment
Key exclusion criteria (10 listed)
- infection,
- congenital heart disease,
- genetic syndrome,
- NEC,
- pulmonary hypertension,
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 |
|---|---|---|
| AcetaminophenAlso: tylenolinfants receive acetaminophen for treatment of their PDA | Drug | acetaminophen |
| Ibuprofeninfants receive ibuprofen, standard of care in our unit, for treatment of a PDA | Drug | ibuprofen |
Primary outcome
Rate of PDA Closure
Time frame: 3 days
PDA will be evaluated by echocardiography to determined whether it has closed after treatment is complete.
1 secondary outcome
Change in PDA size
Time frame: 3 days
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 8 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen and Ibuprofen in people with Patent Ductus Arteriosus, run by Albany Medical College at 1 site in United States.
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 10 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 8 Jul 2019. 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 United States. 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?
Rate of PDA Closure (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 8 Jul 2019.