Patent Ductus ArteriosusPhase 2NCT04026464
Addition of Acetaminophen in Standard PDA Management
A Phase 2 study testing Intravenous Ibuprofen and Intravenous Ibuprofen + Oral Acetaminophen in people with Patent Ductus Arteriosus, run by University of Florida.
Trial summary
Patent ductus arteriosus is a common morbidity in preterm infants and management of PDA varies among neonatologist. The investigators are conducting a randomized controlled trial to determine the rates of initial patent ductus arteriosus (PDA) closure after completion of a first treatment course. Read more about this study
- Who is it for?
- Ages 23 to 28 weeks
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- Intravenous Ibuprofen and Intravenous Ibuprofen + Oral Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to 12 May 2021
- 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 23 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants 23 0/7 to 27 6/7 weeks' gestational age and birth weight < 1000 grams
- Hemodynamically significant PDA as defined by any of the following:
- Increased ventilator or oxygen support attributed by the clinician to be due to increased left-right shunting through the PDA
- Hypotension and/or widening pulse pressure requiring continuous dopamine infusion (hypotension is defined as mean arterial pressure (MAP) at least 2-3 mmHg below the infants' post menstrual age)
- Signs of congestive heart failure (e.g increased pulmonary congestion on chest radiograph or hepatomegaly on physical examination)
- Echocardiographic criteria:
- Ratio of the smallest ductal diameter to the ostium of the left pulmonary artery > 0.5
Who cannot join
- No enteral feedings
- PDA-dependent congenital heart disease
- Prior treatment with prophylactic indomethacin
- Prior PDA treatment with any medications
- Suspected or diagnosed acute necrotizing enterocolitis (NEC) or spontaneous intestinal perforation
- Abnormal liver enzymes (ALT > 60 IU/L and AST > 60 IU/L)
Show all 9Show fewer
- Platelets count < 50,000 /μl; and / or active intracranial, gastrointestinal, or other bleeding
- Major congenital anomalies such as neural tube defect, known or suspected chromosomal abnormality, and gastrointestinal defect
- Prior enrollment to other interventional clinical study where PDA is an outcome variable
About this study
Official title: Monotherapy (Ibuprofen) vs. Combination Therapy (Ibuprofen and Acetaminophen) in the Management of Patent Ductus Arteriosus in Premature Infants: A Randomized Controlled Trial
Patent ductus arteriosus is a common morbidity in preterm infants and management of PDA varies among neonatologist. The investigators are conducting a randomized controlled trial to determine the rates of initial patent ductus arteriosus (PDA) closure after completion of a first treatment course.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- Intravenous Ibuprofen, Intravenous Ibuprofen + Oral 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.
Intravenous IbuprofenDrug
The control monotherapy group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently.
Intravenous Ibuprofen + Oral AcetaminophenDrug
The combined treatment group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently and will in addition receive 15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen+Acetaminophen Group | Active comparator | Infants with PDA randomized to the combined treatment group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) and oral acetaminophen (15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses). Receives: Drug: Intravenous Ibuprofen + Oral Acetaminophen |
| Ibuprofen Group | Placebo comparator | Infants with PDA randomized to the control mono therapy group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) alone. Receives: Drug: Intravenous Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of infants with PDA closure.
Percentage of patients who demonstrated PDA closure.
Measured: During hospitalization, up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2019
- Study startApr 2021 (estimated)
- Primary completion12 May 2021
- Study completion12 May 2021
Why it stopped: Unable to obtain funding to support this project
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.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanket D Shah, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04026464
- Sponsor's protocol ID
- IRB201901829 -A
- Status last verified
- Jun 2021
- First submitted
- 16 Jul 2019
- Last updated
- 24 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monotherapy (Ibuprofen) vs. Combination Therapy (Ibuprofen and Acetaminophen) in the Management of Patent Ductus Arteriosus in Premature Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04026464
- Acronym / sponsor ID
- IRB201901829 -A
- Conditions
- Patent Ductus Arteriosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to obtain funding to support this project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 12 May 2021 (actual)
- First posted
- 19 Jul 2019 (actual)
- 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.
Patent ductus arteriosus is a common morbidity in preterm infants and management of PDA varies among neonatologist. The investigators are conducting a randomized controlled trial to determine the rates of initial patent ductus arteriosus (PDA) closure after completion of a first treatment course.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen+Acetaminophen Group | Active comparator | Drug: Intravenous Ibuprofen + Oral AcetaminophenInfants with PDA randomized to the combined treatment group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) and oral acetaminophen (15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses). |
| Ibuprofen Group | Placebo comparator | Drug: Intravenous IbuprofenInfants with PDA randomized to the control mono therapy group receiving intravenous ibuprofen (10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently) alone. |
Who may qualify
- Ages
- 23 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infants 23 0/7 to 27 6/7 weeks' gestational age and birth weight < 1000 grams
- Hemodynamically significant PDA as defined by any of the following:
- Echocardiographic criteria:
Key exclusion criteria (9 listed)
- No enteral feedings
- PDA-dependent congenital heart disease
- Prior treatment with prophylactic indomethacin
- Prior PDA treatment with any medications
- Suspected or diagnosed acute necrotizing enterocolitis (NEC) or spontaneous intestinal perforation
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 |
|---|---|---|
| Intravenous IbuprofenThe control monotherapy group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently. | Drug | Ibuprofen Group |
| Intravenous Ibuprofen + Oral AcetaminophenThe combined treatment group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently and will in addition receive 15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses. | Drug | Ibuprofen+Acetaminophen Group |
Primary outcome
Percentage of infants with PDA closure.
Time frame: During hospitalization, up to 10 days
Percentage of patients who demonstrated PDA closure.
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 24 Jun 2021.
- 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.
Sanket D Shah, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intravenous Ibuprofen and Intravenous Ibuprofen + Oral Acetaminophen in people with Patent Ductus Arteriosus, run by University of Florida.
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 7 inclusion and 9 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 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Percentage of infants with PDA closure. (time frame: During hospitalization, up to 10 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 24 Jun 2021.