Patent Ductus ArteriosusPhase 4OIDSNCT00961753
Safety/Efficacy Study of Optimizing Ibuprofen Dosing to Achieve Higher PDA Closure Rates
A Phase 4 study testing optimized ibuprofen and Standard Ibuprofen in people with Patent Ductus Arteriosus, run by OSF Healthcare System at 1 site in United States.
Trial summary
The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies. Read more about this study
- Who is it for?
- Ages 1 day to 29 days
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- optimized ibuprofen and Standard Ibuprofen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Oct 2010
- Phase
- Phase 4
- 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 29 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All neonates (0-29 days old) less than or equal to 33 post-menstrual age at time of PDA diagnosis requiring nasal CPAP or mechanical ventilation
- Echo confirmed PDA with a transductal diameter of 1.5 mm or greater and demonstrating a left-to-right shunt
- Signed informed consent
Who cannot join
- Presence of: ductal-dependent congenital heart disease, pulmonary hypertension,
- Active bleeding (including Grade 3 or 4 IVH)
- Platelet count < 100,000
- Coagulopathy
- Suspected NEC
- Suspected perforation
Show all 10Show fewer
- Creatinine > 1.5
- Hyperbilirubinemia requiring exchange transfusion
- Hypotension requiring pressor support
- Life-threatening congenital malformation
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Illinois at OSF Saint Francis Medical Center
Peoria, Illinois, 61637
About this study
Official title: Safety and Efficacy of an Optimized Ibuprofen Dosing Regimen Versus Standard Dosing for Pharmacologic Closure of Patent Ductus Arteriosus
The purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.
Read the detailed description
Failure to close the PDA in premature neonates in a timely fashion can lead to pulmonary over-circulation and systemic under-circulation. The PDA often fails to close using currently approved Ibuprofen dosing regimens, and surgical closure becomes necessary. Ibuprofen clearance in premature neonates is significantly correlated with postnatal age, increasing rapidly over time. Hirt et al. published and optimized dosing scheme for preterm neonates based on pharmacokinetic and pharmacodynamic data. We aim to use this dosing regimen in the clinical setting to determine if increased rates of pharmacologic PDA closure can be achieved.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- optimized ibuprofen, Standard Ibuprofen
- Keywords
- PDA, Ibuprofen, Preterm, Neonate
- Medical subject headings
- Ductus Arteriosus, Patent, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
optimized ibuprofenDrug
Also called neoprofen
day of life 0-3 - 10, 5, 5 mg/kg/dose at 24 hour intervals day of life 4-6 - 14, 7, 7 mg/kg/dose at 24 hour intervals day of life 7-29 - 20, 10, 10 mg/kg/dose at 24 hour intervals
Standard IbuprofenDrug
Also called neoprofen
day of life 0-29 - 10,5, 5 mg/kg/dose at 24 hour intervals
| Study group | Role | What they receive |
|---|---|---|
| Optimized Ibuprofen | Experimental | Not described Receives: Drug: optimized ibuprofen |
| Standard Ibuprofen | Active comparator | Not described Receives: Drug: Standard Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
PDA Closure
Measured: 1-42 days of age
Secondary outcomes (1)
renal function
Measured: 1-30 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: FDA drug recall on July 30, 2010
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- OSF Healthcare System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Hocker, OSF Healthcare System
- Investigators
- James R Hocker, MD, Principal investigator, OSF Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961753
- Sponsor's protocol ID
- Ibuprofendosingstudy
- Acronym
- OIDS
- Status last verified
- Jan 2014
- First submitted
- 18 Aug 2009
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of an Optimized Ibuprofen Dosing Regimen Versus Standard Dosing for Pharmacologic Closure of Patent Ductus Arteriosus
- ClinicalTrials.gov ID
- NCT00961753
- Acronym / sponsor ID
- OIDS / Ibuprofendosingstudy
- Conditions
- Patent Ductus Arteriosus
- Keywords
- PDA, Ibuprofen, Preterm, Neonate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA drug recall on July 30, 2010
- Enrolment
- 10 participants (actual)
- Lead sponsor
- OSF Healthcare SystemUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 19 Aug 2009 (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 purpose of this study is to determine if increasing the ibuprofen dose will increase the likelihood of closing the patent ductus arteriosus in premature babies.
Detailed description
Failure to close the PDA in premature neonates in a timely fashion can lead to pulmonary over-circulation and systemic under-circulation. The PDA often fails to close using currently approved Ibuprofen dosing regimens, and surgical closure becomes necessary. Ibuprofen clearance in premature neonates is significantly correlated with postnatal age, increasing rapidly over time. Hirt et al. published and optimized dosing scheme for preterm neonates based on pharmacokinetic and pharmacodynamic data. We aim to use this dosing regimen in the clinical setting to determine if increased rates of pharmacologic PDA closure can be achieved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimized Ibuprofen | Experimental | Drug: optimized ibuprofen |
| Standard Ibuprofen | Active comparator | Drug: Standard Ibuprofen |
Who may qualify
- Ages
- 1 day to 29 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- All neonates (0-29 days old) less than or equal to 33 post-menstrual age at time of PDA diagnosis requiring nasal CPAP or mechanical ventilation
- Echo confirmed PDA with a transductal diameter of 1.5 mm or greater and demonstrating a left-to-right shunt
- Signed informed consent
Key exclusion criteria (10 listed)
- Presence of: ductal-dependent congenital heart disease, pulmonary hypertension,
- Active bleeding (including Grade 3 or 4 IVH)
- Platelet count < 100,000
- Coagulopathy
- Suspected NEC
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 |
|---|---|---|
| optimized ibuprofenAlso: neoprofenday of life 0-3 - 10, 5, 5 mg/kg/dose at 24 hour intervals day of life 4-6 - 14, 7, 7 mg/kg/dose at 24 hour intervals day of life 7-29 - 20, 10, 10 mg/kg/dose at 24 hour intervals | Drug | Optimized Ibuprofen |
| Standard IbuprofenAlso: neoprofenday of life 0-29 - 10,5, 5 mg/kg/dose at 24 hour intervals | Drug | Standard Ibuprofen |
Primary outcome
PDA Closure
Time frame: 1-42 days of age
1 secondary outcome
renal function
Time frame: 1-30 days of age
Results and safety
The study was stopped early (reason given: FDA drug recall on July 30, 2010). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
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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.
James R Hocker, MD principal investigator
OSF Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing optimized ibuprofen and Standard Ibuprofen in people with Patent Ductus Arteriosus, run by OSF Healthcare System 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 3 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: stopped early, as of the sponsor's last update on 28 Jan 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 stopped early (reason given: FDA drug recall on July 30, 2010). Results are not available in the source record.
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?
PDA Closure (time frame: 1-42 days of age). 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 28 Jan 2014.