Indomethacin TherapyNCT00500305
The Use of B-type Natriuretic Peptide (BNP) to Predict Closure of a Patent Ductus Arteriosus (PDA) in Premature Infants
A study testing Withhold standard INDO dose if BNP < 100 pg/ml in people with Indomethacin Therapy and Patent Ductus Arteriosus, run by University of Virginia.
Trial summary
A patent ductus arteriosus (PDA) is associated with increased morbidity in premature infants. Standard indomethacin treatment is associated with intestinal and renal morbidity. B-type natriuretic peptide is elevated in significant PDAs. Read more about this study
- Who is it for?
- Ages Up to 4 months
- Conditions the study is for
- Indomethacin Therapy, Patent Ductus Arteriosus
- What is being tested?
- Withhold standard INDO dose if BNP < 100 pg/ml
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to Mar 2007
- 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 Up to 4 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with echocardiographically confirmed PDA
- Infants determined by attending physician to require PDA closure
Who cannot join
- infants with congenital hearts disease
- infants with creatinine value > 2.0
About this study
A patent ductus arteriosus (PDA) is associated with increased morbidity in premature infants. Standard indomethacin treatment is associated with intestinal and renal morbidity. B-type natriuretic peptide is elevated in significant PDAs. This study will determine whether BNP guided therapy could reduce doses of indomethacin.
- Conditions
- Indomethacin Therapy, Patent Ductus Arteriosus
- Being tested
- Withhold standard INDO dose if BNP < 100 pg/ml
- Keywords
- indomethacin therapy, patent ductus arteriosus
- 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.
Withhold standard INDO dose if BNP < 100 pg/mlProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of indomethacin doses given on study
Measured: 2 days
Secondary outcomes (2)
rate of PDA ligation
Measured: Discharge from NICU
Rate of Chronic lung disease
Measured: 36 weeks corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2007 (estimated)
- Study startApr 2004
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Indomethacin TherapyStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Investigators
- D Sc Lim, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500305
- Sponsor's protocol ID
- 10946
- Status last verified
- May 2018
- First submitted
- 10 Jul 2007
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of B-type Natriuretic Peptide (BNP) to Predict Closure of a Patent Ductus Arteriosus (PDA) in Premature Infants
- ClinicalTrials.gov ID
- NCT00500305
- Acronym / sponsor ID
- 10946
- Conditions
- Indomethacin Therapy, Patent Ductus Arteriosus
- Keywords
- indomethacin therapy, patent ductus arteriosus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Apr 2004
- Study completion
- Mar 2007 (actual)
- First posted
- 12 Jul 2007 (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.
A patent ductus arteriosus (PDA) is associated with increased morbidity in premature infants. Standard indomethacin treatment is associated with intestinal and renal morbidity. B-type natriuretic peptide is elevated in significant PDAs. This study will determine whether BNP guided therapy could reduce doses of indomethacin.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants with echocardiographically confirmed PDA
- Infants determined by attending physician to require PDA closure
Key exclusion criteria (2 listed)
- infants with congenital hearts disease
- infants with creatinine value > 2.0
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 |
|---|---|---|
| Withhold standard INDO dose if BNP < 100 pg/ml | Procedure or surgery | – |
Primary outcome
Number of indomethacin doses given on study
Time frame: 2 days
2 secondary outcomes
rate of PDA ligation
Time frame: Discharge from NICU
Rate of Chronic lung disease
Time frame: 36 weeks corrected gestational age
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 7 May 2018.
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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.
D Sc Lim, MD principal investigator
University of Virginia
Questions about this trial
What is this clinical trial studying?
A study testing Withhold standard INDO dose if BNP < 100 pg/ml in people with Indomethacin Therapy and Patent Ductus Arteriosus, run by University of Virginia.
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 2 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 7 May 2018. 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. 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?
Number of indomethacin doses given on study (time frame: 2 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 7 May 2018.