Patent Ductus ArteriosusNCT03026192
Near Infrared Spectroscopy to Determine Patent Ductus Arteriosus Closure
An observational study of Patent Ductus Arteriosus, run by Albany Medical College at 1 site in United States.
Trial summary
Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in preterm infants after completing medical treatment for a hemodynamically significant PDA. Read more about this study
- Who is it for?
- Ages 1 minute to 1 weekHealthy volunteers can take part
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- near infrared spectroscopy
- Type of treatment
- Medical device
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 30 Jun 2018
- Phase
- Observational
- 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 1 week
- All sexes
- Healthy volunteers accepted
- Child
Study population: Preterm infants both with and without hsPDA. They will have NIRS monitors placed to measure cerebral and renal regional tissue oxygenation. Those without a hsPDA will be monitored solely around the time of initial echocardiogram. Those with a hsPDA will be monitored around initial echocardiogram and the subsequent echocardiogram after treatment completion.
Who may be able to join
- preterm infants less than 32 weeks gestation
Who cannot join
- infection, congenital heart disease, syndromic anomalies, and perinatal asphyxia.
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: Use of Near Infrared Spectroscopy in Preterm Infants to Determine Patent Ductus Arteriosus Closure Following Medical Treatment
Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in preterm infants after completing medical treatment for a hemodynamically significant PDA.
- Conditions
- Patent Ductus Arteriosus
- Being tested
- near infrared spectroscopy
- 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.
near infrared spectroscopyDevice
Near infrared spectroscopy will be placed on infants both with and without hsPDA
| Study group | Role | What they receive |
|---|---|---|
| no PDA | These are infants who do not have a patent ductus arteriosus (PDA) as determine by echocardiography Receives: Device: near infrared spectroscopy | |
| hsPDA | These are infants who have a hemodynamically significant PDA (hsPDA) as determined by echocardiography Receives: Device: near infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NIRS readings
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 posted20 Jan 2017 (estimated)
- Study startDec 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Why it stopped: not enough patients enrolled in study
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 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
- NCT03026192
- Sponsor's protocol ID
- 4585
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2017
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Near Infrared Spectroscopy in Preterm Infants to Determine Patent Ductus Arteriosus Closure Following Medical Treatment
- ClinicalTrials.gov ID
- NCT03026192
- Acronym / sponsor ID
- 4585
- Conditions
- Patent Ductus Arteriosus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: not enough patients enrolled in study
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Albany Medical CollegeUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 20 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.
Using cerebral and renal near infrared spectroscopy monitoring to determine PDA closure in preterm infants after completing medical treatment for a hemodynamically significant PDA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no PDA | – | Device: near infrared spectroscopyThese are infants who do not have a patent ductus arteriosus (PDA) as determine by echocardiography |
| hsPDA | – | Device: near infrared spectroscopyThese are infants who have a hemodynamically significant PDA (hsPDA) as determined by echocardiography |
Who may qualify
- Ages
- 1 minute to 1 week
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Preterm infants both with and without hsPDA. They will have NIRS monitors placed to measure cerebral and renal regional tissue oxygenation. Those without a hsPDA will be monitored solely around the time of initial echocardiogram. Those with a hsPDA will be monitored around initial echocardiogram and the subsequent echocardiogram after treatment completion.
Key inclusion criteria (1 listed)
- preterm infants less than 32 weeks gestation
Key exclusion criteria (1 listed)
- infection, congenital heart disease, syndromic anomalies, and perinatal asphyxia.
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 |
|---|---|---|
| near infrared spectroscopyNear infrared spectroscopy will be placed on infants both with and without hsPDA | Device | hsPDA, no PDA |
Primary outcome
Change in NIRS readings
Time frame: 3 days
Results and safety
The study was stopped early (reason given: not enough patients enrolled in study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 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?
An observational study of 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 1 inclusion and 1 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 23 Jan 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 was stopped early (reason given: not enough patients enrolled in study). 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?
Change in NIRS readings (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 23 Jan 2019.