Patent Ductus ArteriosusNCT04415554
Aminoglycosides and Duct
An observational study of Patent Ductus Arteriosus, run by Carmel Medical Center.
Trial summary
The aim of the study is to assess the effect of aminoglycoside treatment on ductal closure in preterms Read more about this study
- Who is it for?
- Ages 30 minutes to 3 weeksHealthy volunteers can take part
- Conditions the study is for
- Patent Ductus Arteriosus
- What is being tested?
- echocardiography
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jul 2021to Dec 2022
- 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 30 minutes to 3 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: preterm infants hospitalized in NICU
Who may be able to join
- infants born at or above 32 weeks of gestation
- -
Who cannot join
- infants who are unlikely to survive or have congenital heart defects
About this study
Official title: The Effect of Aminoglycosides on Ductus in Preterm Infants
The aim of the study is to assess the effect of aminoglycoside treatment on ductal closure in preterms
- Conditions
- Patent Ductus Arteriosus
- Being tested
- echocardiography
- 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.
echocardiographyDiagnostic test
echocardiography exam of the infant
| Study group | Role | What they receive |
|---|---|---|
| exposure to aminoglicosides | preterm receiving aminoglycosides Receives: Diagnostic Test: echocardiography | |
| non exposure to aminoglycosides | preterm not receiving aminoglycosides Receives: Diagnostic Test: echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
ductal closure
closure of ductus arteriosus
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study startJul 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayala Gover, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04415554
- Sponsor's protocol ID
- CMC-19-0110-CTIL
- Status last verified
- Feb 2021
- First submitted
- 1 Jun 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aminoglycosides on Ductus in Preterm Infants
- ClinicalTrials.gov ID
- NCT04415554
- Acronym / sponsor ID
- CMC-19-0110-CTIL
- Conditions
- Patent Ductus Arteriosus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 4 Jun 2020 (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.
The aim of the study is to assess the effect of aminoglycoside treatment on ductal closure in preterms
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exposure to aminoglicosides | – | Diagnostic Test: echocardiographypreterm receiving aminoglycosides |
| non exposure to aminoglycosides | – | Diagnostic Test: echocardiographypreterm not receiving aminoglycosides |
Who may qualify
- Ages
- 30 minutes to 3 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- preterm infants hospitalized in NICU
Key inclusion criteria (2 listed)
- infants born at or above 32 weeks of gestation
- -
Key exclusion criteria (1 listed)
- infants who are unlikely to survive or have congenital heart defects
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 |
|---|---|---|
| echocardiographyechocardiography exam of the infant | Diagnostic test | exposure to aminoglicosides, non exposure to aminoglycosides |
Primary outcome
ductal closure
Time frame: 3 weeks
closure of ductus arteriosus
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Patent Ductus Arteriosus, run by Carmel Medical Center.
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 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: status not confirmed, as of the sponsor's last update on 9 Feb 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. 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?
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?
ductal closure (time frame: 3 weeks). 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 9 Feb 2021.