Aminoglycosides and Duct

February 7, 2021 updated by: Ayala Gover, Carmel Medical Center

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 minutes to 3 weeks (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

preterm infants hospitalized in NICU

Description

Inclusion Criteria:

infants born at or above 32 weeks of gestation

-

Exclusion Criteria:

  • infants who are unlikely to survive or have congenital heart defects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
exposure to aminoglicosides
preterm receiving aminoglycosides
Diagnostic test: echocardiography
echocardiography exam of the infant
non exposure to aminoglycosides
preterm not receiving aminoglycosides
Diagnostic test: echocardiography
echocardiography exam of the infant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ductal closure
Time Frame: 3 weeks
closure of ductus arteriosus
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carmel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

July 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 7, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMC-19-0110-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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