NCT04415554

Brief Summary

The aim of the study is to assess the effect of aminoglycoside treatment on ductal closure in preterms

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

1 year

First QC Date

June 1, 2020

Last Update Submit

February 7, 2021

Conditions

Patent Ductus Arteriosus

Outcome Measures

Primary Outcomes (1)

  • ductal closure

    closure of ductus arteriosus

    3 weeks

Study Arms (2)

exposure to aminoglicosides

preterm receiving aminoglycosides

Diagnostic Test: echocardiography

non exposure to aminoglycosides

preterm not receiving aminoglycosides

Diagnostic Test: echocardiography

Interventions

echocardiographyDIAGNOSTIC_TEST

echocardiography exam of the infant

exposure to aminoglicosidesnon exposure to aminoglycosides

Eligibility Criteria

Age30 Minutes - 3 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

preterm infants hospitalized in NICU

You may qualify if:

  • infants born at or above 32 weeks of gestation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ductus Arteriosus, Patent

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neonatologist

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 4, 2020

Study Start

July 1, 2021

Primary Completion

July 1, 2022

Study Completion

December 1, 2022

Last Updated

February 9, 2021

Record last verified: 2021-02