NCT04672629

Brief Summary

The study aims to evaluate the clinical presentation and course of PDA diagnosed at neonatal period in the neonatology unit of Assiut University Hospital for Children.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

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

December 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

March 5, 2021

Status Verified

December 1, 2020

Enrollment Period

9 months

First QC Date

December 11, 2020

Last Update Submit

March 3, 2021

Conditions

Patent Ductus Arteriosus

Outcome Measures

Primary Outcomes (1)

  • Determine the percentage of cases with PDA admitted to our neonatology unit per year.

    This study was proposed to improve practice in our neonatal unit regarding interpretation of echocardiograms showing the diagnosis of PDA and decisions based on.

    one year

Interventions

echocardiographyDEVICE

follow up echocardiography

Eligibility Criteria

Age0 Days - 28 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

1- Neonatal period (0-28 days) including fullterm and preterm infants for whom echocardiography is indicated

You may qualify if:

  • \- 1- Neonatal period (0-28 days) including fullterm and preterm infants for whom echocardiography is indicated.
  • Absence of other congenital cardiac defects.

You may not qualify if:

  • PDA associated with other cardiac anomalies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Vettukattil JJ. Pathophysiology of Patent Ductus Arteriosus in the Preterm Infant. Curr Pediatr Rev. 2016;12(2):120-2. doi: 10.2174/157339631202160506002215.

    PMID: 27197953BACKGROUND

  • Louis D, ElSayed YN, Ojah C, Alvaro R, Shah PS, Dunn M; Canadian Neonatal Network Investigators. Predictors of PDA Treatment in Preterm Neonates Who Had Received Prophylactic Indomethacin. Am J Perinatol. 2018 Apr;35(5):509-514. doi: 10.1055/s-0037-1608792. Epub 2017 Nov 28.

    PMID: 29183097BACKGROUND

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

Central Study Contacts

Martina Emad Amin, doctor

CONTACT

01016940909Martinaemad1411@gmail.com

Salah - Eldin Amry Ahmad, professor

CONTACT

01550855453S_amry@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 17, 2020

Study Start

April 1, 2021

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

March 5, 2021

Record last verified: 2020-12