NCT03850223

Brief Summary

Congenital Heart Disease (CHD) is the most common birth defect in the United States, affecting approximately 0.8% of live births. Improved treatment strategies and interventions have increased survival such that 85% to 90% of affected children are expected to live well into adulthood, thereby causing a demographic shift in which adults now outnumber children with CHD, and more people with complex CHD are living longer.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

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

February 20, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
1 year until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 24, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

February 20, 2019

Last Update Submit

February 21, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Clinical audit study to assess management of congenital heart disease in AUCH

    To assess how much the adopted protocol of management of congenital heart disease is implemented in Assiut university children hospital

    One year

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children with congenital heart disease more than one month and less than 18 years

You may qualify if:

  • children with CHD more than one month

You may not qualify if:

  • children with CHD less than one month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Mostafa Shafeek Khalaf, Professor

CONTACT

Khaled Abdelaziz Sanusy, Assistant Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 21, 2019

Study Start

March 1, 2020

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

February 24, 2020

Record last verified: 2020-02