Cardiac Surgery for Babies Less Than 5 kg:Risk Factors for Morbidity and Mortality
May 28, 2023 updated by: Ahmed Atef Ahmed, Sohag University
Cardiac surgery in babies less than 6 kg of weight is a complex and high-risk procedure.
Despite advances in medical technology, mortality and morbidity rates remain high.
This study seeks to identify risk factors associated with mortality and morbidity in this population
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
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
- Child
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Neonates with congenital heart diseases undergoing surgery for complete or partial treatment with body weight less than 5 kg at time of surgery
Description
Inclusion Criteria:
- neonates undergoing surgery for congenital heart diseases
Exclusion Criteria:
- larger body weights than 5 kg
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mortality
Time Frame: 1 month postoperative
|
Death after surgery
|
1 month postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morbidity
Time Frame: 1 month postoperative
|
Complications after surgery
|
1 month postoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
July 1, 2023
Primary Completion (Estimated)
July 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
May 28, 2023
First Submitted That Met QC Criteria
May 28, 2023
First Posted (Actual)
June 6, 2023
Study Record Updates
Last Update Posted (Actual)
June 6, 2023
Last Update Submitted That Met QC Criteria
May 28, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Soh-Med-23-05-02MD
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.