Cardiac Surgery for Babies Less Than 5 kg:Risk Factors for Morbidity and Mortality
Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05891405
Collaborator
(none)
100
17.1
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cardiac Surgery for Babies Less Than 5 kg:Risk Factors for Morbidity and Mortality
Anticipated Study Start Date
:
Jul 1, 2023
Anticipated Primary Completion Date
:
Jul 1, 2024
Anticipated Study Completion Date
:
Dec 1, 2024
Outcome Measures
Primary Outcome Measures
- Mortality [1 month postoperative]
Death after surgery
Secondary Outcome Measures
- Morbidity [1 month postoperative]
Complications after surgery
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Day
to 2 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
- neonates undergoing surgery for congenital heart diseases
Exclusion Criteria:
- larger body weights than 5 kg
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sohag University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ahmed Atef Ahmed,
Assistant lecturer,
Sohag University
ClinicalTrials.gov Identifier:
NCT05891405
Other Study ID Numbers:
- Soh-Med-23-05-02MD
First Posted:
Jun 6, 2023
Last Update Posted:
Jun 6, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No