Cardiac Surgery in NeonatesNCT05891405
Cardiac Surgery for Babies Less Than 5 kg:Risk Factors for Morbidity and Mortality
An observational study of Cardiac Surgery in Neonates, run by Sohag University.
Trial 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 Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Cardiac Surgery in Neonates
- What is being tested?
- Cardiac surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 2 years
- All sexes
- Child
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
Who may be able to join
- neonates undergoing surgery for congenital heart diseases
Who cannot join
- larger body weights than 5 kg
About this study
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
- Conditions
- Cardiac Surgery in Neonates
- Being tested
- Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac surgeryProcedure or surgery
Operations for congenital heart diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death after surgery
Measured: 1 month postoperative
Secondary outcomes (1)
Morbidity
Complications after surgery
Measured: 1 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study startJul 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery in NeonatesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Atef Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891405
- Sponsor's protocol ID
- Soh-Med-23-05-02MD
- Status last verified
- May 2023
- First submitted
- 28 May 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Surgery for Babies Less Than 5 kg:Risk Factors for Morbidity and Mortality
- ClinicalTrials.gov ID
- NCT05891405
- Acronym / sponsor ID
- Soh-Med-23-05-02MD
- Conditions
- Cardiac Surgery in Neonates
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jul 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 6 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- neonates undergoing surgery for congenital heart diseases
Key exclusion criteria (1 listed)
- larger body weights than 5 kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac surgeryOperations for congenital heart diseases | Procedure or surgery | – |
Primary outcome
Mortality
Time frame: 1 month postoperative
Death after surgery
1 secondary outcome
Morbidity
Time frame: 1 month postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery in Neonates, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 1 month postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.