Congenital Heart DiseaseNCT06031831
Analysis of Risk Factors and Prognosis of Pediatric Patients After Operations for Congenital Heart Disease
An observational study of Congenital Heart Disease and Pediatric, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This hospital-based retrospective study reviewed patients who underwent surgery for CHD between 2017 and 2020 and analyzed the clinical features and outcomes associated with airway anomalies. Read more about this study
- Who is it for?
- Ages 0 days to 18 years
- Conditions the study is for
- Congenital Heart Disease, Pediatric
- What is being tested?
- airway anomalies
- How many people
- 999 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 May 2022to 31 Dec 2024
- How long will I take part?
- 5 Years
- 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 0 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All pediatric patients (age <18 years) who underwent surgery for CHD at our hospital between January 1, 2017, and December 31, 2020
Who may be able to join
- all pediatric patients (age <18 years) who underwent surgery for CHD at our hospital between January 1, 2017, and December 31, 2020.
Who cannot join
- with much missing clinical data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Epidemiology, Risk Factors, and Prognosis of Pediatric Patients After Operations for Congenital Heart Disease
This hospital-based retrospective study reviewed patients who underwent surgery for CHD between 2017 and 2020 and analyzed the clinical features and outcomes associated with airway anomalies.
- Conditions
- Congenital Heart Disease, Pediatric
- Being tested
- airway anomalies
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airway anomaliesOther
with or without airway anomalies
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical mortality
hospital expired after operation
Measured: 1 year
intermediate survival
expired during follow-up
Measured: 5 years
Secondary outcomes (2)
post-operative ICU stay
The length of ICU stay after operation
Measured: 1 year
post-operative intubated days
The length of intubated days after operation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start15 May 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Other
- Enrolment
- 999 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031831
- Sponsor's protocol ID
- 202205043RINB
- Status last verified
- May 2023
- First submitted
- 4 Sep 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Epidemiology, Risk Factors, and Prognosis of Pediatric Patients After Operations for Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT06031831
- Acronym / sponsor ID
- 202205043RINB
- Conditions
- Congenital Heart Disease, Pediatric
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 999 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 11 Sep 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.
This hospital-based retrospective study reviewed patients who underwent surgery for CHD between 2017 and 2020 and analyzed the clinical features and outcomes associated with airway anomalies.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 0 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All pediatric patients (age <18 years) who underwent surgery for CHD at our hospital between January 1, 2017, and December 31, 2020
Key inclusion criteria (1 listed)
- all pediatric patients (age <18 years) who underwent surgery for CHD at our hospital between January 1, 2017, and December 31, 2020.
Key exclusion criteria (1 listed)
- with much missing clinical data
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 |
|---|---|---|
| airway anomalieswith or without airway anomalies | Other | – |
Primary outcome
surgical mortality
Time frame: 1 year
hospital expired after operation
intermediate survival
Time frame: 5 years
expired during follow-up
2 secondary outcomes
post-operative ICU stay
Time frame: 1 year
post-operative intubated days
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Pediatric, run by National Taiwan University Hospital at 1 site in Taiwan.
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 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
surgical mortality (time frame: 1 year). The study lists 2 primary outcomes in all. 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 11 Sep 2023.