Analysis of Risk Factors and Prognosis of Pediatric Patie... | NCT06031831

Studies
Analysis of Risk Factors and Prognosis of Pediatric Patients After Operations for Congenital Heart Disease

NCT06031831

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Sep 11, 2023Actual

Enrollment

999Estimated

Phase

Not provided

Conditions

Congenital Heart Disease
Pediatric

Interventions

airway anomalies

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2022Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Sep 4, 2023

First Submission Date that Met QC Criteria

Sep 4, 2023

First Posted Date

Sep 11, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 4, 2023

Last Update Posted Date

Sep 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

999Estimated

Name	Type	Description	Arm Group Labels	Other Names
airway anomalies	Other	with or without airway anomalies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
surgical mortality	hospital expired after operation	1 year
intermediate survival	expired during follow-up	5 years

Secondary Outcomes

Measure	Description	Time Frame
post-operative ICU stay	The length of ICU stay after operation	1 year
post-operative intubated days	The length of intubated days after operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all pediatric patients (age <18 years) who underwent surgery for CHD at our hospital between January 1, 2017, and December 31, 2020.

Exclusion Criteria:

with much missing clinical data

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Days

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

All pediatric patients (age <18 years) who underwent surgery for CHD at our hospital between January 1, 2017, and December 31, 2020

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jenghung Wu		Taipei	Taiwan R.	100229	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006330	Heart Defects, Congenital

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases
D000013	Congenital Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided