High Risk Factor, Clinical Feature, and Follow up of Neon... | NCT04899596

Studies
High Risk Factor, Clinical Feature, and Follow up of Neonatal Arrhythmia

NCT04899596

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Status

Completed

Last Update Posted

May 24, 2021Actual

Enrollment

1Actual

Phase

Not provided

Conditions

Neonatal Arrhythmia

Interventions

No intervention

Countries

China

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 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2019Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

May 5, 2021

First Submission Date that Met QC Criteria

May 21, 2021

First Posted Date

May 24, 2021Actual

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

May 21, 2021

Last Update Posted Date

May 24, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityPrincipal Investigator

Lead Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityOTHER

Collaborators

Name	Class
Children's Hospital of Chongqing Medical University	OTHER

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 study included 189 newborns (77 male,112 female) diagnosed with arrhythmia in the NICU of Children's Hospital of Chongqing Medical University, China, from January 2015 through December 2019. To investigate the high-risk factors, clinical manifestations, and clinical outcomes of neonatal arrhythmia.

Detailed Description

The incidence of neonatal arrhythmia is 3.94‰(189/47911), and the mortality of neonatal arrhythmia is 0.21‰(10/47911) within 1 year after birth.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	No intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Electrocardiogram	A 12-lead electrocardiogram or dynamic electrocardiogram	up to 12 weeks
anti-arrhythmia	Use antiarrhythmic medications	before 1 year old
death	neonates died	up to 12 weeks
death	neonates died	before 1 year old
recurrence	Arrhythmia occurs again	before 1 year old

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:①Newborns admitted in the Department of Neonatology of Children's Hospital Affiliated to Chongqing Medical University from January 2015 to December 2019;② 12-lead ECG and/or 24-hour dynamic ECG suggest arrhythmias, including children with sinus tachycardia and sinus arrhythmia.

Exclusion Criteria:not have

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

28 Days

Standard Ages

Child

Study Population

neonates

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University		Chongqing	Chongqing Municipality	400042	China

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