NCT04899596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

3 months

First QC Date

May 5, 2021

Last Update Submit

May 21, 2021

Conditions

Neonatal Arrhythmia

Outcome Measures

Primary Outcomes (5)

  • 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

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Age1 Minute - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

neonates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chongqing, Chongqing Municipality, 400042, China

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Study Record Dates

First Submitted

May 5, 2021

First Posted

May 24, 2021

Study Start

October 1, 2019

Primary Completion

December 31, 2019

Study Completion

December 31, 2020

Last Updated

May 24, 2021

Record last verified: 2021-05

Locations

CN(1)