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NCT05105880 Clinical Trial

Auscultation and Pulse Oximetry Combined Screening of Neonatal Congenital Heart Disease

Congenital Heart Disease Clinical Trial

Official title:
The Effectiveness of Cardio-auscultation and Pulse Oximetry Combined Screening of Congenital Heart Disease in Newborns

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05105880
Other study ID # CHDScreening
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date July 1, 2020

Study information
Verified date November 2021
Source Women and Children's Hospital of Linyi City
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigators conducted this retrospective study in a large single center with an annual birth of more than 20,000 newborns, from January 1, 2018 to December 31, 2019, to confirm the applicability and accuracy of pulse oximetry (POX) combined cardio-auscultation to screen congenital heart disease for neonates.

Description:

All consecutive newborn babies were eligible, irrespective of gestational age, NICU admission, symptom presence or prenatal diagnosis. This study was approved by institutional ethical review board of Linyi Maternal and Child Healthcare Hospital. Spoken informed consent was obtained from the participating babies' parents. Physicians from departments of neonatal medicine and developmental medicine undertake auscultation screening. When abnormal murmur occurred, an echocardiography would be requested to confirm if the newborn has CHD or not. Physicians from obstetrics department and nursing staff from neonatal department undertake POX measurement. If a positive POX occurred, an echocardiography would be requested to confirm if the newborn has CHD or not. Physicians from department of ultrasonography undertake echocardiography confirmation for newborns deemed positive by auscultation or POX.

Recruitment information / eligibility
Status Completed
Enrollment 40000
Est. completion date July 1, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 72 Hours
Eligibility Inclusion Criteria: - All consecutive newborn babies delivered in the study center were eligible, irrespective of gestational age, NICU admission, symptom presence or prenatal diagnosis. Exclusion Criteria: - None.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Women and Children's Hospital of Linyi City Linyi Shandong Provicne

Sponsors (1)
Lead Sponsor Collaborator
Women and Children's Hospital of Linyi City

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Severe congenital heart disease Patients who present as severely ill in the newborn period or early infancy, including those with cyanotic heart disease and acyanotic lesions like AVSD, large VSD, large PDA, critical or severe AS, severe PS, critical coarc. The first 24 hours after birth.
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