Auscultation and Pulse Oximetry Combined Screening of Neonatal Congenital Heart Disease

Completed

• Conditions: Congenital Heart Disease

• Registration Number: NCT05105880
• Lead Sponsor: Women and Children's Hospital of Linyi City

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-07-01
• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-22
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-02
• Study First Posted: 2021-11-03
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severe congenital heart disease	The first 24 hours after birth.	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.

Trial Locations

Locations (1)

Women and Children's Hospital of Linyi City; 🇨🇳 Linyi, Shandong Provicne, China