Auscultation and Pulse Oximetry Combined Screening of Neonatal Congenital Heart Disease

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05105880

Enrollment

40000

Registered

2021-11-03

Start date

2018-01-01

Completion date

2020-07-01

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Keywords

Pulse oximetry, Auscultation, Congenital Heart Disease, Screening

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Hours to 72 Hours

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

China

Outcome results