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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease

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 Type: Observational
• Enrollment (Actual): 40000

Contacts and Locations

Study Locations

• China
  • Shandong Provicne
    • Linyi, Shandong Provicne, China
      • Women and Children's Hospital of Linyi City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 3 days (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population focus on the neonates delivered in the two campuses of the study center which is the largest maternal facility in a municipality of 11 million population.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Women and Children's Hospital of Linyi City

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Screening; Auscultation; Pulse oximetry
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: CHDScreening

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No