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Auscultation and Pulse Oximetry Combined Screening of Neonatal Congenital Heart Disease

Sponsor
Women and Children's Hospital of Linyi City (Other)
Overall Status
Completed
CT.gov ID
NCT05105880
Collaborator
(none)
40,000
Enrollment
1
Location
30
Actual Duration (Months)
1335
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    40000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    The Effectiveness of Cardio-auscultation and Pulse Oximetry Combined Screening of Congenital Heart Disease in Newborns
    Actual Study Start Date :
    Jan 1, 2018
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Jul 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Hours to 72 Hours
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Women and Children's Hospital of Linyi City Linyi Shandong Provicne China

    Sponsors and Collaborators

    • Women and Children's Hospital of Linyi City

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Women and Children's Hospital of Linyi City
    ClinicalTrials.gov Identifier:
    NCT05105880
    Other Study ID Numbers:
    • CHDScreening
    First Posted:
    Nov 3, 2021
    Last Update Posted:
    Nov 8, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Women and Children's Hospital of Linyi City
    Pulse oximetry
    Auscultation
    Congenital Heart Disease
    Screening
    Additional relevant MeSH terms:
    Heart Diseases
    Heart Defects, Congenital

    Study Results

    No Results Posted as of Nov 8, 2021