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Study of cardiac murmurs and abnormal heart sounds

The study of constructing neonatal heart sound/electrocardiogram database using AMI-SSS01 series

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1052230122
Enrollment
400
Registered
2023-10-31
Start date
2023-10-31
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

All children born in our hospital are eligible, regardless of disease status. Congenital heart disease, cardiac murmur, neonates, newborns

Interventions

Perform additional ultrasound examinations that are not usually performed.

Sponsors

Maehana Tomoka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Name of disease and diagnostic method: All newborns born in this hospital are eligible, regardless of the name of the disease. Stages, types, and conditions of disease: Not applicable. Gender and age: Intervention is considered at day age 00-1, regardless of gender. Pre-treatment: Not applicable Indicators of systemic status: N/A Relevant major organ function: heart Written consent of the study subjects: 1. As this is a study of newborns, surrogate consent will be obtained from the biological mother. The biological mother will be fully informed of the study and her consent will be obtained based on her full understanding of the study. 2. The expectant mother must be at least 18 years of age at the time of consent.

Exclusion criteria

Exclusion criteria: 1. children with skin diseases of the anterior thoracic region 2. children with anterior chest wounds 3. children with unstable general condition 4. other children who are deemed inappropriate by the physician

Design outcomes

Primary

MeasureTime frame
Heartbeat/electrocardiogram of a newborn baby measured by AMI-SSS01 series

Secondary

MeasureTime frame
Whether neonatal cardiac diseases have different acoustic features Whether neonatal cardiac diseases can be diagnosed only by heart sounds/electrocardiograms obtained by the AMI-SSS01 series. Whether neonatal cardiac diseases can be diagnosed by combining the heart sound/electrocardiogram obtained by the AMI-SSS01 series with auscultation findings, presence of respiratory disturbance, and blood oxygen saturation. Whether or not the presence of patent ductus arteriosus can be diagnosed by using only heart sounds/electrocardiograms obtained with the ultrathoraxial stethoscope. Whether or not it is possible to diagnose patent ductus arteriosus by combining cardiac sounds/electrocardiograms obtained by AMI-SSS01 series with auscultatory findings, presence/absence of respiratory disturbance, and blood oxygen saturation.

Contacts

Public ContactTomoka Maehana

Nara Medical University

tmaehana@naramed-u.ac.jp+81-744-29-8877

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026