Study of cardiac murmurs and abnormal heart sounds

JRCT ID: jRCT1052230122

Registered date:31/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: All children born in our hospital are eligible, regardless of disease status.
• Date of first enrollment: 31/10/2023
• Target sample size: 400
• Study type: Interventional
• Intervention(s): Perform additional ultrasound examinations that are not usually performed.

Outcome(s)

• Primary Outcome: Heartbeat/electrocardiogram of a newborn baby measured by AMI-SSS01 series

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >=
• Age maximum: <= 2month old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Maehana Tomoka
• Source(s) of Monetary Support: AMI Inc.