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ECHO-Check: Comparison of echocardiography using handheld ultrasound with standard devices in mature newborns

ECHO-Check: Comparison of echocardiography using handheld ultrasound with standard devices in mature newborns - ECHO-Check

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00034698
Enrollment
100
Registered
2024-09-02
Start date
2024-09-09
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Comparison of echocardiography with handheld ultrasound devices and standard devices

Interventions

Group 1: Newborns without prenatally or perinatally diagnosed heart disease receive a cardiac ultrasound with a handheld device and a standard device at one point in time. The children are recruited f

Sponsors

Klinikum der Universität München, Campus Großhadern
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Days to 12 Weeks

Inclusion criteria

Inclusion criteria: Newborns without prenatally or perinatally diagnosed heart disease may participate after informed consent has been obtained from their parents. The children are recruited from the neonatology ward at Großhadern Hospital and the Dr von Hauner Children's Hospital. The minimum age is set at 48 hours in order to wait for spontaneous closure of the ductus arteriosus botalli.

Exclusion criteria

Exclusion criteria: Children with prenatally known heart defects are excluded from the study. In addition, children for whom a comprehensive ultrasound examination is not fully possible (for technical reasons or because the child becomes restless) are subsequently excluded.

Design outcomes

Primary

MeasureTime frame
- Subjective image quality - Image quality related to the visibility of the mitral valve and tricuspid valve structures (valve leaflets and chordae tedineae) - Comparison of measurements in B-mode (tricuspid valve annulus, mitral valve annulus, aortic valve annulus) - Comparison of measurements in M-mode (e.g. LA to Ao)

Secondary

MeasureTime frame
- Quality of the colour Doppler - User friendliness

Countries

Germany

Contacts

Public ContactAdelheid Kley

Klinikum der Universität München, Campus Großhadern

adelheid.kley@med.uni-muenchen.de+4989440073941

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026