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Respiratory Support System Triggered by Bio-impedance and Myography for Preterms and Neonates

Respiratory Support System Triggered by Bio-impedance and Myography for Preterms and Neonates - BigAtheNe

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00016470
Enrollment
40
Registered
2019-08-02
Start date
2019-08-09
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

P28.4

Interventions

Group 1: Non-interventional observational study. Preterms on non-invasive ventilatory support and with frequent apneas will be prospectively enrolled. We will Monitor movements of the abdominal wall,

Sponsors

Universitätsklinikum Leipzig
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 6 Months

Inclusion criteria

Inclusion criteria: Term and preterm neonates on non-invasive ventilatory Support (CPAP or NIPPV). Enteral Nutrition via gastric tube. Written informed consent by preferably both parents.

Exclusion criteria

Exclusion criteria: Severe malformations of the Thorax, the Abdomen or inner Organs. Numerical chromosome aberrations. Acute Sepsis and/or severely reduced general condition. Severe pulmonary problems (e.g. edema, atelectasis, Pneumothorax).

Design outcomes

Primary

MeasureTime frame
By measuring EMG of the diaphragm and bioimpedance of the throat muscles together with clinical date and vital signs (recorded during Standard Monitoring bei the Ventilator and the bed-side Monitor), this study's aim is to create an algorithm, that enables a ventilator to detect and classifiy apneas.

Secondary

MeasureTime frame
See above

Countries

Germany

Contacts

Public ContactUlrich Thome

Universitätsklinikum Leipzig

ulrich.thome@medizin.uni-leipzig.de0049 341 97 23585

Outcome results

None listed

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