The monitoring performance of a wireless alternative for cardiorespiratory monitoring in neonates is equivalent (non-inferior) compared to routine monitoring with adhesive electrodes.
ID
Bron
Verkorte titel
Aandoening
Prematurity
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
a) Equivalence of heart rate monitoring (as measured by i) second-to-second correlation and level of agreement, and ii) bradycardia and tachycardia sensitivity and positive predictive value (PPV)) and
b) Safety (as measured by data loss and pre-defined relevant adverse events and adverse device effects).
Achtergrond van het onderzoek
In sick or prematurely born neonates, monitoring of the heart rate, ECG, and respiration is routinely performed using adhesive electrodes that obtain the electrical activity of the heart and chest impedance. Especially in neonatal intensive care units (NICUs), where all infants require monitoring, alternative monitoring methods are desired to replace such obtrusive adhesive electrodes, attached to hindering wires. In this study, the aim is to establish non-inferiority of the monitoring performance of an alternative, wireless monitoring device.
Doel van het onderzoek
The monitoring performance of a wireless alternative for cardiorespiratory monitoring in neonates is equivalent (non-inferior) compared to routine monitoring with adhesive electrodes.
Onderzoeksopzet
Additional monitoring with the belt is performed for 24 hours continuously. The study ends after these 24 hours, there is no follow up.
Onderzoeksproduct en/of interventie
Additional (non-invasive) monitoring with a wireless, wearable, biocompatibile belt
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Admitted to a participating NICU
• Being routinely monitored using adhesive electrodes for cardiorespiratory monitoring
• Written parental informed consent
• Of a post-menstrual age that is not already fully represented in the study (to include a representative sample, inclusion is performed in three cohorts, <28 weeks, between 28-37 weeks, > 37 weeks)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• Chest skin lesions preventing placement of electrode belt, since the intended use of the belt is for intact skin.
• Congenital anomalies preventing placement of electrode belt
• (Effects of) surgery preventing or hindering belt placement, such as a laparotomy or stoma
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9480 |
| Ander register | METC MMC : W21.042 |