A wearable, non-adhesive wireless belt is skin friendlier compared to routine adhesive electrodes meant for cardiorespiratory monitoring in neonates.
ID
Bron
Verkorte titel
Aandoening
Prematurity
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Transepidermal water loss
Achtergrond van het onderzoek
In sick or prematurely born neonates, cardiorespiratory monitoring is routinely performed using adhesive electrodes. Especially in neonatal intensive care units (NICUs), where all infants require monitoring, alternative monitoring methods are desired to replace such skin unfriendly adhesive electrodes, attached to hindering wires. In this study, the skin friendliness of one such alternatives is compared to skin friendliness of routine monitoring with adhesive electrodes.
Doel van het onderzoek
A wearable, non-adhesive wireless belt is skin friendlier compared to routine adhesive electrodes meant for cardiorespiratory monitoring in neonates.
Onderzoeksopzet
Study duration is 10 days. Primary and secondary outcome measures are determined daily.
Onderzoeksproduct en/of interventie
Wearing of wearable belt for 10 days
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• Being admitted to the NICU
• Being routinely monitored with adhesive electrodes
• Having written parental informed consent
• Being of a post-menstrual age (PMA) that is not already fully represented in the study (representative numbers of three cohorts are included, < 28 weeks PMA, between 28-37 weeks PMA, > 37 weeks PMA)
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 that prevent placement of the belt.
• Effects of surgery preventing or hindering belt placement, such as laparotomy or stoma
• Contraindications of the Bambi Belt, i.e. use during MRI and electrosurgery
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL9478 |
| Ander register | METC MMC : W21.043 |