No registrations found.
ID
Source
Brief title
Health condition
Prematurity
Sponsors and support
Intervention
Outcome measures
Primary outcome
Transepidermal water loss
Secondary outcome
Neonatal skin condition score
Background summary
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.
Study objective
A wearable, non-adhesive wireless belt is skin friendlier compared to routine adhesive electrodes meant for cardiorespiratory monitoring in neonates.
Study design
Study duration is 10 days. Primary and secondary outcome measures are determined daily.
Intervention
Wearing of wearable belt for 10 days
Inclusion criteria
• 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)
Exclusion criteria
• 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9478 |
| Other | METC MMC : W21.043 |