To compare skin condition for monitoring with the Bambi Belt versus skin condition with routine monitoring.
ID
Source
Brief title
Condition
- Neonatal and perinatal conditions
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Skin condition as defined by Trans epidermal water loss
Secondary outcome
Visual inspection of the skin using the Neonatal Skin Condition Score (NSCS)
and adverse event-reporting (if any)
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.
Study objective
To compare skin condition for monitoring with the Bambi Belt versus skin
condition with routine monitoring.
Study design
Prospective observational within-subject study in Máxima Medical Center.
Subjects will be allocated to a study ID and wear the Bambi belt (a part of the
Bambi Belt System) for 10 consecutive days, in addition to standard monitoring
with adhesive electrodes.
Study burden and risks
Non-invasive, observational study in which infants have to wear an additional
monitoring device. Although unexpected, the risk of skin irritation due to this
device cannot be ruled out. There are no benefits for participating infants.
This study might demonstrate substantial benefits for a similar population in
the near future. These potential benefits outweigh the minimal risks.
De Run 4600
Veldhoven 5504 DB
NL
De Run 4600
Veldhoven 5504 DB
NL
Listed location countries
Age
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) cohort that is not already fully
represented in the study (to include representative numbers, inclusion is
performed in three cohorts (< 28 weeks PMA, between 28-37 weeks, and >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
Medical products/devices used
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 |
|---|---|
| CCMO | NL77561.015.21 |