Skin condition assessment during routine monitoring versus during wearing of the BAMBI BELT; a wireless device measuring neonatal heart rate, ECG and respiratio

Completed

• Conditions: prematurity; skin damage; 10028920; 10014982

• Registration Number: NL-OMON51115
• Lead Sponsor: Maxima Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Skin condition as defined by Trans epidermal water loss </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Visual inspection of the skin using the Neonatal Skin Condition Score (NSCS)<br /><br>and adverse event-reporting (if any) </p><br>