NL-OMON28282
Not yet recruiting
Not Applicable
Skin condition assessment during routine monitoring versus during wearing of the BAMBI BELT; a wireless device measuring neonatal heart rate, ECG and respiration
Máxima Medical Center0 sites15 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Máxima Medical Center
- Enrollment
- 15
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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