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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51115

Enrollment

Registered

2021-05-21

Start date

2021-07-15

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prematurity skin damage

Interventions

None listed

Eligibility

Age

2 Years to 11 Years

Inclusion 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) cohort that is not already fully represented in the study (to include representative numbers, inclusion is performed in three cohorts (37 weeks PMA))

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Skin condition as defined by Trans epidermal water loss	—

Secondary

Measure	Time frame
Visual inspection of the skin using the Neonatal Skin Condition Score (NSCS) and adverse event-reporting (if any)	—

Countries

Netherlands

Outcome results