Wireless wearable belt for neonatal monitoring

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28282

Enrollment

Registered

2021-05-14

Start date

2021-06-16

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Prematurity

Interventions

Wearing of wearable belt for 10 days

Eligibility

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) that is not already fully represented in the study (representative numbers of three cohorts are included, 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
Transepidermal water loss	—

Secondary

Measure	Time frame
Neonatal skin condition score	—

Contacts

Public ContactDeedee Kommers

Máxima Medical Center

Deedee.Kommers@mmc.nl040 888 93 50

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)