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Clinical Trials/NL-OMON28282
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Observational non invasive

Investigators

Sponsor
Máxima Medical Center

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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