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Clinical Trials/NL-OMON51115
NL-OMON51115
Completed
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 - Skin condition and neonatal monitoring

Maxima Medisch Centrum0 sites15 target enrollmentTBD
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Conditionsprematurityskin damage1002892010014982

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
prematurity
Sponsor
Maxima Medisch Centrum
Enrollment
15
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

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
Maxima Medisch Centrum

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) 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

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
  • •\* Contraindications of the Bambi Belt, i.e. use during MRI and electrosurgery

Outcomes

Primary Outcomes

Not specified

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