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Clinical Trials/NL-OMON49842
NL-OMON49842
Recruiting
Not Applicable

Heart rate registration in neonates using a PPG-integrated cap - Well hatted

Radboud Universitair Medisch Centrum0 sites120 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Radboud Universitair Medisch Centrum
Enrollment
120
Status
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

Eligibility Criteria

Inclusion Criteria

  • In order to be eligible to participate in this study, a subject must meet all
  • of the following criteria:
  • Gestational age
  • a. group 1: neonates born at a gestational age of \>\=32 weeks with standard
  • cardiorespiratory monitoring.
  • b. group 2: neonates born at a gestational age of \>\=26 weeks with or without
  • nCPAP (Nasal continuous positive airway pressure).
  • c. Phase 2/ group 3: Extreme preterm infants born at a gestational age between
  • 24 and 26 weeks.
  • d. Group 4: Term and preterm newborn infants at birth

Exclusion Criteria

  • A potential subject who meets any of the following criteria will be excluded
  • from participation in this study:
  • nCPAP (group 1\)
  • Cerebral Function Monitoring (group 1, 2 and 3\)
  • Peripheral intravenous catheter located on the skull (group 1, 2 and 3\)
  • Skin lesions on the skull
  • Life\-threatening congenital defects

Outcomes

Primary Outcomes

Not specified

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