Heart rate registration in neonates using a PPG-integrated cap
- Conditions
- sick newborns/neonates10028920
- Registration Number
- NL-OMON49842
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
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
• Informed consent from parents or caregivers
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
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is the heart rate. The primary endpoint is the<br /><br>agreement of heart rate monitoring between innovative PPG technology integrated<br /><br>in a cap and standard heart rate monitoring using regular thoracic ECG<br /><br>electrodes.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Time interval between birth and the first adequate registration of the heart<br /><br>rate<br /><br>• Time interval between application of monitoring device and adequate<br /><br>registration of the heart rate<br /><br>• Feasibility, accuracy and precision when the innovative cap is used in an<br /><br>infant who is supported by invasive or non-invasive respiratory support (e.g.<br /><br>nCPAP, NiPPV, HFO-V).</p><br>