sick newborns/neonates
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
2 Years to 11 Years
Inclusion 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 • Informed consent from parents or caregivers
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the heart rate. The primary endpoint is the agreement of heart rate monitoring between innovative PPG technology integrated in a cap and standard heart rate monitoring using regular thoracic ECG electrodes. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Time interval between birth and the first adequate registration of the heart rate • Time interval between application of monitoring device and adequate registration of the heart rate • Feasibility, accuracy and precision when the innovative cap is used in an infant who is supported by invasive or non-invasive respiratory support (e.g. nCPAP, NiPPV, HFO-V). | — |
Countries
Netherlands
Outcome results
None listed