geen aandoening, onderzoek met gezonde deelnemers nvt
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Healthy children between 0 - 5 years, Indian and African heritage would be preferred but not mandatory, since the probe would be targeting India and Africa.
Exclusion criteria
Exclusion criteria: Subjects carrying or wearing any supportive or medical device in the area that the probe is going to be placed or subjects missing or with a physical deformity in that extremity (feet or finger). Subjects with childhood asthma, cardiovascular diseases, heart murmur or any type of medication (excluding medication without a prescription).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is achieved when the signal strength for each probe (belly, forehead, finger, and heel) in each age category (0-2 months, 2-36 months, and 36-60 months) is determined in order to compare the signal strength with our reference value from the null-hypotheses H0: the signal strength is 0.4%. The signal strength is defined as the pulse height of the infrared light divided by its slowly-varying baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is achieved when the user aspects per probe and age group are determined to a level that any frequently occurring disadvantage of a probe would be identified. | — |
Countries
Netherlands