hypoxie en hyperoxie bij prematuriteit neonatal hypoxia and hyperoxia
Conditions
Interventions
Automated adjustment of the inspired oxygen during 24 hours
Sponsors
Academisch Medisch Centrum
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: - born with a gestational age between 24 and 32 weeks. - weight at study entry between 0.4 to 4 kilograms. - receiving invasive mechanical ventilation or non-invasive respiratory support (NCPAP or NIPPV). - receiving supplemental oxygen at the time of enrollment and for at least 18 hours during the previous 24 hours. - expected to complete the 48 hour study period in the current form of respiratory support, i.e. invasive mechanical ventilation or non-invasive respiratory support. - written informed parental consent.
Exclusion criteria
Exclusion criteria: - major congenital anomalies - arterial hypotension requiring vasopressor therapy within 48 hours prior to enrollment. - culture proven sepsis within 72 hours prior to enrollment. - if the attending physician deems participation in the study is not in the best interest of the infant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of time with SpO2 within the assigned target range | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Oxygen saturation distribution 2. Fraction of Inspired Oxygen (FiO2) 3. Time with FiO2 at 21% 4. Oxygen saturation variability 5. Assessment of staff effort 6. Adherence to guidelines 7. Extended episodes with oxygen saturation below or above the target range 8. Incidence of episodes and time with oxygen saturation below the target range 9. Incidence of episodes and time with oxygen saturation above the target range 10. Assessment of response to SpO2 signal loss 11. Assessment of overshoot | — |
Countries
Netherlands
Outcome results
None listed