Preterm Infant, RDS
Conditions
Brief summary
In this study the investigators test the hypothesis that automated FiO2 adjustment increases the time of brain tissue oxygenation within the intended reference range. Furthermore, the investigators studied the change in workload during automated FiO2 adjustment as compared to manual adjustment by the nursing staff.
Detailed description
Recorded data on brain tissue oxygenation will be compared with reference data obtained from other studies. Data from experimental mode (automated FiO2 control will be compared with manual FiO2 control).
Interventions
DEVICEAutomated FiO2 Control
Infants will be ventilated with or without automated FiO2-Control in a randomized sequence.
Sponsors
University of Ulm
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
96 Hours to 30 Weeks
Healthy volunteers
No
Inclusion criteria
* postmenstrual age \<30 wks GA at study time * on nasal/nasopharyngeal CPAP or mechanical ventilation (including nasopharyngeal IMV) * at least 4 desaturations (SpO2 \<80%) during an 8 hour period within the 24h before the study using a standard pulse oximeter incorporated in the NICU (Dash 3000, General Electric, Freiburg; 10s averaging time, delay 10s)
Exclusion criteria
* postnatal age \<96h (to exclude rapidly changing conditions during the early phase of RDS and to avoid handling of the infant during the critical period for IVH) * congenital cyanotic heart disease * no decision for full treatment support * Average FiO2 during the last 24h bevor the active study phase \>0.60 * Congenital malformations of the lung or the diaphragm (i.e. diaphragmatic hernia, congentital cystic lung diseases...) * Clinically clear evidence for seizures * Ongoing Sepsis (CRP \> 10mg/l, or positive blood culture, requirement of catecholamines) * Need of blood-transfusion during study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral tissue oxygen saturation | 48 hours | mean cerebral tissue oxygen saturation as well als distribution of cerebral tissue oxygen saturation over time will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number and mean duration of episodes with an SpO2 <80%, <75%, <70% and with hyperoxemia (SpO2 >96%) | 48 hours | The number and mean duration of expisodes of desaturation and with hyperoxemia will be assessed |
| time within a defined target range of cerebral oxygen saturation (59% - 81%) | 48 hours | time (as measured as the percentage of the total recording time) within a defined target range of cerebral oxygen saturation (59% - 81%) which corresponds to the 10th and 90th percentile obtained from a pilot study in 16 preterm infants with desaturations during the time when their SpO2 was aimed within the target range of a SpO2 of (88-96%). |
| workload for the medical staff related to number of adjustments of FiO2 | 48 hours | — |
Countries
Germany
Outcome results
None listed