Neonatal Respiratory Distress, Very Low Birth Weight Infant
Conditions
Keywords
SpO2 Target Range, pulse oximetry, automatic oxygen control
Brief summary
The aim of the study is to determine if a narrower SpO2 Target Range setting automated control of FiO2 (A-FiO2) is more effective than a wider SpO2 Target Range
Detailed description
A-FiO2 systems have consistently proven to be more effective than manual control. Because it is more precise than manual control, studies of some A-FiO2 systems found small differences in the set target range (shift in the median and width) can optimize the relative performance. Similar studies of the A-FiO2 system (PRICO) used in the investigator's NICU have not been conducted. The standard of practice in the investigator's NICU is to use 4 different target ranges to balance the risk of hypoxia and hyperoxia based on the gestational age vulnerabilities. Based on the studies of other A-FiO2 systems the investigators believe a slightly narrower width target range would be more effective. Therefore, a small systematic study is needed to determine the optimal set target range to achieve the therapeutic goal.
Interventions
DEVICENarrow TR
The width of the PRICO SpO2 TR is set to 3% SpO2.
DEVICEShifted TR
The lower and the upper limits of the PRICO SpO2 TR are increased by 1% SpO2.
Sponsors
Czech Technical University in Prague
University Hospital, Motol
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Subjects will be switched between the standard target range, the narrow target range, and the target range with a higher median every 12 hours. The sequence will be randomized differently for each subject, with a balanced block design such that every 3 days each range is evaluated twice. Once enrolled, each subject will continue in the study with regular changes in averaging time through the course of their need for A-FiO2 or 30 days, whichever is shorter. All other elements of care will be as routinely used.
Eligibility
Sex/Gender
ALL
Age
2 Weeks to No maximum
Healthy volunteers
No
Inclusion criteria
* All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after informed consent is obtained.
Exclusion criteria
* Informed consent is not obtained * Recording device for automated control of FiO2 is not available
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent time in the set SpO2 target range | 30 days of intervention if possible | Percent time in the set SpO2 target range (compliance). Periods with SpO2 higher than the target range with FiO2 = 0.21 will be included in the target range compliance. |
| Percent time at SpO2 ≤80% and >98% | 30 days of intervention if possible | Percent time at SpO2 ≤80% and \>98% (safety). Periods with SpO2 higher than 98% with FiO2 = 0.21 will be excluded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent time above the set SpO2 target range | 30 days of intervention if possible | Percent time above the set SpO2 target range. Periods with SpO2 higher than the target range with FiO2 = 0.21 will be excluded from time above the target range. |
| Percent time below the set SpO2 target range | 30 days of intervention if possible | Percent time below the set SpO2 target range. |
Countries
Czechia
Contacts
PRINCIPAL_INVESTIGATOREkaterina Orlova, MD
Motol University Hospital Prague, Neonatal Unit
PRINCIPAL_INVESTIGATORJan Janota, MD, PhD
Motol University Hospital Prague, Neonatal Unit
PRINCIPAL_INVESTIGATORThomas E Bachman, MSc
Czech Technical University in Prague
PRINCIPAL_INVESTIGATORJana Dornakova, MD
Motol University Hospital Prague, Neonatal Unit
Outcome results
None listed