Oxygen Saturation
Conditions
Brief summary
Objective: Objective of this pilot feasibility study is to monitor crSO2 using NIRS INVOS 5100 (Somanetics, USA) in addition to SpO2 monitoring to guide supplemental oxygen delivery and respiratory support based on both measurements in preterm neonates during the first 15 minutes after birth. Patients: Preterm neonates \<34+0 weeks of gestation born via caesarean section and/or who require respiratory support will be eligible for the study. Design: A prospective two-centre randomized controlled pilot feasibility study Methods: Study group: Pulse oximetry will be used to measure SpO2 and heart rate as routine non-invasive monitoring in the first minutes of resuscitation. In addition during the first 15 minutes NIRS measurements will be recorded. crSO2 measurements in addition SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth. Control group: Only SpO2 measurements will be used to guide supplemental oxygen support and respiratory support during the first 15 minutes after birth. Hypothesis: Supplemental oxygen support and respiratory support guided by crSO2 and SpO2 measurements will reduce the time in % minutes of crSO2 \<10th or \>90th centile in preterm neonates during the first 15 minutes after birth Outcome Parameter: Primary outcome parameter will be duration in % minute of crSO2 \<10th or \>90th centile.
Interventions
DEVICENear Infrared Spectroscopy
If crSO2 is \<10th centile, CPAP via face mask will be started or oxygen support will be increased depending SpO2, on the infants breathing efforts and the heart rate. If crSO2 remains stable \>10th centile, or if crSO2 is \> 90th centile CPAP via face mask will be stopped or FiO2 will be reduced depending on SpO2, the infants breathing efforts and the heart rate.
DEVICEPulse-oximetry
If SpO2 remains \<10th centile, respiratory support via face mask will be started or FiO2 will be increased depending on the infants breathing efforts and the heart rate. If SpO2 remains stable or if SpO2 is \>90th centile respiratory support via face mask will be stopped or FiO2 will be reduced depending on the infants breathing efforts and the heart rate.
Sponsors
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 15 Minutes
Healthy volunteers
No
Inclusion criteria
* Preterm neonate \<34+0 weeks after caesarean section * Decision to conduct full life support * Written informed consent
Exclusion criteria
* No decision to conduct full life support * No written informed consent * Congenital malformation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral tissue oxygen saturation (crSO2) | 15 minutes | Duration in % minute of crSO2 \<10th or \>90th centile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 16 weeks | Rate of mortality |
| Cerebral injury | 16 weeks | Cerebral injury assessed by sonography |
| Neurodevelopmental outcome | 16 weeks | General movements |
Other
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | 16 weeks | Severe morbidities, Rate of intubation during resuscitation, Need of mechanical ventilation on the first day of life, Monitoring parameters during the first 15minutes after birth: Mean (SD) HR, Mean (SD) BP, Mean (SD) SpO2, NIRS parameters |
Countries
Austria, Canada
Outcome results
None listed