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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Near Infrared Spectroscopy | Experimental | crSO2 measurements in addition SpO2 measurements will be visible to guide supplemental oxygen support and respiratory support according predefined interventions depending on the infants breathing efforts and the heart rate during the first 15 minutes after birth |
|
| Pulse-oximetry | Other | Only SpO2 measurements will be visible to guide supplemental oxygen support and respiratory support according predefined interventions depending on the infants breathing efforts and the heart rate during the first 15 minutes after birth |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Near Infrared Spectroscopy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral tissue oxygen saturation (crSO2) | Duration in % minute of crSO2 <10th or >90th centile | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Rate of mortality | 16 weeks |
| Cerebral injury | Cerebral injury assessed by sonography | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | 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 | 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerhard Pichler, MD | Dep. of Pediatrics, Medical University of Graz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Medical University of Graz | Graz | Styria | 8036 | Austria | ||
| Department of Pediatrics, Royal Alexandra Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26743498 | Derived | Pichler G, Urlesberger B, Baik N, Schwaberger B, Binder-Heschl C, Avian A, Pansy J, Cheung PY, Schmolzer GM. Cerebral Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates for the Immediate Transition after Birth: A 2-Center Randomized Controlled Pilot Feasibility Trial. J Pediatr. 2016 Mar;170:73-8.e1-4. doi: 10.1016/j.jpeds.2015.11.053. Epub 2015 Dec 30. |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| D010092 | Oximetry |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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|
| Pulse-oximetry | Device | 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. |
|
| Neurodevelopmental outcome | General movements | 16 weeks |
| Edmonton |
| Alberta |
| Canada |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D001784 | Blood Gas Analysis |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |