A Phase 1/2 interventional study of Near Infrared Spectroscopy and Pulse-oximetry in Oxygen Saturation, sponsored by Medical University of Graz. Completed at 2 sites in 2 countries. Open to participants aged Up to 15 Minutes. Per ClinicalTrials.gov, last updated 2015-04-17.
Sponsored by Medical University of Graz · Phase 1/2, Interventional, and Treatment
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.
Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Device: Near Infrared Spectroscopy
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
Device: Pulse-oximetry
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.
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.
Cerebral tissue oxygen saturation (crSO2)
Duration in % minute of crSO2 \<10th or \>90th centile
Time frame: 15 minutes
Mortality
Rate of mortality
Time frame: 16 weeks
Cerebral injury
Cerebral injury assessed by sonography
Time frame: 16 weeks
Neurodevelopmental outcome
General movements
Time frame: 16 weeks
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
Time frame: 16 weeks
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of Graz