An interventional study of NIRS visible and predefined interventions and NIRS not visible and treatment as usual in Hypotension, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged Up to 6 Hours. Per ClinicalTrials.gov, last updated 2017-01-18.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Prevention
Objectives Firstly to examine in preterm neonates, whether it is possible to reduce number of hypotensive episodes and use of catecholamines by applying cerebral/peripheral near infrared spectroscopy in combination with predefined interventions and secondly to explore the potential impact on cerebral injury and mortality.
Hypothesis By using predefined interventions for changes in cerebral/peripheral oxygenation ratio investigators will reduce hypotensive episodes and use of catecholamines which will reduce cerebral injury and mortality.
Methods Cerebral (cTOI) and peripheral-muscle (pTOI) tissue-oxygenation-index (NIRO 300) will be measured for 24h starting \<6 hours postpartum. When cTOI/pTOI ratio increases >5% within a 6h period, predefined interventions will be performed.
Primary outcome parameter will be duration of hypotensive episodes and use of catecholamines during the first 48h after birth. Secondary outcome parameters will be cerebral injury and mortality.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 98 is above the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →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:
NIRS measurements are visible and the patients will be treated according to predefined clinical interventions: If cTOI/pTOI ratio increases \>5% within a six-hours-period echocardiography will be performed and based on results of echocardiography and blood pressure a volume bolus or, if ventilated, modification of ventilation or treatment of patent ductus arteriosus will be considered.
Device: NIRS visible and predefined interventions
NIRS measurements are not visible and the patients will be treated according to routine ('treatment as usual')
Device: NIRS not visible and treatment as usual
NIRS measurements are visible and the patients will be treated according to predefined clinical interventions: If cTOI/pTOI ratio increases \>5% within a six-hours-period echocardiography will be performed and based on results of echocardiography and blood pressure a volume bolus or, if ventilated, modification of ventilation or treatment of patent ductus arteriosus will be considered.
NIRS not visible and the patients will be treated according to routine
Time (percentage of hours) of hypotension/use of catecholamines during the first 48 hours
Time frame: 48 hours
Cerebral injury by cerebral ultrasound
From date of randomization until the date of discharge or date of 40 weeks of gestational age, whichever came first, assessed up to 16 weeks.
Time frame: up to 16 weeks
Mortality
Time frame: up to 16 weeks
Neonatal morbidities
From date of randomization until the date of discharge or date of 40 weeks of gestational age, whichever came first, assessed up to 16 weeks.
Time frame: up to 16 weeks
Heart rate
Time frame: 48 hours
Blood pressure
Time frame: 48 hours
Arterial oxygen saturation
Time frame: 48 hours
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Medical University of Graz