A Phase 4 interventional study of Poractant alfa instillation and Beractant instillation in Respiratory Distress Syndrome, Newborn and Respiratory Failure, sponsored by Poznan University of Medical Sciences. Completed at 1 site in Poland. Open to participants aged 15 Minutes to 2 Days. Per ClinicalTrials.gov, last updated 2020-03-05.
Sponsored by Poznan University of Medical Sciences · Phase 4, Interventional, and Treatment
The purpose of the study is to determine whether there are differences in bioelectrical function (measured by amplitude integrated electroencephalography) and brain oxygenation (measured by near infrared spectroscopy) while and after instillation of two different surfactant preparations.
Patients randomized to one of the treatment groups: 1) SRT with porcine preparation - poractant alfa; 2) SRT with bovine preparation - beractant. Continuous monitoring and simultaneous recordeding of 1) saturation (SpO2) and heart rate (HR) measured with pulse oximetry, cerebral tissue oxygenation measured with near-infrared spectroscopy, amplitude-integrated electroencephalography.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 22 is below the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Poznan University of Medical Sciences is the lead sponsor of 143 studies on the registry; 46 are open to participants now.
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Exclusion Criteria:
Newborns, who will be monitored by amplitude integrated electroencephalography (aEEG) and near infrared spectroscopy (NIRS) during poractant instillation.
Drug: Poractant alfa instillation
Newborns who will be monitored by aEEG and NIRS during beractant instillation
Drug: Beractant instillation
aEEG and NIRS monitoring during poractant alfa instilation
aEEG and NRs monitoring during beractant instillation
Cerebral oxygenation
Cerebral tissue oxygenation measured with near-infrared spectroscopy
Time frame: 4 hours after surfactant instillation
Brain bioelectrical activity
Brain bioelectrical activity measured with amplitude-integrated electroencephalography (aEEG)
Time frame: 4 hours after surfactant instillation
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
Poznan University of Medical Sciences