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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Poractant goup | Active Comparator | Newborns, who will be monitored by amplitude integrated electroencephalography (aEEG) and near infrared spectroscopy (NIRS) during poractant instillation. |
|
| Beractant group | Active Comparator | Newborns who will be monitored by aEEG and NIRS during beractant instillation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Poractant alfa instillation | Drug | aEEG and NIRS monitoring during poractant alfa instilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral oxygenation | Cerebral tissue oxygenation measured with near-infrared spectroscopy | 4 hours after surfactant instillation |
| Brain bioelectrical activity | Brain bioelectrical activity measured with amplitude-integrated electroencephalography (aEEG) | 4 hours after surfactant instillation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomasz Szczapa, M.D. | Poznan University of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neonatology | Poznan | Great Poland | 60-535 | Poland |
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| Beractant instillation | Drug | aEEG and NRs monitoring during beractant instillation |
|
| ID | Term |
|---|---|
| D012127 | Respiratory Distress Syndrome, Newborn |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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