Assessment of the Cerebral Tissue Oxygenation and the Bioelectrical Brain Activity of Preterm Newborns During Administration of Two Different Surfactant
Overview
- Phase
- Phase 4
- Intervention
- Poractant alfa instillation
- Conditions
- Respiratory Distress Syndrome, Newborn
- Sponsor
- Poznan University of Medical Sciences
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Cerebral oxygenation
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Tomasz Szczapa
doctor of medical science
Poznan University of Medical Sciences
Eligibility Criteria
Inclusion Criteria
- •26-30 gestational age
- •surfactant instillation
Exclusion Criteria
- •congenital heart disease
- •congenital central nervous disorder
- •congenital genetic disorders
Arms & Interventions
Poractant goup
Newborns, who will be monitored by amplitude integrated electroencephalography (aEEG) and near infrared spectroscopy (NIRS) during poractant instillation.
Intervention: Poractant alfa instillation
Beractant group
Newborns who will be monitored by aEEG and NIRS during beractant instillation
Intervention: Beractant instillation
Outcomes
Primary Outcomes
Cerebral oxygenation
Time Frame: 4 hours after surfactant instillation
Cerebral tissue oxygenation measured with near-infrared spectroscopy
Brain bioelectrical activity
Time Frame: 4 hours after surfactant instillation
Brain bioelectrical activity measured with amplitude-integrated electroencephalography (aEEG)