NCT01941524

Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations

Assessment of the Cerebral Tissue Oxygenation and the Bioelectrical Brain Activity of Preterm Newborns During Administration of Two Different Surfactant

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Poznan University of Medical Sciences · Academic / Other
• Sex: All
• Age: 15 Minutes – 2 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome, Newborn
• Respiratory Failure

Interventions

Type	Name	Description
DRUG	Poractant alfa instillation	aEEG and NIRS monitoring during poractant alfa instilation
DRUG	Beractant instillation	aEEG and NRs monitoring during beractant instillation

Timeline

• Start date: 2013-03-03
• Primary completion: 2015-06-20
• Completion: 2015-06-20
• First posted: 2013-09-13
• Last updated: 2020-03-05

Locations

1 site across 1 country: Poland