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NCT01941524 Clinical Trial

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

Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01941524
Other study ID # 502-14-02215338-09873
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 3, 2013
Est. completion date June 20, 2015

Study information
Verified date March 2020
Source Poznan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date June 20, 2015
Est. primary completion date June 20, 2015
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Days
Eligibility Inclusion Criteria:

- 26-30 gestational age

- surfactant instillation

Exclusion Criteria:

- congenital heart disease

- congenital central nervous disorder

- congenital genetic disorders

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Poractant alfa instillation
aEEG and NIRS monitoring during poractant alfa instilation
• Beractant instillation
aEEG and NRs monitoring during beractant instillation

Locations
Country Name City State
Poland Department of Neonatology Poznan Great Poland

Sponsors (1)
Lead Sponsor Collaborator
Poznan University of Medical Sciences

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cerebral oxygenation Cerebral tissue oxygenation measured with near-infrared spectroscopy 4 hours after surfactant instillation
Primary Brain bioelectrical activity Brain bioelectrical activity measured with amplitude-integrated electroencephalography (aEEG) 4 hours after surfactant instillation
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