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

March 2, 2020 updated by: Tomasz Szczapa, Poznan University of Medical Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Great Poland
      • Poznan, Great Poland, Poland, 60-535
        • Department of Neonatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 minutes to 2 days (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 26-30 gestational age
  • surfactant instillation

Exclusion Criteria:

  • congenital heart disease
  • congenital central nervous disorder
  • congenital genetic disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Poractant goup
Newborns, who will be monitored by amplitude integrated electroencephalography (aEEG) and near infrared spectroscopy (NIRS) during poractant instillation.
Drug: Poractant alfa instillation
aEEG and NIRS monitoring during poractant alfa instilation
Active Comparator: Beractant group
Newborns who will be monitored by aEEG and NIRS during beractant instillation
Drug: Beractant instillation
aEEG and NRs monitoring during beractant instillation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral oxygenation
Time Frame: 4 hours after surfactant instillation
Cerebral tissue oxygenation measured with near-infrared spectroscopy
4 hours after surfactant instillation
Brain bioelectrical activity
Time Frame: 4 hours after surfactant instillation
Brain bioelectrical activity measured with amplitude-integrated electroencephalography (aEEG)
4 hours after surfactant instillation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poznan University of Medical Sciences

Investigators

  • Study Director: Tomasz Szczapa, M.D., Poznan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 3, 2013

Primary Completion (Actual)

June 20, 2015

Study Completion (Actual)

June 20, 2015

Study Registration Dates

First Submitted

June 19, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Actual)

March 5, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502-14-02215338-09873

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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