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

Primary Purpose

Respiratory Distress Syndrome, Newborn, Respiratory Failure

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Poractant alfa instillation
Beractant instillation
Sponsored by
Poznan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome, Newborn focused on measuring Brain oxygenation, NIRS, aEEG, surfactant

Eligibility Criteria

15 Minutes - 2 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 26-30 gestational age
  • surfactant instillation

Exclusion Criteria:

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

Sites / Locations

  • Department of Neonatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Poractant goup

Beractant group

Arm Description

Newborns, who will be monitored by amplitude integrated electroencephalography (aEEG) and near infrared spectroscopy (NIRS) during poractant instillation.

Newborns who will be monitored by aEEG and NIRS during beractant instillation

Outcomes

Primary Outcome Measures

Cerebral oxygenation
Cerebral tissue oxygenation measured with near-infrared spectroscopy
Brain bioelectrical activity
Brain bioelectrical activity measured with amplitude-integrated electroencephalography (aEEG)

Secondary Outcome Measures

Full Information

First Posted
June 19, 2013
Last Updated
March 2, 2020
Sponsor
Poznan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01941524
Brief Title
Brain Oxygenation and Function of Preterm Newborns During Administration of Two Different Surfactant Preparations
Official Title
Assessment of the Cerebral Tissue Oxygenation and the Bioelectrical Brain Activity of Preterm Newborns During Administration of Two Different Surfactant
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
March 3, 2013 (undefined)
Primary Completion Date
June 20, 2015 (Actual)
Study Completion Date
June 20, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poznan University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Newborn, Respiratory Failure
Keywords
Brain oxygenation, NIRS, aEEG, surfactant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Poractant goup
Arm Type
Active Comparator
Arm Description
Newborns, who will be monitored by amplitude integrated electroencephalography (aEEG) and near infrared spectroscopy (NIRS) during poractant instillation.
Arm Title
Beractant group
Arm Type
Active Comparator
Arm Description
Newborns who will be monitored by aEEG and NIRS during beractant instillation
Intervention Type
Drug
Intervention Name(s)
Poractant alfa instillation
Intervention Description
aEEG and NIRS monitoring during poractant alfa instilation
Intervention Type
Drug
Intervention Name(s)
Beractant instillation
Intervention Description
aEEG and NRs monitoring during beractant instillation
Primary Outcome Measure Information:
Title
Cerebral oxygenation
Description
Cerebral tissue oxygenation measured with near-infrared spectroscopy
Time Frame
4 hours after surfactant instillation
Title
Brain bioelectrical activity
Description
Brain bioelectrical activity measured with amplitude-integrated electroencephalography (aEEG)
Time Frame
4 hours after surfactant instillation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Minutes
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 26-30 gestational age surfactant instillation Exclusion Criteria: congenital heart disease congenital central nervous disorder congenital genetic disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Szczapa, M.D.
Organizational Affiliation
Poznan University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Department of Neonatology
City
Poznan
State/Province
Great Poland
ZIP/Postal Code
60-535
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

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