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

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ClinicalTrials.gov Identifier: NCT01941524
Recruitment Status : Unknown
Verified October 2013 by Tomasz Szczapa, Poznan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 13, 2013
Last Update Posted : October 21, 2013
Sponsor:
Information provided by (Responsible Party):
Tomasz Szczapa, Poznan University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Newborn Respiratory Failure Drug: Poractant alfa instillation Drug: Beractant instillation Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of the Cerebral Tissue Oxygenation and the Bioelectrical Brain Activity of Preterm Newborns During Administration of Two Different Surfactant
Study Start Date : September 2013
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : August 2014


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




Primary Outcome Measures :
  1. Bandwidth, lower and upper margin of amplitude integrated signal while using two different surfactant preparations (beractant and poractant. [ Time Frame: 12 hours after surfactant instillation ]

Secondary Outcome Measures :
  1. Comparison of brain oxygenation (rSO2) while using two different surfactant preparations (beractant and poractant). [ Time Frame: 12 hours after surfactant instillation ]

Other Outcome Measures:
  1. Differences in pulmonary function parameters while using two different surfactant preparations. [ Time Frame: 12 hours after surfactant instillation ]
    Expiratory tidal volume (Vte), minute ventilation(MV) and dynamic compliance are going to be measured.



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Ages Eligible for Study:   up to 2 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 26-30 gestational age
  • surfactant instillation

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941524


Contacts
Contact: Tomasz Szczapa, M.D. +48 607 576 457 tszczapa@gmail.com

Locations
Poland
Department of Neonatology Recruiting
Poznan, Great Poland, Poland, 60-535
Contact: Tomasz Szczapa, M.D.    +48 607 576 457    tszczapa@gmail.com   
Principal Investigator: Łukasz Karpiński, Physician         
Sponsors and Collaborators
Poznan University of Medical Sciences
Investigators
Study Director: Tomasz Szczapa, M.D. Poznan University of Medical Sciences

Responsible Party: Tomasz Szczapa, doctor of medical science, Poznan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01941524     History of Changes
Other Study ID Numbers: 502-14-02215338-09873
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: October 21, 2013
Last Verified: October 2013

Keywords provided by Tomasz Szczapa, Poznan University of Medical Sciences:
Brain oxygenation
NIRS
aEEG
surfactant

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pulmonary Surfactants
Poractant alfa
Beractant
Respiratory System Agents