Trial document





This trial has been registered retrospectively.
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  DRKS00004424

Trial Description

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Title

Lung function and airway hyper reactivity in late preterm and term infants after severe RSV infection in comparison to healthy controls

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

lung function in infants can be influenced i.e. by viral respiratory infection or prematurity. We therefore examin lung function in infants with and without prematurity and with and without respiratory infections

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Brief Summary in Scientific Language

Respiratory syncytial virus (RSV) is the most common agent causing upper and lower airway tract infection in infants. Nearly all children are infected at least once by RSV at the age of two years and about every 50th child has to be hospitalised during the course of disease. Besides acute symptoms like cough, wheezing and dyspnoe, RSV is supposed to cause long acting sequels like chronic cough and airway hyper reactivity. The results of this study might have important implications for therapy and prophylaxis of RSV infection. For example, it might help to identify children at highest risk to develop impaired lung function after RSV infection and thus enable a more specific prophylaxis of the disease by passive immunisation (palivizumab). Besides we will gain data about the lung growth in preterm and term children in early infancy. These data can be used in counselling parents about the expected lung development in their child

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Organizational Data

  •   DRKS00004424
  •   2013/12/20
  •   [---]*
  •   yes
  •   Approved
  •   324/12, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   J12.1 -  Respiratory syncytial virus pneumonia
  •   P07.2 -  Extreme immaturity
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Interventions/Observational Groups

  •   preterm and term infants without lower respiratory tract infection, baby lung function; FEF (0.75)
  •   term and preterm infants with lower respiratory tract infection, baby lung function testing, FEF (0.75)
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Forced expiratory flow (0.75) at one year of age

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Secondary Outcome

forced expiratory flow (0.75) in term an preterm infants

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2012/10/15
  •   39
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   0   Months
  •   12   Months
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Additional Inclusion Criteria

for RSV group:
positive RSV-test (ELISA/ PCR in nasopharyngeal aspirate) plus any of the follwing
- wheezing
- tachypnoea > 95. percentile of age
- prolonged expiratory phase or crackles on auscultation
- cyanosis (SpO2 < 92% without oxygen)

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Exclusion Criteria

- congenital heart defect
- pre-existing lung disease
- immune deficiency
- obvious skeletal thoracic malformation

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Addresses

  • start of 1:1-Block address primary-sponsor
    • ZKJ, Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. med  Marcus  Krüger 
    • Mathildenstrasse 1
    • 79106  Freiburg
    • Germany
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    • ZKJ, Universitätsklinikum Freiburg
    • Ms.  Prof. Dr. med  Andrea  Heinzmann 
    • Mathildenstrasse 1
    • 79106  Freiburg
    • Germany
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  • start of 1:1-Block address scientific-contact
    • ZKJ, Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. med  Marcus  Krüger 
    • Mathildenstrasse 1
    • 79106  Freiburg
    • Germany
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    • ZKJ, Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. med  Marcus  Krüger 
    • Mathildenstrasse 1
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • AbbVie Deutschland GmbH & Co.KGMedical Affairs DepartmentMax-Planck-Ring 2a65205 Wiesbaden
    • Max-Planck-Ring 2a
    • 65105  Wiesbaden
    • Germany
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    • ZKJ, Universitätsklinikum Freiburg
    • Mr.  Prof. Dr. med  Marcus  Krüger 
    • Mathildenstrasse 1
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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