Investigation of Lungfunction Normal Values in Children and Adolescent in Germany (Spirometry, Ultrasonic Pneumography and Exhaled NO)
Condition: Healthy
Study type: Observational

Summary: 
      Synopsis: LUNOKID-Study

      Investigation of Lung function Normal Values in Children and Adolescent in Germany

      For the diagnostic work-up of childhood airway diseases lungfunction measurements play an
      important role. As childhood represents a period of continuous development and growth, not
      only is body size and weight increasing and body composition changing with age, but also is
      the lung developing both in size and airway differentiation. Results from lung function
      measurements in children and adolescents have thus to be related to lung function data which
      have been determined in a normal healthy age-matched childhood population. The quality of the
      reference values is therefore crucial for the interpretation of lung function results.

      The reference values for children that are used today have been created between around the
      1970th or 1980th, although the development and body size of children in the last decades has
      considerably changed and accelerated.

      The aim of the LUNOKID study is to create new reference values for lung function measures in
      healthy children aged 4 to 18 years. Measurements will be performed in schools and
      "kindergartens" in 3 regions of Germany (Wesel, Düsseldorf, Hannover).

      A modified ISAAC questionnaire will be distributed to the parents to get information on the
      family´s and child´s health history with regard to atopy, airway diseases or other diseases
      that could influence the lung function results. A clinical examination on the day of lung
      function performance should exclude acute infections or other diseases. Parents will have to
      give informed consent to the study.

      Study personal, especially trained in the lung function unit of the University Hannover, is
      going to do all examination and lung function measures during the normal school hours at the
      sites of the schools and kindergartens.

      The following measurements will be performed according to the respective SOPs:

        -  Body weight and hight

        -  Exhaled NO, using the NIOX -MINO in children from the age of 5 years onwards, in 4 years
           old children using the off-line method (both Aerocrine)

        -  Spirometry including Flow volume curves (Parameter FEV1, FEV0.5, FEV 0.75, PEF, FVC, MEF
           25, MEF 50, MEF 75) using a Spirometer by the company ndd Medizintechnik AG, Zürich

        -  Ultrasonic pneumography (UPG) (tidal breathing), ndd Medizintechnik AG, Zürich

      It is planned to have 50 valid measurements per gender and age group. Considering that about
      50 % of the children (and 50-75% of the 4 years´old) have to be excluded for the "normal
      reference analysis" either for health reasons or because the lung function measurement cannot
      be correctly performed. The investigators therefore calculate to included in the study around
      3300 children.

      All data will be gathered and managed in a central database in the IUF in Düsseldorf. The
      statical analysis will include regression analyses to calculate the reference values.

      It is planned to have the new reference values included in the guidelines for diagnostic and
      management of asthma in childhood, and in the software of lung function equipment. By now,
      the study is approved by the Ethical Committee responsible for the PI in Wesel.
    

Detailed description: 
      For detailed description please contact:

      forschungsinstitut1@marien-hospital-wesel.de
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children and adolescents from classes and kindergarten in the regions Wesel,Düsseldorf and
        Hannover
      
Keywords: asthma; spirometry; FENO; normal values for spirometry in childhood; normal values for FENO in childhood