HealthyLUNOKID-StudieNCT00723619
Investigation of Lungfunction Normal Values in Children and Adolescent in Germany (Spirometry, Ultrasonic Pneumography and Exhaled NO)
An observational study of Healthy, run by Marien Hospital Wesel at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 2,007 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2007to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: children and adolescents from classes and kindergarten in the regions Wesel,Düsseldorf and Hannover
Who may be able to join
- All children from a selected classes, which have an informed consent and an answered questionnaire
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Marien Hospital Wesel gGmbH
Wesel, North Rhine-Westphalia, 46483
About this study
Official title: Investigation of Lungfunction Normal Values in Children and Adolescent in Germany
Synopsis: LUNOKID-Study
Investigation of Lung function Normal Values in Children and Adolescent in Germany
Read more
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.
Read the detailed description
For detailed description please contact:
forschungsinstitut1@marien-hospital-wesel.de
- Conditions
- Healthy
- Keywords
- asthma, spirometry, FENO, normal values for spirometry in childhood, normal values for FENO in childhood
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Children and adolescent from German schools in the region Wesel, Hannover and Düsseldorf, selected via special school lists |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startJun 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,007 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marien Hospital Wesel
- Sponsor type
- University, hospital or other
- Collaborators
- Hannover Medical School, Heinrich-Heine University, Duesseldorf
- Investigators
- Dietrich Berdel, Prof. Dr., Study chair, Marien Hospital Wesel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723619
- Sponsor's protocol ID
- 2007067
- Acronym
- LUNOKID-Studie
- Status last verified
- Jul 2008
- First submitted
- 25 Jul 2008
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Lungfunction Normal Values in Children and Adolescent in Germany
- ClinicalTrials.gov ID
- NCT00723619
- Acronym / sponsor ID
- LUNOKID-Studie / 2007067
- Conditions
- Healthy
- Keywords
- asthma, spirometry, FENO, normal values for spirometry in childhood, normal values for FENO in childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,007 participants (actual)
- Lead sponsor
- Marien Hospital WeselUniversity, hospital or other
- Collaborators
- Hannover Medical School, Heinrich-Heine University, Duesseldorf
- Study start
- Jun 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 29 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Children and adolescent from German schools in the region Wesel, Hannover and Düsseldorf, selected via special school lists |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- children and adolescents from classes and kindergarten in the regions Wesel,Düsseldorf and Hannover
Key inclusion criteria (1 listed)
- All children from a selected classes, which have an informed consent and an answered questionnaire
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dietrich Berdel, Prof. Dr. study chair
Marien Hospital Wesel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Marien Hospital Wesel at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2010.