HealthyNCT00533715
Forced Inspiratory Flow Volume Curve in Healthy Young Children
An observational study of Healthy, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Spirometry testing should include both expiratory and inspiratory measurements as it may influence the expiratory flow volume curve indices. The ability to inhale medication may by judged by inspiratory flows. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 157 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2003to Oct 2005
- 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 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy children between 3-6 years old
Who cannot join
- Past or present respiratory lung disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
The Edmond and Lily Safra Children's Hospital, Sheba Medical Center
Ramat Gan, 52621
About this study
Spirometry testing should include both expiratory and inspiratory measurements as it may influence the expiratory flow volume curve indices. The ability to inhale medication may by judged by inspiratory flows. However, the inspiratory portion of the forced flow/volume maneuver in young healthy children has not yet been described.Objectives: To document and analyze the forced inspiratory flow volume curve indices in healthy young children.
Settings: Community kindergartens around Israel. participants; Healthy preschool children (age 2.5-6.5 years).
Read more
Methods: The teaching method included multi-target, interactive spirometry games (SpiroGame®) and accessory games for inspiration (e.g. inspiratory whistle).
Results: One hundred and fourteen of 157 children performed duplicate full adequate inspiratory maneuvers. Repeatability between two maneuvers was 5.6%, 4.0%, 5.1%, 7.3% for inspiratory capacity (IVC), forced inspiratory capacity (FIVC), peak inspiratory capacity (PIF), and mid inspiratory flow (MIF50), respectively. Inspiratory flow indices were significantly lower than the parallel expiratory flow indices and the time to reach PIF was significantly slower than the time to reach peak expiratory flow (meanSD; 22921ms vs. 92 8ms; p<0.0001). The shape of the inspiratory curve was parabolic and did not change with age. Predicted equations that were formed were in agreement with the extrapolated prediction equation values of older children.
We found that the majority of healthy young children can produce reliable inspiratory curves. Our results provide a framework for reference equations for inspiratory flow volume curve in the young ages. The clinical applications of these equations are yet to be explored.
Read the detailed description
Study protocol: The study included healthy children (according to questionnaire) in their early childhood. Any children with previous symptoms or present treatment for asthma, respiratory symptoms (cough, post nasal drip, pneumonia, rhinitis) other respiratory diseases were excluded from the study. Forced maneuvers were measured with a commercial spirometer, ZAN100 (ZAN Messgerate, Oberthulba, Germany). The spirometer software included online analysis of inspiratory and expiratory maneuvers. The curves were monitored on the computer screen to ensure best effort. The software also included an incentive-guided spirometry game. Inspiratory indices were not part of the games, therefore efforts were continued until the child could not pass the former inspiratory attempt any further. Healthy children performed the tests in a designated room in the kindergarten. Tests were performed in a standing position without a nose-clip. Maneuvers were repeated to obtain best possible efforts on at least three technically acceptable maneuvers. Technically acceptable curves were stored and the three consecutive curves with the maximal inspiratory maneuvers were analyzed for the study.
- Conditions
- Healthy
- Keywords
- Inspiratory Spirometry; Preschool Children; Computer games, Health
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 |
|---|---|---|
| >100 | The study included healthy children (2.5-6.5 years old) from a number of public kindergartens. An initial screening questionnaire based on the ATA-DLD-78-A for adults, adapted for children and translated into Hebrew, concerning the child's birth, past and present health status, was completed by the parents. Exclusion criteria: Previous symptoms or treatment for asthma, current respiratory symptoms or other present respiratory diseases. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2007 (estimated)
- Study startJan 2003
- Study completionOct 2005
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.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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
- Time perspective
- Other
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Barak Asher, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00533715
- Sponsor's protocol ID
- SHEBA-03-2303-BA-CTIL
- Status last verified
- Sep 2007
- First submitted
- 19 Sep 2007
- Last updated
- 21 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forced Inspiratory Flow Volume Curve in Healthy Young Children
- ClinicalTrials.gov ID
- NCT00533715
- Acronym / sponsor ID
- SHEBA-03-2303-BA-CTIL
- Conditions
- Healthy
- Keywords
- Inspiratory Spirometry; Preschool Children; Computer games, Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2003
- Study completion
- Oct 2005 (actual)
- First posted
- 21 Sep 2007 (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.
Spirometry testing should include both expiratory and inspiratory measurements as it may influence the expiratory flow volume curve indices. The ability to inhale medication may by judged by inspiratory flows. However, the inspiratory portion of the forced flow/volume maneuver in young healthy children has not yet been described.Objectives: To document and analyze the forced inspiratory flow volume curve indices in healthy young children.
Settings: Community kindergartens around Israel. participants; Healthy preschool children (age 2.5-6.5 years).
Methods: The teaching method included multi-target, interactive spirometry games (SpiroGame®) and accessory games for inspiration (e.g. inspiratory whistle).
Results: One hundred and fourteen of 157 children performed duplicate full adequate inspiratory maneuvers. Repeatability between two maneuvers was 5.6%, 4.0%, 5.1%, 7.3% for inspiratory capacity (IVC), forced inspiratory capacity (FIVC), peak inspiratory capacity (PIF), and mid inspiratory flow (MIF50), respectively. Inspiratory flow indices were significantly lower than the parallel expiratory flow indices and the time to reach PIF was significantly slower than the time to reach peak expiratory flow (meanSD; 22921ms vs. 92 8ms; p<0.0001). The shape of the inspiratory curve was parabolic and did not change with age. Predicted equations that were formed were in agreement with the extrapolated prediction equation values of older children.
We found that the majority of healthy young children can produce reliable inspiratory curves. Our results provide a framework for reference equations for inspiratory flow volume curve in the young ages. The clinical applications of these equations are yet to be explored.
Detailed description
Study protocol: The study included healthy children (according to questionnaire) in their early childhood. Any children with previous symptoms or present treatment for asthma, respiratory symptoms (cough, post nasal drip, pneumonia, rhinitis) other respiratory diseases were excluded from the study. Forced maneuvers were measured with a commercial spirometer, ZAN100 (ZAN Messgerate, Oberthulba, Germany). The spirometer software included online analysis of inspiratory and expiratory maneuvers. The curves were monitored on the computer screen to ensure best effort. The software also included an incentive-guided spirometry game. Inspiratory indices were not part of the games, therefore efforts were continued until the child could not pass the former inspiratory attempt any further. Healthy children performed the tests in a designated room in the kindergarten. Tests were performed in a standing position without a nose-clip. Maneuvers were repeated to obtain best possible efforts on at least three technically acceptable maneuvers. Technically acceptable curves were stored and the three consecutive curves with the maximal inspiratory maneuvers were analyzed for the study.
Study design
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| >100 | – | –The study included healthy children (2.5-6.5 years old) from a number of public kindergartens. An initial screening questionnaire based on the ATA-DLD-78-A for adults, adapted for children and translated into Hebrew, concerning the child's birth, past and present health status, was completed by the parents. Exclusion criteria: Previous symptoms or treatment for asthma, current respiratory symptoms or other present respiratory diseases. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy children between 3-6 years old
Key exclusion criteria (1 listed)
- Past or present respiratory lung disease
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 21 Sep 2007.
- Vilozni D, et al. The role of computer games in measuring spirometry in healthy and "asthmatic" preschool children. Chest. 2005 Sep;128(3):1146-55.Link provided by the sponsor.
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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.
Barak Asher, MD principal investigator
Sheba Medical Center
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 Sheba Medical Center at 1 site in Israel.
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 1 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 21 Sep 2007. 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 Israel. 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 21 Sep 2007.