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Forced Inspiratory Flow Volume Curve in Healthy Young Children

Sponsor
Sheba Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00533715
Collaborator
(none)
157
Enrollment
1
Location
33
Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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. 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 (meanSD; 22921ms 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    157 participants
    Time Perspective:
    Other
    Official Title:
    Forced Inspiratory Flow Volume Curve in Healthy Young Children
    Study Start Date :
    Jan 1, 2003
    Actual Study Completion Date :
    Oct 1, 2005

    Arms and Interventions

    Arm Intervention/Treatment
    >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.

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      3 Years to 6 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      Yes
      Inclusion Criteria:
      • healthy children between 3-6 years old
      Exclusion Criteria:
      • Past or present respiratory lung disease

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 The Edmond and Lily Safra Children's Hospital, Sheba Medical Center Ramat-Gan Israel 52621

      Sponsors and Collaborators

      • Sheba Medical Center

      Investigators

      • Principal Investigator: Barak Asher, MD, Sheba Medical Center

      Study Documents (Full-Text)

      None provided.

      More Information

      Additional Information:

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00533715
      Other Study ID Numbers:
      • SHEBA-03-2303-BA-CTIL
      First Posted:
      Sep 21, 2007
      Last Update Posted:
      Sep 21, 2007
      Last Verified:
      Sep 1, 2007
      Keywords provided by , ,
      Inspiratory Spirometry; Preschool Children; Computer games
      Health
      Additional relevant MeSH terms:
      Respiratory Aspiration

      Study Results

      No Results Posted as of Sep 21, 2007