Forced Inspiratory Flow Volume Curve in Healthy Young Children

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00533715
First received: September 19, 2007
Last updated: September 20, 2007
Last verified: September 2007
  Purpose

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
Healthy

Study Type: Observational
Study Design: Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: Forced Inspiratory Flow Volume Curve in Healthy Young Children

Further study details as provided by Sheba Medical Center:

Enrollment: 157
Study Start Date: January 2003
Study Completion Date: October 2005
Groups/Cohorts
Control: >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.


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.

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy children between 3-6 years old

Exclusion Criteria:

  • Past or present respiratory lung disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00533715

Locations
Israel
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
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00533715     History of Changes
Other Study ID Numbers: SHEBA-03-2303-BA-CTIL
Study First Received: September 19, 2007
Last Updated: September 20, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Inspiratory Spirometry; Preschool Children; Computer games
Health

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014