Forced Inspiratory Flow Volume Curve in Healthy Young Children

NCT00533715 | Completed

• 1 other identifier: SHEBA-03-2303-BA-CTIL
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Inspiratory Spirometry; Preschool Children; Computer games; Health

Study Arms (1)

>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.

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy children between 3-6 years old

You may not qualify if:

• Past or present respiratory lung disease

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

The Edmond and Lily Safra Children's Hospital, Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Related Links

• 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.

Study Officials

• Barak Asher, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 19, 2007
• First Posted: September 21, 2007
• Study Start: January 1, 2003
• Study Completion: October 1, 2005
• Last Updated: September 21, 2007

Record last verified: 2007-09

Locations

IL (1)