AQUApay (AQUA Predictive Ability in Youths): Study on the Predictive Ability of the Questionnaire AQUA© in Children and Adolescents

NCT03823586 | Completed

• 1 other identifier: 01/2019
• Study Type: observational
• Target: 133
• Locations: 1 country
• Sites: 1

Brief Summary

Allergic diseases like asthma, rhinitis, conjunctivitis and dermatitis are very frequent in athletes, even if those complaining allergic symptoms do not always receive a medical diagnosis. Many athletes already start competitive sport activities in pediatric age, but allergy screening tests are usually not performed when assessing eligibility to sport practice. Therefore, the objective of the present study is assessing the predictive ability of the Allergy Questionnaire for Athletes (AQUA©), pediatric version, to predict the atopic status in young athletes.

Conditions

Young Athletes

Outcome Measures

Primary Outcomes (1)

• Atopic status

  Having at least 1 positive skin prick test to common aero-allergens

  Day 0

Secondary Outcomes (1)

• Psychological well-being

  Day 0

Study Arms (2)

Children

Diagnostic Test: Questionnaire AQUA©, pediatric version

Adolescents

Diagnostic Test: Questionnaire AQUA©, pediatric version

Interventions

Questionnaire AQUA©, pediatric version DIAGNOSTIC_TEST

A version of AQUA© recently adapted and pretested in young athletes. It is a self-administered questionnaire composed of 25 items includes items about type, duration and intensity of training sessions, allergic status, habits of children (supplements and drugs intake) and their parents (smoking), presence and burden of infections.

Adolescents; Children

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Athletes aged 7 to 14 years old, recruited from several sport associations located in the city of Palermo (Italy).

You may qualify if:

• \- Athletes, males or females, 7 to 14 years old

You may not qualify if:

• Use of systemic antihistamines or long term or high dose corticosteroids in the last two weeks;
• Poor understanding of written or spoken Italian;
• Lack of written informed consent.

Sponsors & Collaborators

• Istituto per la Ricerca e l'Innovazione Biomedica: lead

Study Sites (1)

Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council

Palermo, Sicily, 90146, Italy

Location

Related Publications (1)

• Fasola S, Ferrante G, Malizia V, Bommarito N, Del Giacco S, Bonini M, Baiardini I, Bellafiore M, La Grutta S. Validity and repeatability of the Pediatric Allergy Questionnaire for Athletes (AQUAped) for the screening of atopy. Pediatr Allergy Immunol. 2021 Apr;32(3):437-444. doi: 10.1111/pai.13410. Epub 2020 Dec 2.

  PMID: 33202069 DERIVED

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of the group "Clinical and Environmental Epidemiology of Pulmonary and Allergic Pediatric Diseases". Institute of Biomedicine and Molecular Immunology, IBIM, National Research Council of Palermo, Italy.

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: January 30, 2019
• Study Start: March 11, 2019
• Primary Completion: February 7, 2020
• Study Completion: February 7, 2020
• Last Updated: September 1, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)