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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04062422
Other study ID # N°IDRCB 2017-A02962-51
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 16, 2018
Est. completion date April 28, 2019

Study information

Verified date August 2019
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Height measurement is unreliable when neuromuscular weakness or spinal deformity is present. The aim of this study was to accurately predict pulmonary function from a limb segment (ulna) measurement that is precise and reproducible. Equations are available in caucasian children but are not available in children of sub-saharian or caribbean ethnicity, which was the aim of the study. To this end, 350 black children referred for pulmonary function testing for asthma follow-up will be included.


Description:

Ulna (dominant and non-dominant arm), height measurement in 350 asthmatic children of sub-saharian or caribbean ethnicity (both parents). Repeatability analysis (ulna and height) for the first fifty children. Recording of pulmonary function tests results (spirometry, resistance measurements)


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date April 28, 2019
Est. primary completion date March 28, 2019
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - age: 3 to 18 years old, two parents of sub-saharian or caribbean origin, referred for asthma suspicion or follow-up. Exclusion Criteria: - chronic disease excepting asthma, prematurity (<36 GW), steroid (>3/year), high dosage of inhaled steroid

Study Design


Related Conditions & MeSH terms

  • Ulna Length in Otherwise Healthy Children (With the Exception of Mild to Moderate Asthma)

Locations

Country Name City State
France Robert Debre Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Beydon N, Leye F, Bokov P, Delclaux C. Prediction of height using ulna length in African-Caribbean children. Pediatr Pulmonol. 2022 Sep;57(9):2032-2039. doi: 10.1002/ppul.25972. Epub 2022 May 21. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Ulna length 12 hours