- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04062422
Ulna Length in Black Children (ULNOIR)
February 3, 2023 updated by: Assistance Publique - Hôpitaux de Paris
Prediction of Childhood Pulmonary Function Using Ulna Length in Children of Sub-saharian or Caribbean Ethnicity
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.
Study Overview
Status
Completed
Detailed 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)
Study Type
Observational
Enrollment (Actual)
350
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Paris, France, 75019
- Robert Debré Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
child between 3 to 18 years old, two parents of sub-saharian or caribbean origin, referred for asthma suspicion or follow-up
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Ulna length
Time Frame: 12 hours
|
12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christophe Delclaux, PhD, APHP
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 16, 2018
Primary Completion (ACTUAL)
March 28, 2019
Study Completion (ACTUAL)
April 28, 2019
Study Registration Dates
First Submitted
August 19, 2019
First Submitted That Met QC Criteria
August 19, 2019
First Posted (ACTUAL)
August 20, 2019
Study Record Updates
Last Update Posted (ACTUAL)
February 6, 2023
Last Update Submitted That Met QC Criteria
February 3, 2023
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- N°IDRCB 2017-A02962-51
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.