Ulna Length in Otherwise Healthy Children (With the Exception of Mild to Moderate Asthma)ULNOIRNCT04062422
Ulna Length in Black Children
An observational study of Ulna Length in Otherwise Healthy Children (With the Exception of Mild to Moderate Asthma), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ulna Length in Otherwise Healthy Children (With the Exception of Mild to Moderate Asthma)
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 16 Apr 2018to 28 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: child between 3 to 18 years old, two parents of sub-saharian or caribbean origin, referred for asthma suspicion or follow-up
Who may be able to join
- age: 3 to 18 years old, two parents of sub-saharian or caribbean origin, referred for asthma suspicion or follow-up.
Who cannot join
- chronic disease excepting asthma, prematurity (<36 GW), steroid (>3/year), high dosage of inhaled steroid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Keywords
- ulna; healthy children; height predicted
What is being measured
The primary outcome is the main question the study is designed to answer.
Ulna length
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start16 Apr 2018
- Primary completion28 Mar 2019
- Study completion28 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulna Length in Otherwise Healthy Children (With the Exception of Mild to Moderate Asthma)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe Delclaux, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062422
- Sponsor's protocol ID
- N°IDRCB 2017-A02962-51
- Acronym
- ULNOIR
- Status last verified
- Aug 2019
- First submitted
- 19 Aug 2019
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35567383
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Childhood Pulmonary Function Using Ulna Length in Children of Sub-saharian or Caribbean Ethnicity
- ClinicalTrials.gov ID
- NCT04062422
- Acronym / sponsor ID
- ULNOIR / N°IDRCB 2017-A02962-51
- Keywords
- ulna; healthy children; height predicted
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 28 Mar 2019 (actual)
- Study completion
- 28 Apr 2019 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- child between 3 to 18 years old, two parents of sub-saharian or caribbean origin, referred for asthma suspicion or follow-up
Key inclusion criteria (1 listed)
- age: 3 to 18 years old, two parents of sub-saharian or caribbean origin, referred for asthma suspicion or follow-up.
Key exclusion criteria (1 listed)
- chronic disease excepting asthma, prematurity (<36 GW), steroid (>3/year), high dosage of inhaled steroid
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ulna length
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Results publication: PubMed 35567383Beydon 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Delclaux, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulna Length in Otherwise Healthy Children (With the Exception of Mild to Moderate Asthma), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulna length (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04062422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.