Bone Age Determined by Ultrasound (BAUS) in Brazilian Control Children

NCT ID: NCT03190109

Last Updated: 2017-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-13

Study Completion Date

2018-03-31

Brief Summary

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Aiming to validate the use of bone age determined by ultrasound (BAUS) in Brazilian children, normal control students will be studied. X-Ray bone age (RXBA) and BAUS will be determined in 500 children and adolescents of both genders, with chronological age varying from 6-16 years.

Concordance analysis and the correlation between both BA determination methods will be performed.

Detailed Description

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Bone age is a valuable method to recognize the maturation status of development and growth. Classical analyses is performed by using the Greulich and Pyle X-Ray measurement. Such analyses have some restrictions such as intra- and inter observer variability, and variable synchronicity of bone maturation.

Bone age determined by ultrasound (BAUS) has been indicated as a fast and reproducible method, allowing decimal BA determination and avoiding the need for X-Ray.

Our aim is to validate the BAUS method in Brazilian normal controls. School students of both genders, with age varying from 6 to 16 years will be included.

Conditions

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Control, Population

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* absence of chronic illness and drug ingestion

Exclusion Criteria

* any chronic disease or medicine use
* body mass index: \< -2SDS or \> +2SDS
* stature : \< -2SDS or \> +2SDS
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Faculdade de Ciências Médicas da Santa Casa de São Paulo

OTHER

Sponsor Role lead

Responsible Party

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Carlos Alberto Longui

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos A Longui, MD; PhD

Role: PRINCIPAL_INVESTIGATOR

Full Professor. Head of Pediatric Endocrinology Unit

Locations

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Santa Casa SP - School of Medical Sciences

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Carlos A Longui, MD; PhD

Role: CONTACT

55-11-983266815

Cristiane Kochi, MD

Role: CONTACT

55-11-983832747

Facility Contacts

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Cristiane Kochi, MD

Role: primary

55-11-983832747

Other Identifiers

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53659316.3.0000.5479

Identifier Type: -

Identifier Source: org_study_id

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