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

Control, Population Clinical Trial

Official title:

Analyses of Bone Age Determined by Ultrasound in a Cohort of Brazilian Control Children and Adolescents: Comparison With Conventional Bone Age Determined by X-Ray

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03190109
• Other study ID #: 53659316.3.0000.5479
• Status: Recruiting
• Phase: N/A
• First received: June 12, 2017
• Last updated: June 15, 2017
• Start date: October 13, 2016
• Est. completion date: March 2018

Study information

• Verified date: June 2017
• Source: Faculdade de Ciências Médicas da Santa Casa de São Paulo
• Contact: Carlos A Longui, MD; PhD
• Phone: 55-11-983266815
• Email: carloslongui[@]msn.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Control, Population

Locations

Country	Name	City	State
Brazil	Santa Casa SP - School of Medical Sciences	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone age determination by ultrasound (BAUS)	Determination of bone age in years by employing a ultrasound device	chronological ages between 6 and 16 years of age