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

June 15, 2017 updated by: Carlos Alberto Longui, Faculdade de Ciências Médicas da Santa Casa de São Paulo

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

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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 01221-020
        • Recruiting
        • Santa Casa SP - School of Medical Sciences
        • Contact:

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

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

normal control school students

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone age determination by ultrasound (BAUS)
Time Frame: chronological ages between 6 and 16 years of age
Determination of bone age in years by employing a ultrasound device
chronological ages between 6 and 16 years of age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Faculdade de Ciências Médicas da Santa Casa de São Paulo

Investigators

  • Principal Investigator: Carlos A Longui, MD; PhD, Full Professor. Head of Pediatric Endocrinology Unit

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)

October 13, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 15, 2017

First Posted (Actual)

June 16, 2017

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 53659316.3.0000.5479

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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