Etiology of Motor Developmental Delay in Children

Delayed; Development, Intellectual Clinical Trial

— MDD  

Official title:

Etiology of Motor Developmental Delay in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03130972
• Other study ID #: BD2015-129
• Status: Completed
• Phase: N/A
• First received: November 15, 2016
• Last updated: April 24, 2017
• Start date: January 2009
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Bundang CHA Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to identify the etiology of children with motor developmental delay, in association with the results of magnetic resonance imaging and genetic analysis.

Description:

Results of other available assessments including Gross Motor Function Measurements and Bayley Scale of Infant Development, second edition, modified Ashworth Scale, IQ score and developmental language assessments are to be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1355
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• clinical diagnosis of motor developmental delay

• available results of functional assessments at ages older than 18 months Functional measures include either GMFM or BSID_II

Exclusion Criteria:

• single domain delay other than motor (e.g., speech delay)

Related Conditions & MeSH terms

• Delayed; Development, Intellectual
• Delayed;Development;Physical

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bundang CHA Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Gross Motor Function Classification System from baseline at 6 months	To avoid variation in each individual the exact date of evaluation for every outcome is included to estimate the exact time from birth	through study completion, an average of 1 year
Secondary	Brain MRI findings	the first brain MRI taken after the event causative to developmental delay, read by radiology specialists	From the date of the first documented developmental delay until the date of last documentation or date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Mental quotient	BSID-II mental month estimated/actual age in month times 100	From the date of the first documented developmental delay until the date of last documentation or date of death from any cause, whichever came first, assessed up to 100 months