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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02637817
Other study ID # 2016YFC0100300
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2016
Est. completion date December 2019

Study information

Verified date June 2018
Source First Affiliated Hospital Xi'an Jiaotong University
Contact Jian Yang, Ph.D.,M.D.
Phone +8618991232396
Email cjr.yangjian@vip.163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

As a common white matter (WM) disease in preterm neonates, punctate white matter lesion (PWML) frequently leads to the abnormalities of brain development (e.g. the motor, visual and auditory disorders), even to cerebral palsy (CP) and amblyopia during childhood. However, it is lack of certain methods in identifying the prognosis of PWML. Through using various advanced MRI techniques, neuro-behavioral and visual assessments, a multicenter longitudinal study would be conducted to follow-up the PWML neonates with varying spatial-position and degree lesions. Through tracking the variations in WM microstructures from neonate period to childhood (2 years old and 3 years old), this study aims to explore (1) the potential relations between varying PWMLs and motor and visual disorders (2) the relations between WM MRI-metrics and neurodevelopmental assessment results, and thus determine the early biomarkers to identify CP and amblyopia.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility Inclusion Criteria:

-(1) Age: 1-28 days (2) PWML (3) High quality MRI scan

Exclusion Criteria:

-(1) Congenital malformations, infections, metabolic disorders, intraventricular hemorrhage (2) Neonates of mothers with gestational diabetes, hypertension, hypoglycemia and history of alcohol

Study Design


Locations

Country Name City State
China First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi

Sponsors (11)

Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University Baoji Central Hospital, Children's Hospital of Fudan University, General Hospital of Ningxia Medical University, Hainan People's Hospital, Second Affiliated Hospital of Wenzhou Medical University, Shaanxi Provincial People's Hospital, Shengjing Hospital, Shenzhen Children's Hospital, Xijing Hospital, Zunyi Medical College

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cerebral Palsy The enrolled subjects who will be diagnosed as cerebral palsy by clinical examination at age 2. At age 2
Secondary Amblyopia or movement disorder The enrolled subjects who will be diagnosed as amblyopia or movement disorder by clinical examination at age 3. At age 3
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