Predicting Cerebral Palsy in Infants With White Matter Injury Using MRI

NCT06575283 | Not Yet Recruiting

• 1 other identifier: XJTU1AF2024LSYY-154
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determin the MRI features associated with cerebral palsy and to develop prediction models of pediatric disorders by combining MRI with artificial intelligence. The main questions it aims to answer are:

• How to achieve features on conventional MRI associated with cerebral palsy?
• How to predict the risk of cerebral palsy in infants aged 6 to 2 years based on conventional MRI and deep learning? Researchers will compare characteristics of periventricular white matter injury with cerebral palsy to those without cerebral palsy. Participants will be asked to provide MRI data, clinical diagnoses information, and follow-up outcomes.

Conditions

Cerebral Palsy; Periventricular White Matter Abnormalities

Keywords

Cerebral palsy; Periventricular white matter injury; MRI; Deep learning

Outcome Measures

Primary Outcomes (1)

• Accuracy of the model predicting cerebral palsy

  Determine the accuracy of PVWMI classification and cerebral palsy prediction. The higher the value, the better the model performance.

  From September 2024 to December 2025

Study Arms (1)

PVWMI Infants aged 6 months to 2 years

Infants will be scanned by MRI at the age of 6 months to 2 years. The infants of periventricular white matter injury (PVWMI) will be enrolled.

Other: No intervention will be performed in this cohort study

Interventions

No intervention will be performed in this cohort study OTHER

Deep learning classification models will be used for automatic prediction of cerebral palsy. Machines will be used to assist doctors in cerebral palsy risk evaluation.

PVWMI Infants aged 6 months to 2 years

Eligibility Criteria

• Age: 6 Months - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This study will follow up infants from multiple regions and different hospitals who underwent MRI examinations between 6 months and 2 years old. Each infant and young child included T1-weighted imaging (T1WI) and T2-weighted imaging (T2WI). According to the follow-up outcomes, these infants will be divided into the following groups: cerebral palsy, other diagnoses that did not develop into cerebral palsy, or inability to confirm the diagnosis.

You may qualify if:

• Infants and children at high risk of periventricular white matter injury (PVWMI) (gestational age \<35 weeks, birth weight \<2.6 kg, forceps-assisted delivery/fetal head attraction, Apgar score \<7, hypoglycaemia, sepsis, electrolyte disturbances, premature rupture of membranes);
• Those who underwent MRI at 6 months of age-2 years, including at least T1WI and T2WI sequences;
• Upon follow-up, the patient's clinical diagnosis: cerebral palsy, other diagnoses that did not develop into cerebral palsy, or inability to confirm the diagnosis).

You may not qualify if:

• Incomplete MRI images or unreadable images due to motion artefacts;
• Incomplete neurobehavioural assessment data (including: gross motor function).

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator
• Shenzhen Children's Hospital: collaborator
• Zunyi Medical College: collaborator
• Wuxi Women's & Children's Hospital: collaborator
• Shanxi Provincial Maternity and Children's Hospital: collaborator
• Chengdu Medical College: collaborator
• First Affiliated Hospital of Xinjiang Medical University: collaborator
• Baoji Central Hospital: collaborator
• Xian Children's Hospital: collaborator
• Guangzhou Women and Children's Medical Center: collaborator
• Third Affiliated Hospital of Zhengzhou University: collaborator
• Henan Provincial People's Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jian Yang, Ph.D.,M.D

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Yitong Bian, MD

CONTACT

15209220323; bianyt0323@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: September 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be available after the paper published.
• Access Criteria: The data can be used just for research purpose. Users can contact to the corresponding author through e-mail.

Locations

CN (1)