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Not yet recruitingNCT06575283Updated Sep 19, 2024

Predicting Cerebral Palsy in Infants With White Matter Injury Using MRI

An observational study in Cerebral Palsy and Periventricular White Matter Abnormalities, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Not yet recruiting at 1 site in China. Open to participants aged 6 Months to 2 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
6 Months to 2 Years
Sex
All
01

Study 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.

Read the detailed description

Cerebral palsy (CP) is a common group of movement disorders that often results in disability in children. In the context of CP, the importance of early diagnosis is crucial, but current diagnostic modalities often identify cases after the age of 2 years. After initial screening of infants at high risk for CP by behavioral scoring, magnetic resonance imaging (MRI) forms an integral part of the comprehensive evaluation. The training of conventional model of CP risk prediction requires a large investment of time and financial resources. The average sensitivity rate drops to 90%. Up to now, deep learning technology has been widely used in tasks related to image-based disease classification and has shown excellent performance.

Periventricular white matter injury (PVWMI) accounts for the largest proportion of various types of brain injuries in cerebral palsy, and the types of brain injuries in cerebral palsy are rich and complex, posing difficulties and challenges to deep learning models. Therefore, this study focuses on PVWMI, the most common type of cerebral palsy, and uses conventional MRI to develop a deep learning prediction model for CP in infants aged 6 months to 2 years old.

02

Conditions studied

  • Cerebral Palsy
  • Periventricular White Matter Abnormalities

Keywords

  • Cerebral palsy
  • Periventricular white matter injury
  • MRI
  • Deep learning
03

In context

Paralysis

750 studies on the registry are indexed under Paralysis; 133 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 60 across 199 observational studies indexed under Paralysis.

Browse Paralysis studies →

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 2 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

  1. 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);
  2. Those who underwent MRI at 6 months of age-2 years, including at least T1WI and T2WI sequences;
  3. 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).

Exclusion criteria

Exclusion Criteria:

  1. Incomplete MRI images or unreadable images due to motion artefacts;
  2. Incomplete neurobehavioural assessment data (including: gross motor function).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNo intervention will be performed in this cohort study

    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.

06

What researchers measure

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.

    Time frame: From September 2024 to December 2025

07

Study locations

1 site
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi, China
08

References and documents

Individual participant data

Plan to share: Yes — The data will be available from the corresponding author upon reasonable request.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06575283
Lead sponsor
First Affiliated Hospital Xi'an Jiaotong University
Collaborators
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Shenzhen Children's Hospital, Zunyi Medical College, Wuxi Women's & Children's Hospital, Shanxi Provincial Maternity and Children's Hospital, Chengdu Medical College, First Affiliated Hospital of Xinjiang Medical University, Baoji Central Hospital, Xian Children's Hospital, Guangzhou Women and Children's Medical Center, Third Affiliated Hospital of Zhengzhou University, Henan Provincial People's Hospital
Responsible party
Sponsor
First posted
Aug 28, 2024
Start date
Sep 1, 2024 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Sep 19, 2024

Study contacts

Yitong Bian, MD
Contact
bianyt0323@163.com
15209220323
Jian Yang, Ph.D.,M.D
study director · First Affiliated Hospital Xi'an Jiaotong University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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