Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06575283

Predicting Cerebral Palsy in Infants With White Matter Injury Using MRI

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

6 month–2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. Accuracy of the model predicting cerebral palsy

    Time frame: From September 2024 to December 2025

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yitong Bian, MD

CONTACT

[email protected]

15209220323

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Collaborators

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

Registry information

Official study title

Early Prediction of Cerebral Palsy by MRI in Infants With White Matter Injury: a Multicenter Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.