Predicting Cerebral Palsy in Infants With White Matter Injury Using MRI

NCT ID: NCT06575283

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Palsy Periventricular White Matter Abnormalities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No intervention will be performed in this cohort study

Intervention Type 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.

Interventions

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No 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.

Intervention Type OTHER

Eligibility Criteria

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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

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

6 Months

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Shenzhen Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Zunyi Medical College

OTHER

Sponsor Role collaborator

Wuxi Women's & Children's Hospital

OTHER

Sponsor Role collaborator

Shanxi Provincial Maternity and Children's Hospital

OTHER

Sponsor Role collaborator

Chengdu Medical College

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Xinjiang Medical University

OTHER

Sponsor Role collaborator

Baoji Central Hospital

OTHER

Sponsor Role collaborator

Xian Children's Hospital

OTHER_GOV

Sponsor Role collaborator

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role collaborator

Third Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian Yang, Ph.D.,M.D

Role: STUDY_DIRECTOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status

Countries

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China

Central Contacts

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Yitong Bian, MD

Role: CONTACT

15209220323

Facility Contacts

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Jian Yang, Ph.D.,M.D.

Role: primary

0086-18991232396

Other Identifiers

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XJTU1AF2024LSYY-154

Identifier Type: -

Identifier Source: org_study_id

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