Brain White Matter Injury in Late Preterm Infants

NCT04508517 | Unknown

• 1 other identifier: DChen
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

At 34 weeks, the brain weight of preterm infants is only 65% that of term infants, and the cortex volume is 53% that of term infants. Damage at this stage of development will also change the trajectory of specific processes in the development of neurons and glial cells, resulting in neurological dysfunction in survivors.The incidence of cerebral palsy in late preterm infants is three times higher than in term infants, and about 25% lag behind term infants in learning, language and other neurodevelopment. At 34-37 weeks of gestation, oligodendrocytes are still late oligodendrocyte precursors and vascular development of the white matter area is immature, making the brain more prone to white matter injury (WMI).

Conditions

White Matter Injury

Keywords

white matter injury;late preterm infants

Outcome Measures

Primary Outcomes (4)

• Imaging evaluation of different types of white matter injury in late preterm infants

  The number of participants of white matter injury in late preterm infants, number of late preterm infants with different degrees (mild, moderate, severe) white matter injury and the imaging and pathological characteristics of early white matter injury (within 2 weeks after birth) using T1WI,T2WI,DWI,SWI.

  2009.1-2022.12

• Imaging differentiation of hemorrhagic and non hemorrhagic injuries

  Using magnetic resonance technology, especially magnetic sensitivity, to identify and classify the cases of white matter injury in late preterm infants with or without hemorrhagic injury

  2009.1-2022.12

• Number of late preterm infants and distribution of gray matter injury in late preterm infants with white matter injury

  Using magnetic resonance technology, To determine the number of gray matter injuries (cortex, thalamus, basal ganglia, brainstem) in late preterm infants with white matter injury

  2009.1-2022.12

• The number and distribution of PVL like injury in white matter injury of late preterm infants

  Using magnetic resonance technology, to determine the probability of PVL-like injury in white matter injury of late preterm infants and which type and location are more prone to PVL-like outcomes

  2009.1-2022.12

Secondary Outcomes (14)

• Record of gestational age

  2009.1-2022.12

• Record of weight

  2009.1-2022.12

• Record of gender

  2009.1-2022.12

• Record of small for gestational age

  2009.1-2022.12

• Record of apgar score

  2009.1-2022.12

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Late preterm infants undergoing head MRI, who were hospitalized in Shengjing Hospital from 1st January 2009 to 31st December 2022, were enrolled in this study.

You may qualify if:

• MRI head examination with informed consent of guardian
• Age 34-36+6 weeks

You may not qualify if:

• Other encephalopathies or congenital abnormality of brain development except white matter injury were excluded

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

Related Publications (22)

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  PMID: 27257863 RESULT

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Study Officials

• Jian Mao, doctor

  Shengjing Hospital

  STUDY DIRECTOR

Central Study Contacts

Dan Chen, master

CONTACT

+8618940259088; youdrop@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending doctor，Principal Investigator

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 11, 2020
• Study Start: January 1, 2009
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)