Brain White Matter Injury in Late Preterm Infants

August 8, 2020 updated by: Dan Chen, Shengjing Hospital

A Cohort Study on the Etiology and Pathological Types of Brain White Matter Injury in Late Preterm Infants

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).

Study Overview

Status

Unknown

Conditions

Detailed Description

1.1Patients Late preterm infants who were hospitalized in Shengjing Hospital from 1st January 2009 to 31st December 2022.

Risk factors prompting MRI evaluation included: (1) premature rupture of fetal membrane, intrauterine distress or placental abruption before delivery; (2) asphyxia, resuscitation and rescue history, circulatory dysfunction and infection during or after delivery; and (3) early convulsions.

1.2 Assessment of brain injury MRI scans were analyzed by a radiologist and a newborn pediatrician who were unfamiliar with the clinical history. WMI diagnosis was carried out as described by reference, with some improvements.

1.3 Collection of clinical data Data, including delivery by cesarean section, gestational hypertension, diabetes mellitus, premature rupture of membranes and placental abruption, were collected for the mothers. Gestational age, weight, gender, whether small for gestational age, Apgar score, resuscitation history, circulatory disorders, early-onset sepsis, convulsions, and MRI data were collected for the newborns.

History of resuscitation and rescue refers to positive pressure ventilation, tracheal intubation, chest compression or epinephrine application during labor; circulatory disorders include at least two of the following indicators: prolonged capillary filling time, hypotension, oliguria, increased heart rate and increased liver.

1.4 Instrumentation MRI of the head was performed using an Intera Achieva 3.0T MRI system (Philips, Best, Netherlands). All infants were scanned by conventional MRI and diffusion-weighted imaging (DWI). Because of the retrospective study design, there are differences in imaging schemes, sequences and parameters measured.

Study Type

Observational

Enrollment (Anticipated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital Of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging evaluation of different types of white matter injury in late preterm infants
Time Frame: 2009.1-2022.12
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
Time Frame: 2009.1-2022.12
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
Time Frame: 2009.1-2022.12
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
Time Frame: 2009.1-2022.12
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Record of gestational age
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants，gestational age(weeks) of every late preterm infant will be recorded
2009.1-2022.12
Record of weight
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants，weight(g) of every late preterm infant will be recorded
2009.1-2022.12
Record of gender
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants， gender(male/female) of every late preterm infant will be recorded
2009.1-2022.12
Record of small for gestational age
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants，whether small for gestational age(yes/no) of every late preterm infant will be recorded
2009.1-2022.12
Record of apgar score
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants，Apgar score(1-10) of every late preterm infant will be recorded
2009.1-2022.12
Number of resuscitation history
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants，resuscitation history(yes/no) of every late preterm infant will be recorded.History of resuscitation and rescue refers to positive pressure ventilation, tracheal intubation, chest compression or epinephrine application during labor
2009.1-2022.12
Number of circulatory disorders
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants，circulatory disorders(yes/no) of every late preterm infant will be recorded.Circulatory disorders include at least two of the following indicators: prolonged capillary filling time, hypotension, oliguria, increased heart rate and increased liver.
2009.1-2022.12
Number of early-onset sepsis
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants，early-onset sepsis(yes/no) of every late preterm infant will be recorded
2009.1-2022.12
Number of convulsions
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants，convulsions(yes/no) of every late preterm infant will be recorded
2009.1-2022.12
Record of delivery by cesarean section
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants，delivery by cesarean section(yes/no) of every mother will be recorded
2009.1-2022.12
Number of gestational hypertension
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants，gestational hypertension(mmHg) of every mother will be recorded
2009.1-2022.12
Number of diabetes mellitus
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants，diabetes mellitus(yes/no) of every mother will be recorded
2009.1-2022.12
Number of premature rupture of membranes
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants，premature rupture of membranes(yes/no) of every mother will be recorded
2009.1-2022.12
Number of placental abruption
Time Frame: 2009.1-2022.12
To identify the high risk factors of brain white matter injury in late preterm infants，placental abruption(yes/no) of every mother will be recorded
2009.1-2022.12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengjing Hospital

Investigators

  • Study Director: Jian Mao, doctor, Shengjing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

August 3, 2020

First Submitted That Met QC Criteria

August 8, 2020

First Posted (Actual)

August 11, 2020

Study Record Updates

Last Update Posted (Actual)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 8, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DChen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Sharing the imaging results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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