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Clinical Trials/NCT04508517
NCT04508517
Unknown
Not Applicable

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

Shengjing Hospital1 site in 1 country3,000 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
White Matter Injury
Sponsor
Shengjing Hospital
Enrollment
3000
Locations
1
Primary Endpoint
Number of late preterm infants and distribution of gray matter injury in late preterm infants with white matter injury
Last Updated
5 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
December 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dan Chen

Attending doctor,Principal Investigator

Shengjing Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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.

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

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

Secondary Outcomes

  • Number of early-onset sepsis(2009.1-2022.12)
  • Record of small for gestational age(2009.1-2022.12)
  • Record of gestational age(2009.1-2022.12)
  • Record of gender(2009.1-2022.12)
  • Record of apgar score(2009.1-2022.12)
  • Number of circulatory disorders(2009.1-2022.12)
  • Number of convulsions(2009.1-2022.12)
  • Record of weight(2009.1-2022.12)
  • Number of resuscitation history(2009.1-2022.12)
  • Record of delivery by cesarean section(2009.1-2022.12)
  • Number of gestational hypertension(2009.1-2022.12)
  • Number of diabetes mellitus(2009.1-2022.12)
  • Number of premature rupture of membranes(2009.1-2022.12)
  • Number of placental abruption(2009.1-2022.12)

Study Sites (1)

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