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Brain White Matter Injury in Late Preterm Infants

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04508517
Enrollment
3000
Registered
2020-08-11
Start date
2009-01-31
Completion date
2022-12-31
Last updated
2020-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

White Matter Injury

Keywords

white matter injury;late preterm infants

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.

Interventions

None listed

Sponsors

Shengjing Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Imaging differentiation of hemorrhagic and non hemorrhagic injuries2009.1-2022.12Using 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
Imaging evaluation of different types of white matter injury in late preterm infants2009.1-2022.12The 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.
Number of late preterm infants and distribution of gray matter injury in late preterm infants with white matter injury2009.1-2022.12Using magnetic resonance technology, To determine the number of gray matter injuries (cortex, thalamus, basal ganglia, brainstem) in late preterm infants with white matter injury
The number and distribution of PVL like injury in white matter injury of late preterm infants2009.1-2022.12Using 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

MeasureTime frameDescription
Record of apgar score2009.1-2022.12To 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
Number of resuscitation history2009.1-2022.12To 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
Number of circulatory disorders2009.1-2022.12To 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.
Number of early-onset sepsis2009.1-2022.12To 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
Number of convulsions2009.1-2022.12To 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
Record of gestational age2009.1-2022.12To 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
Number of gestational hypertension2009.1-2022.12To identify the high risk factors of brain white matter injury in late preterm infants,gestational hypertension(mmHg) of every mother will be recorded
Number of diabetes mellitus2009.1-2022.12To identify the high risk factors of brain white matter injury in late preterm infants,diabetes mellitus(yes/no) of every mother will be recorded
Number of premature rupture of membranes2009.1-2022.12To 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
Number of placental abruption2009.1-2022.12To identify the high risk factors of brain white matter injury in late preterm infants,placental abruption(yes/no) of every mother will be recorded
Record of delivery by cesarean section2009.1-2022.12To 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
Record of weight2009.1-2022.12To identify the high risk factors of brain white matter injury in late preterm infants,weight(g) of every late preterm infant will be recorded
Record of gender2009.1-2022.12To 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
Record of small for gestational age2009.1-2022.12To 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

Countries

China

Contacts

Primary ContactDan Chen, master
youdrop@sina.com+8618940259088

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026