Brain White Matter Injury in Late Preterm Infants
- Conditions
- White Matter Injury
- Registration Number
- NCT04508517
- Lead Sponsor
- Shengjing Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3000
- MRI head examination with informed consent of guardian
- Age 34-36+6 weeks
- Other encephalopathies or congenital abnormality of brain development except white matter injury were excluded
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of late preterm infants and distribution of gray matter injury in late preterm infants with white matter injury 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 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 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 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 Outcome Measures
Name Time Method Number of early-onset sepsis 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
Record of small for gestational age 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
Record of gestational age 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
Record of gender 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
Record of apgar score 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
Number of circulatory disorders 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.
Number of convulsions 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
Record of weight 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
Number of resuscitation history 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
Record of delivery by cesarean section 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
Number of gestational hypertension 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
Number of diabetes mellitus 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
Number of premature rupture of membranes 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
Number of placental abruption 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
Trial Locations
- Locations (1)
Shengjing Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China