Clinical trial NCT04508517: Brain White Matter Injury in Late Preterm Infants
Official title: A Cohort Study on the Etiology and Pathological Types of Brain White Matter Injury in Late Preterm Infants
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: White Matter Injury
Keywords: white matter injury;late preterm infants
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2020-08-11
Enrollment: 3000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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

Primary outcomes:
measure: Imaging evaluation of different types of white matter injury in late preterm infants
timeFrame: 2009.1-2022.12
measure: Imaging differentiation of hemorrhagic and non hemorrhagic injuries
timeFrame: 2009.1-2022.12
measure: Number of late preterm infants and distribution of gray matter injury in late preterm infants with white matter injury
timeFrame: 2009.1-2022.12
measure: The number and distribution of PVL like injury in white matter injury of late preterm infants
timeFrame: 2009.1-2022.12
Secondary outcomes:
measure: Record of gestational age
timeFrame: 2009.1-2022.12
measure: Record of weight
timeFrame: 2009.1-2022.12
measure: Record of gender
timeFrame: 2009.1-2022.12
measure: Record of small for gestational age
timeFrame: 2009.1-2022.12
measure: Record of apgar score
timeFrame: 2009.1-2022.12
measure: Number of resuscitation history
timeFrame: 2009.1-2022.12
measure: Number of circulatory disorders
timeFrame: 2009.1-2022.12
measure: Number of early-onset sepsis
timeFrame: 2009.1-2022.12
measure: Number of convulsions
timeFrame: 2009.1-2022.12
measure: Record of delivery by cesarean section
timeFrame: 2009.1-2022.12
measure: Number of gestational hypertension
timeFrame: 2009.1-2022.12
measure: Number of diabetes mellitus
timeFrame: 2009.1-2022.12
measure: Number of premature rupture of membranes
timeFrame: 2009.1-2022.12
measure: Number of placental abruption
timeFrame: 2009.1-2022.12
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
Study officials:
affiliation: Shengjing Hospital
name: Jian Mao, doctor
role: STUDY_DIRECTOR
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