Brain White Matter Injury in Late Preterm Infants

White Matter Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04508517
• Other study ID #: DChen
• Status: Recruiting
• Start date: January 2009
• Est. completion date: December 2022

Study information

• Verified date: August 2020
• Source: Shengjing Hospital
• Contact: Dan Chen, master
• Phone: +8618940259088
• Email: youdrop[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• White Matter Injury
• Wounds and Injuries

Locations

Country	Name	City	State
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

References & Publications (22)

Arrigoni F, Parazzini C, Righini A, Doneda C, Ramenghi LA, Lista G, Triulzi F. Deep medullary vein involvement in neonates with brain damage: an MR imaging study. AJNR Am J Neuroradiol. 2011 Dec;32(11):2030-6. doi: 10.3174/ajnr.A2687. Epub 2011 Sep 29. — View Citation

Ballabh P, Braun A, Nedergaard M. Anatomic analysis of blood vessels in germinal matrix, cerebral cortex, and white matter in developing infants. Pediatr Res. 2004 Jul;56(1):117-24. Epub 2004 May 5. — View Citation

Benninger KL, Maitre NL, Ruess L, Rusin JA. MR Imaging Scoring System for White Matter Injury after Deep Medullary Vein Thrombosis and Infarction in Neonates. AJNR Am J Neuroradiol. 2019 Feb;40(2):347-352. doi: 10.3174/ajnr.A5940. Epub 2019 Jan 17. — View Citation

deVeber G, Andrew M, Adams C, Bjornson B, Booth F, Buckley DJ, Camfield CS, David M, Humphreys P, Langevin P, MacDonald EA, Gillett J, Meaney B, Shevell M, Sinclair DB, Yager J; Canadian Pediatric Ischemic Stroke Study Group. Cerebral sinovenous thrombosi — View Citation

Doneda C, Righini A, Parazzini C, Arrigoni F, Rustico M, Triulzi F. Prenatal MR imaging detection of deep medullary vein involvement in fetal brain damage. AJNR Am J Neuroradiol. 2011 Sep;32(8):E146-9. doi: 10.3174/ajnr.A2249. Epub 2010 Oct 14. — View Citation

du Plessis AJ. Cerebrovascular injury in premature infants: current understanding and challenges for future prevention. Clin Perinatol. 2008 Dec;35(4):609-41, v. doi: 10.1016/j.clp.2008.07.010. Review. — View Citation

Gould SJ, Howard S, Hope PL, Reynolds EO. Periventricular intraparenchymal cerebral haemorrhage in preterm infants: the role of venous infarction. J Pathol. 1987 Mar;151(3):197-202. — View Citation

Guihard-Costa AM, Larroche JC. Differential growth between the fetal brain and its infratentorial part. Early Hum Dev. 1990 Jun;23(1):27-40. — View Citation

Hüppi PS, Warfield S, Kikinis R, Barnes PD, Zientara GP, Jolesz FA, Tsuji MK, Volpe JJ. Quantitative magnetic resonance imaging of brain development in premature and mature newborns. Ann Neurol. 1998 Feb;43(2):224-35. — View Citation

Kinney HC. The near-term (late preterm) human brain and risk for periventricular leukomalacia: a review. Semin Perinatol. 2006 Apr;30(2):81-8. Review. — View Citation

Limperopoulos C, Soul JS, Gauvreau K, Huppi PS, Warfield SK, Bassan H, Robertson RL, Volpe JJ, du Plessis AJ. Late gestation cerebellar growth is rapid and impeded by premature birth. Pediatrics. 2005 Mar;115(3):688-95. — View Citation

Martinez-Biarge M, Groenendaal F, Kersbergen KJ, Benders MJ, Foti F, Cowan FM, de Vries LS. MRI Based Preterm White Matter Injury Classification: The Importance of Sequential Imaging in Determining Severity of Injury. PLoS One. 2016 Jun 3;11(6):e0156245. — View Citation

Moharir MD, Shroff M, Pontigon AM, Askalan R, Yau I, Macgregor D, Deveber GA. A prospective outcome study of neonatal cerebral sinovenous thrombosis. J Child Neurol. 2011 Sep;26(9):1137-44. doi: 10.1177/0883073811408094. Epub 2011 May 31. — View Citation

Nakamura Y, Okudera T, Hashimoto T. Vascular architecture in white matter of neonates: its relationship to periventricular leukomalacia. J Neuropathol Exp Neurol. 1994 Nov;53(6):582-9. — View Citation

Petrini JR, Dias T, McCormick MC, Massolo ML, Green NS, Escobar GJ. Increased risk of adverse neurological development for late preterm infants. J Pediatr. 2009 Feb;154(2):169-76. doi: 10.1016/j.jpeds.2008.08.020. Epub 2008 Dec 10. — View Citation

Pierson CR, Folkerth RD, Billiards SS, Trachtenberg FL, Drinkwater ME, Volpe JJ, Kinney HC. Gray matter injury associated with periventricular leukomalacia in the premature infant. Acta Neuropathol. 2007 Dec;114(6):619-31. Epub 2007 Oct 3. — View Citation

Ramenghi LA, Govaert P, Fumagalli M, Bassi L, Mosca F. Neonatal cerebral sinovenous thrombosis. Semin Fetal Neonatal Med. 2009 Oct;14(5):278-83. doi: 10.1016/j.siny.2009.07.010. Epub 2009 Aug 20. Review. — View Citation

Saxonhouse MA. Thrombosis in the Neonatal Intensive Care Unit. Clin Perinatol. 2015 Sep;42(3):651-73. doi: 10.1016/j.clp.2015.04.010. Review. — View Citation

Takashima S, Mito T, Ando Y. Pathogenesis of periventricular white matter hemorrhages in preterm infants. Brain Dev. 1986;8(1):25-30. — View Citation

Taoka T, Fukusumi A, Miyasaka T, Kawai H, Nakane T, Kichikawa K, Naganawa S. Structure of the Medullary Veins of the Cerebral Hemisphere and Related Disorders. Radiographics. 2017 Jan-Feb;37(1):281-297. doi: 10.1148/rg.2017160061. Review. — View Citation

Vilan A, Ribeiro JM, Reis C, Sampaio L. Deep Medullary Veins and Brain Injury. J Pediatr. 2018 Sep;200:290-290.e1. doi: 10.1016/j.jpeds.2018.03.051. Epub 2018 May 3. — View Citation

Yang JY, Chan AK, Callen DJ, Paes BA. Neonatal cerebral sinovenous thrombosis: sifting the evidence for a diagnostic plan and treatment strategy. Pediatrics. 2010 Sep;126(3):e693-700. doi: 10.1542/peds.2010-1035. Epub 2010 Aug 9. Review. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Imaging evaluation of different types of white matter injury in late preterm infants	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
Primary	Imaging differentiation of hemorrhagic and non hemorrhagic injuries	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
Primary	Number of late preterm infants and distribution of gray matter injury in late preterm infants with white matter injury	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
Primary	The number and distribution of PVL like injury in white matter injury of late preterm infants	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	Record of gestational age	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
Secondary	Record of weight	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
Secondary	Record of gender	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
Secondary	Record of small for gestational age	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
Secondary	Record of apgar score	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
Secondary	Number of resuscitation history	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
Secondary	Number of circulatory disorders	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
Secondary	Number of early-onset sepsis	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
Secondary	Number of convulsions	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
Secondary	Record of delivery by cesarean section	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
Secondary	Number of gestational hypertension	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
Secondary	Number of diabetes mellitus	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
Secondary	Number of premature rupture of membranes	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
Secondary	Number of placental abruption	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