A Multi-Center Cohort Study of Risk Factors and Outcomes of Encephalopathy of Prematurity in China

Overview

The purpose of this study is to explore the perinatal risk factors of encephalopathy of prematurity and the morbidity of the following neurodevelopmental impairments in preterm infants with gestational age <32 weeks in China.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2019

Detailed Description

Recent years have witnessed an increase in survival of very or extremely low birth weight infants, with a corresponding increase of attention to encephalopathy of prematurity (EOP) and the following neurological disorders. Studies suggested that hypoxic-ischemic injury and perinatal infection might be the two main risk factors of EOP, including white matter injury, neuronal-axonal diseases and cerebellar hemorrhage, which have a strong impact on neurological outcomes. Sequelae like cerebral palsy or mental retardation become a burden to both the family and society. Therefore, the risk factors of brain injury become the critical issue of both Obstetrics and Neonatology. More importantly, little is known about the morbidity of neurodevelopmental impairment and its risk factors in China. Thus, the aim of our study is to explore the perinatal risk factors of encephalopathy of prematurity and the morbidity of the following neurodevelopmental impairments in preterm infants with gestational age <32 weeks in China.

Arms, Groups and Cohorts

  • encephalopathy of prematurity
    • infants with encephalopathy of prematurity showed on MRI at term-equivalent age
  • no encephalopathy of prematurity
    • infants with no encephalopathy of prematurity showed on MRI at term-equivalent age

Clinical Trial Outcome Measures

Primary Measures

  • developmental quotient (DQ) on the Gesell Developmental Schedules
    • Time Frame: 2 years
    • Result of gross motor, fine motor, language and social test. DQ = Development Age / Chronological Age X 100

Secondary Measures

  • brain injury showed on MRI
    • Time Frame: 36-40 weeks’ postmenstrual age or before discharge
    • signal abnormality in white matter, grey matter or cerebellum injury; periventricular leukomalacia; intracranial hemorrhage
  • morbidity of encephalopathy of prematurity
    • Time Frame: 36-40 weeks’ postmenstrual age or before discharge
    • white matter injury, grey matter injury, cerebellum injury on MRI
  • all cause mortality
    • Time Frame: 2 years
    • Mortality that does not require judgments about the cause of death
  • neurodevelopment sequelae
    • Time Frame: 2 years
    • including cerebral palsy, epilepsy, hearing loss, vision loss, etc.

Participating in This Clinical Trial

Inclusion Criteria

  • preterm infants with gestational age less than 32 weeks Exclusion Criteria:

  • major congenital malformations – chromosomal disorders – metabolic diseases

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 28 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital of Fudan University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Chao Chen, PhD, MD, Study Director, Children’s Hospital of Fudan University

References

Volpe JJ. Encephalopathy of prematurity includes neuronal abnormalities. Pediatrics. 2005 Jul;116(1):221-5. doi: 10.1542/peds.2005-0191. No abstract available. Erratum In: Pediatrics. 2006 Oct;118(4):1807.

Groenendaal F, Termote JU, van der Heide-Jalving M, van Haastert IC, de Vries LS. Complications affecting preterm neonates from 1991 to 2006: what have we gained? Acta Paediatr. 2010 Mar;99(3):354-8. doi: 10.1111/j.1651-2227.2009.01648.x. Epub 2010 Jan 8.

Volpe JJ. Brain injury in premature infants: a complex amalgam of destructive and developmental disturbances. Lancet Neurol. 2009 Jan;8(1):110-24. doi: 10.1016/S1474-4422(08)70294-1.

Korzeniewski SJ, Romero R, Cortez J, Pappas A, Schwartz AG, Kim CJ, Kim JS, Kim YM, Yoon BH, Chaiworapongsa T, Hassan SS. A "multi-hit" model of neonatal white matter injury: cumulative contributions of chronic placental inflammation, acute fetal inflammation and postnatal inflammatory events. J Perinat Med. 2014 Nov;42(6):731-43. doi: 10.1515/jpm-2014-0250.

Sominsky L, Walker AK, Ong LK, Tynan RJ, Walker FR, Hodgson DM. Increased microglial activation in the rat brain following neonatal exposure to a bacterial mimetic. Behav Brain Res. 2012 Jan 1;226(1):351-6. doi: 10.1016/j.bbr.2011.08.038. Epub 2011 Sep 1.

Shatrov JG, Birch SCM, Lam LT, Quinlivan JA, McIntyre S, Mendz GL. Chorioamnionitis and cerebral palsy: a meta-analysis. Obstet Gynecol. 2010 Aug;116(2 Pt 1):387-392. doi: 10.1097/AOG.0b013e3181e90046.

Howson CP, Kinney MV, McDougall L, Lawn JE; Born Too Soon Preterm Birth Action Group. Born too soon: preterm birth matters. Reprod Health. 2013;10 Suppl 1(Suppl 1):S1. doi: 10.1186/1742-4755-10-S1-S1. Epub 2013 Nov 15.

Hendson L, Russell L, Robertson CM, Liang Y, Chen Y, Abdalla A, Lacaze-Masmonteil T. Neonatal and neurodevelopmental outcomes of very low birth weight infants with histologic chorioamnionitis. J Pediatr. 2011 Mar;158(3):397-402. doi: 10.1016/j.jpeds.2010.09.010. Epub 2010 Oct 18.

Sato M, Nishimaki S, Yokota S, Seki K, Horiguchi H, An H, Ishida F, Fujita S, Ao K, Yatake H. Severity of chorioamnionitis and neonatal outcome. J Obstet Gynaecol Res. 2011 Oct;37(10):1313-9. doi: 10.1111/j.1447-0756.2010.01519.x. Epub 2011 May 3.

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