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

Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02831010
• Other study ID #: EKYYEOPMC
• Status: Completed
• Start date: April 2014
• Est. completion date: December 2020

Study information

• Verified date: October 2021
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 761
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

Inclusion Criteria:

• preterm infants with gestational age less than 32 weeks

Exclusion Criteria:

• major congenital malformations

• chromosomal disorders

• metabolic diseases

Related Conditions & MeSH terms

• Brain Diseases
• Encephalopathy
• Premature Birth

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Maternal and Child Health Hospital of Guiyang Province	Guiyang	Guizhou
China	Handan Central Hospital	Handan	Hebei
China	The First People's Hospital of Hefei	Hefei	Anhui
China	First Affiliated Hospital of Kunming Medical University	Kunming	Yunnan
China	Ningbo Women's and Children's Hospital	Ningbo	Zhejiang
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Shanghai First Maternity and Infant Hospital	Shanghai	Shanghai
China	First Affiliated Hospital of Xinjiang Medical University	Ürümqi	Xinjiang
China	Xiamen Women's and Children's Health Centre	Xiamen	Fujian
China	Shanxi Provincial Maternity and Children's Hospital	Xian	Shanxi
China	People's Hospital of Zhangzhou	Zhangzhou	Fujian
China	Zhongshan Bo Ai Hospital	Zhongshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. — View Citation

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:S1. doi: 10.1186/1742-4755-10-S1-S1. Epub 2013 Nov 15. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Volpe JJ. Encephalopathy of prematurity includes neuronal abnormalities. Pediatrics. 2005 Jul;116(1):221-5. Review. Erratum in: Pediatrics. 2006 Oct;118(4):1807. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	developmental quotient (DQ) on the Gesell Developmental Schedules	Result of gross motor, fine motor, language and social test. DQ = Development Age / Chronological Age X 100	2 years
Secondary	brain injury showed on MRI	signal abnormality in white matter, grey matter or cerebellum injury; periventricular leukomalacia; intracranial hemorrhage	36-40 weeks' postmenstrual age or before discharge
Secondary	morbidity of encephalopathy of prematurity	white matter injury, grey matter injury, cerebellum injury on MRI	36-40 weeks' postmenstrual age or before discharge
Secondary	all cause mortality	Mortality that does not require judgments about the cause of death	2 years
Secondary	neurodevelopment sequelae	including cerebral palsy, epilepsy, hearing loss, vision loss, etc.	2 years