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

NCT ID: NCT02831010

Last Updated: 2021-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

761 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Encephalopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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encephalopathy of prematurity

infants with encephalopathy of prematurity showed on MRI at term-equivalent age

No interventions assigned to this group

no encephalopathy of prematurity

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* preterm infants with gestational age less than 32 weeks

Exclusion Criteria

* major congenital malformations
* chromosomal disorders
* metabolic diseases
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chao Chen, PhD, MD

Role: STUDY_DIRECTOR

Children's Hospital of Fudan University

Locations

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The First People's Hospital of Hefei

Hefei, Anhui, China

Site Status

Xiamen Women's and Children's Health Centre

Xiamen, Fujian, China

Site Status

People's Hospital of Zhangzhou

Zhangzhou, Fujian, China

Site Status

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

Zhongshan Bo Ai Hospital

Zhongshan, Guangdong, China

Site Status

Maternal and Child Health Hospital of Guiyang Province

Guiyang, Guizhou, China

Site Status

Handan Central Hospital

Handan, Hebei, China

Site Status

First Hospital of Jilin University

Changchun, Jilin, China

Site Status

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

Site Status

Shanxi Provincial Maternity and Children's Hospital

Xian, Shanxi, China

Site Status

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China

Site Status

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status

Ningbo Women's and Children's Hospital

Ningbo, Zhejiang, China

Site Status

Countries

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China

References

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

Reference Type BACKGROUND
PMID: 15995055 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20064132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19081519 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25205706 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21907243 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20664400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24625113 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20961565 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21535310 (View on PubMed)

Other Identifiers

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EKYYEOPMC

Identifier Type: -

Identifier Source: org_study_id

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