NCT02831010

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
761

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

5.7 years

First QC Date

July 10, 2016

Last Update Submit

October 11, 2021

Conditions

Encephalopathy

Keywords

prematurity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • brain injury showed on MRI

    36-40 weeks' postmenstrual age or before discharge

  • morbidity of encephalopathy of prematurity

    36-40 weeks' postmenstrual age or before discharge

  • all cause mortality

    2 years

  • neurodevelopment sequelae

    2 years

Study Arms (2)

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

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

neonatal intensive-care units

You may qualify if:

  • preterm infants with gestational age less than 32 weeks

You may not qualify if:

  • major congenital malformations
  • chromosomal disorders
  • metabolic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

The First People's Hospital of Hefei

Hefei, Anhui, 230000, China

Location

Xiamen Women's and Children's Health Centre

Xiamen, Fujian, 361000, China

Location

People's Hospital of Zhangzhou

Zhangzhou, Fujian, 363000, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Zhongshan Bo Ai Hospital

Zhongshan, Guangdong, 582400, China

Location

Maternal and Child Health Hospital of Guiyang Province

Guiyang, Guizhou, 550003, China

Location

Handan Central Hospital

Handan, Hebei, 056001, China

Location

First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 201204, China

Location

Shanxi Provincial Maternity and Children's Hospital

Xian, Shanxi, 710061, China

Location

First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830054, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China

Location

Ningbo Women's and Children's Hospital

Ningbo, Zhejiang, 315012, China

Location

Related Publications (9)

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

    PMID: 15995055BACKGROUND

  • 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.

    PMID: 20064132BACKGROUND

  • 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.

    PMID: 19081519BACKGROUND

  • 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.

    PMID: 25205706BACKGROUND

  • 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.

    PMID: 21907243BACKGROUND

  • 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.

    PMID: 20664400BACKGROUND

  • 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.

    PMID: 24625113BACKGROUND

  • 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.

    PMID: 20961565BACKGROUND

  • 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.

    PMID: 21535310BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, tissue

MeSH Terms

Conditions

Brain DiseasesPremature Birth

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Chao Chen, PhD, MD

    Children's Hospital of Fudan University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2016

First Posted

July 13, 2016

Study Start

April 1, 2014

Primary Completion

December 1, 2019

Study Completion

December 1, 2020

Last Updated

October 12, 2021

Record last verified: 2021-10

Locations

CN(14)