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EncephalopathyNCT02831010

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

An observational study of Encephalopathy, run by Children's Hospital of Fudan University at 14 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 28 days
Conditions the study is for
Encephalopathy
How many people
761 participants
Where
14 sitesChina
Study dates
Apr 2014to Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 28 days
  • All sexes
  • No healthy volunteers
  • Child

Study population: neonatal intensive-care units

Who may be able to join

  • preterm infants with gestational age less than 32 weeks

Who cannot join

  • major congenital malformations
  • chromosomal disorders
  • metabolic diseases

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

China14 sites

  • First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510260

  • Maternal and Child Health Hospital of Guiyang Province

    Guiyang, Guizhou, 550003

  • Handan Central Hospital

    Handan, Hebei, 056001

  • The First People's Hospital of Hefei

    Hefei, Anhui, 230000

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan, 650032

  • Ningbo Women's and Children's Hospital

    Ningbo, Zhejiang, 315012

  • Children's Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102

  • Shanghai First Maternity and Infant Hospital

    Shanghai, Shanghai Municipality, 201204

  • First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • Xiamen Women's and Children's Health Centre

    Xiamen, Fujian, 361000

  • Shanxi Provincial Maternity and Children's Hospital

    Xian, Shanxi, 710061

  • People's Hospital of Zhangzhou

    Zhangzhou, Fujian, 363000

  • Zhongshan Bo Ai Hospital

    Zhongshan, Guangdong, 582400

Other trials in China

About this study

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.

Read the 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.

Conditions
Encephalopathy
Keywords
prematurity
Medical subject headings
Brain Diseases, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02831010
Study groupRoleWhat they receive
encephalopathy of prematurityinfants with encephalopathy of prematurity showed on MRI at term-equivalent age
no encephalopathy of prematurityinfants with no encephalopathy of prematurity showed on MRI at term-equivalent age

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 years

Secondary outcomes (4)

  1. brain injury showed on MRI

    signal abnormality in white matter, grey matter or cerebellum injury; periventricular leukomalacia; intracranial hemorrhage

    Measured: 36-40 weeks' postmenstrual age or before discharge

  2. morbidity of encephalopathy of prematurity

    white matter injury, grey matter injury, cerebellum injury on MRI

    Measured: 36-40 weeks' postmenstrual age or before discharge

  3. all cause mortality

    Mortality that does not require judgments about the cause of death

    Measured: 2 years

  4. neurodevelopment sequelae

    including cerebral palsy, epilepsy, hearing loss, vision loss, etc.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2016 (estimated)
  2. Study startApr 2014
  3. Primary completionDec 2019
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
761 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02831010
Sponsor's protocol ID
EKYYEOPMC
Status last verified
Oct 2021
First submitted
10 Jul 2016
Last updated
12 Oct 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

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

    PubMed 15995055

  • 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.

    PubMed 20064132

  • 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.

    PubMed 19081519

  • 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.

    PubMed 25205706

  • 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.

    PubMed 21907243

  • 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.

    PubMed 20664400

  • 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.

    PubMed 24625113

  • 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.

    PubMed 20961565

  • 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.

    PubMed 21535310

Questions about this trial

What is this clinical trial studying?

An observational study of Encephalopathy, run by Children's Hospital of Fudan University at 14 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

developmental quotient (DQ) on the Gesell Developmental Schedules (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02831010, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.

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