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SeizuresNCT02552511

Epidemiology Study on Neonatal Seizure

An observational study of Seizures, run by Children's Hospital of Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A Multicentre, observational and cohort study to get the incidence of new-onset or newly-diagnosed seizure in neonatal population. EEG will used to record the change of brain electric activity and diagnose. Other data also will be collected since first seizure until confirmed diagnosis. Read more about this study

Who is it for?
Ages Up to 28 days
Conditions the study is for
Seizures
How many people
1,400 participants
Where
1 siteChina
Study dates
1 Sep 2015to 30 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

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: All inpatients and Outpatients of neonates

Who may be able to join

  • Age from 0~28 days;
  • Clinical diagnosed with seizure;
  • EEG diagnosed with seizure;
  • Parents who consent to their participation in the study;

Who cannot join

  • Parents who will not comply to the needs and the design process.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenhao Zhou, Doctor contact

zwhchfu@126.com

Guoqiang Cheng, Doctor contact

gqchengcm@163.com

China1 site, 1 recruiting

  • Children Hospital of Fudan University

    Shanghai, Shanghai Municipality, 201102

    Wenhao Zhou, Doctor, (+86)021-64931003, zwhchfu@126.com

    Recruiting

Other trials in China

About this study

Official title: A Multi-Centre Epidemiology Study on Neonatal Seizure in China

A Multicentre, observational and cohort study to get the incidence of new-onset or newly-diagnosed seizure in neonatal population. EEG will used to record the change of brain electric activity and diagnose. Other data also will be collected since first seizure until confirmed diagnosis.

Read the detailed description

This study is designed to describe the incidence of newborn with uncontrolled seizures. Seizures can be associated with any high-risk factors during perinatal stage and diagnosed by abnormal electrical activity in the brain.

In this study researchers will use electroencephalography (EEG) to determine and monitor newborn with uncontrolled or suspected seizures. EEG works by measuring electrical activity in different areas of the brain. The EEG allows researchers to examine changes in the EEG along with the clinical features of seizures as they occur.

In addition to monitoring electrical activity of the brain, researchers will collect demographic, medical history, family, perinatal stage, birth, growth, feeding condition by medical records and questionnaire. These information will allow researchers to learn more about what high-risk factors influence the incidence of neonatal seizure in China.

Conditions
Seizures
Medical subject headings
Seizures

What participants receive

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

Study groups in NCT02552511
Study groupRoleWhat they receive
ExposurePerinatal factors exposure

What is being measured

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

  1. Incidence of new-onset or newly-diagnosed seizure in the neonatal population and stratified by epilepsy status.

    Incidence of new-onset or newly-diagnosed seizure in the neonatal population and stratified by epilepsy status.

    Measured: Participants will be followed for the duration of neonatal from birth to 28 day, an expected average of 28 days.

Secondary outcomes (4)

  1. EEG

    To measured by EEG after seizure attack.

    Measured: In 14 Days after seizure attack

  2. Neurodevelopment(Bayley Scores)

    To evaluate neurodevelopmental function via Bayley Scores of Infant Development Mental Development Index (BSID) and gain incidence of MDI<70(Severe) or MDI<85(Moderate).

    Measured: At corrected age of 18 months

  3. Neurological Evaluation(GMFM-88 Scores)

    To gain changes in standardized gross motor function using GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales, lying \& rolling, sitting, crawling \& kneeling, standing, walking, running \& jumping (range: 0~100 , Higher value means better gross motor function).malformation using genomic methods.

    Measured: At corrected age of 18 months

  4. Gene Mutation

    To detect the mutation and characterize the genetic architecture and risk variants of neonatal malformation using genomic methods.

    Measured: 30 days after receipt of DNA sample

Timeline

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

  1. First posted17 Sep 2015 (estimated)
  2. Study start1 Sep 2015
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

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
Case-control
Time perspective
Retrospective
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02552511
Sponsor's protocol ID
CHFudanU_NNICU6
Status last verified
Sep 2025
First submitted
4 Sep 2015
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Sen S, Keough K, Gibson J. Clinical reasoning: novel GLUT1-DS mutation: refractory seizures and ataxia. Neurology. 2015 Apr 14;84(15):e111-4. doi: 10.1212/WNL.0000000000001467.

    PubMed 25870456

  • Lateef TM, Johann-Liang R, Kaulas H, Hasan R, Williams K, Caserta V, Nelson KB. Seizures, encephalopathy, and vaccines: experience in the National Vaccine Injury Compensation Program. J Pediatr. 2015 Mar;166(3):576-81. doi: 10.1016/j.jpeds.2014.10.054. Epub 2014 Dec 2.

    PubMed 25477158

  • Payne ET, Zhao XY, Frndova H, McBain K, Sharma R, Hutchison JS, Hahn CD. Seizure burden is independently associated with short term outcome in critically ill children. Brain. 2014 May;137(Pt 5):1429-38. doi: 10.1093/brain/awu042. Epub 2014 Mar 4.

    PubMed 24595203

  • Sanchez Fernandez I, Abend NS, Arndt DH, Carpenter JL, Chapman KE, Cornett KM, Dlugos DJ, Gallentine WB, Giza CC, Goldstein JL, Hahn CD, Lerner JT, Matsumoto JH, McBain K, Nash KB, Payne E, Sanchez SM, Williams K, Loddenkemper T. Electrographic seizures after convulsive status epilepticus in children and young adults: a retrospective multicenter study. J Pediatr. 2014 Feb;164(2):339-46.e1-2. doi: 10.1016/j.jpeds.2013.09.032. Epub 2013 Oct 22.

    PubMed 24161223

  • Iyer A, Appleton R. Management of reflex anoxic seizures in children. Arch Dis Child. 2013 Sep;98(9):714-7. doi: 10.1136/archdischild-2012-303133. Epub 2013 Jun 28.

    PubMed 23814085

  • Grunebaum A, McCullough LB, Sapra KJ, Brent RL, Levene MI, Arabin B, Chervenak FA. Apgar score of 0 at 5 minutes and neonatal seizures or serious neurologic dysfunction in relation to birth setting. Am J Obstet Gynecol. 2013 Oct;209(4):323.e1-6. doi: 10.1016/j.ajog.2013.06.025. Epub 2013 Jun 19.

    PubMed 23791692

  • Beslow LA, Abend NS, Gindville MC, Bastian RA, Licht DJ, Smith SE, Hillis AE, Ichord RN, Jordan LC. Pediatric intracerebral hemorrhage: acute symptomatic seizures and epilepsy. JAMA Neurol. 2013 Apr;70(4):448-54. doi: 10.1001/jamaneurol.2013.1033.

    PubMed 23392319

  • Kidokoro H, Kubota T, Hayakawa M, Kato Y, Okumura A. Neonatal seizure identification on reduced channel EEG. Arch Dis Child Fetal Neonatal Ed. 2013 Jul;98(4):F359-61. doi: 10.1136/archdischild-2012-302361. Epub 2012 Oct 27.

    PubMed 23104986

  • Wilden JA, Cohen-Gadol AA. Evaluation of first nonfebrile seizures. Am Fam Physician. 2012 Aug 15;86(4):334-40.

    PubMed 22963022

Questions about this trial

What is this clinical trial studying?

An observational study of Seizures, run by Children's Hospital of Fudan University at 1 site 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Wenhao Zhou, Doctor (zwhchfu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of new-onset or newly-diagnosed seizure in the neonatal population and stratified by epilepsy status. (time frame: Participants will be followed for the duration of neonatal from birth to 28 day, an expected average of 28 days.). 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 NCT02552511, 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 5 Sep 2025.

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Epidemiology Study on Neonatal Seizure (NCT02552511) | AzTrials