Epidemiology Study on Neonatal Seizure

NCT02552511 | Recruiting DMC

• 1 other identifier: CHFudanU_NNICU6
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Seizures

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• EEG

  In 14 Days after seizure attack

• Neurodevelopment(Bayley Scores)

  At corrected age of 18 months

• Neurological Evaluation(GMFM-88 Scores)

  At corrected age of 18 months

• Gene Mutation

  30 days after receipt of DNA sample

Study Arms (1)

Exposure

Perinatal factors exposure

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All inpatients and Outpatients of neonates

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead
• Xiamen Children's Hospital, Fujian of China: collaborator
• Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Guangzhou Women and Children's Medical Center: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator
• Maternal and Child Health Hospital of Hubei Province: collaborator
• The People's Hospital of Dehong Autonomous Prefecture: collaborator
• Guangzhou Medical University: collaborator
• Nanfang Hospital of Southern Medical University, Guangdong of China: collaborator

Study Sites (1)

Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 25870456 BACKGROUND

• 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.

  PMID: 25477158 BACKGROUND

• 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.

  PMID: 24595203 BACKGROUND

• 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.

  PMID: 24161223 BACKGROUND

• 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.

  PMID: 23814085 BACKGROUND

• 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.

  PMID: 23791692 BACKGROUND

• 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.

  PMID: 23392319 BACKGROUND

• 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.

  PMID: 23104986 BACKGROUND

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

  PMID: 22963022 BACKGROUND

MeSH Terms

Conditions

Seizures

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenhao Zhou, Doctor

  Children's Hospital of Fudan University

  STUDY CHAIR

Central Study Contacts

Wenhao Zhou, Doctor

CONTACT

zwhchfu@126.com

Guoqiang Cheng, Doctor

CONTACT

gqchengcm@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 17, 2015
• Study Start: September 1, 2015
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-09

Locations

CN (1)