Clinical trial NCT02552511: Epidemiology Study on Neonatal Seizure
Official title: A Multi-Centre Epidemiology Study on Neonatal Seizure in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Seizures
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Xiamen Children's Hospital, Fujian of China
name: Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region
name: Guangzhou Women and Children's Medical Center
name: Second Affiliated Hospital of Wenzhou Medical University
name: Maternal and Child Health Hospital of Hubei Province
name: The People's Hospital of Dehong Autonomous Prefecture
name: Guangzhou Medical University
name: Nanfang Hospital of Southern Medical University, Guangdong of China
First posted: 2015-09-17
Enrollment: 1400
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All inpatients and Outpatients of neonates

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of new-onset or newly-diagnosed seizure in the neonatal population and stratified by epilepsy status.
timeFrame: Participants will be followed for the duration of neonatal from birth to 28 day, an expected average of 28 days.
Secondary outcomes:
measure: EEG
timeFrame: In 14 Days after seizure attack
measure: Neurodevelopment(Bayley Scores)
timeFrame: At corrected age of 18 months
measure: Neurological Evaluation(GMFM-88 Scores)
timeFrame: At corrected age of 18 months
measure: Gene Mutation
timeFrame: 30 days after receipt of DNA sample
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Wenhao Zhou, Doctor
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Wilden JA, Cohen-Gadol AA. Evaluation of first nonfebrile seizures. Am Fam Physician. 2012 Aug 15;86(4):334-40.