Epidemiology Study on Neonatal Seizure

Seizures Clinical Trial

Official title:

A Multi-Centre Epidemiology Study on Neonatal Seizure in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02605031
• Other study ID #: PHDehong_NNICU6
• Status: Not yet recruiting
• Phase: N/A
• First received: November 9, 2015
• Last updated: November 11, 2015
• Start date: November 2015
• Est. completion date: December 2018

Study information

• Verified date: November 2015
• Source: The People's Hospital of Dehong Autonomous Prefecture
• Contact: Zhaoqing Yin, bachelor
• Email: zhaoqingyin99[@]sina.com
• Is FDA regulated: No
• Health authority: China: Health and Family planning commision Dehong Autonomous Prefecture of Dai and Jingpo Ethnic Groups,Yunnnan Province
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1400
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 28 Days

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Seizures

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
The People's Hospital of Dehong Autonomous Prefecture	Children's Hospital of Fudan University, Guangzhou Women and Children's Medical Center, Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region, Maternal and Child Health Hospital of Hubei Province, Second Affiliated Hospital of Wenzhou Medical University, Xiamen Children's Hospital, Fujian of China

References & Publications (9)

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. — View Citation

Grünebaum 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. — View 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. Review. — View 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. — View 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. — View 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. — View Citation

Sánchez Fernández 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, Sánchez 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	EEG	To measured by EEG after seizure attack.	In 14 Days after seizure attack	No
Secondary	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).	At corrected age of 18 months	No
Secondary	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).For malformation patients we will use genomic methods to observe neurological evaluation.	At corrected age of 18 months	No
Secondary	Gene Mutation	Using genomic methods to detect the mutation and characterize the genetic architecture and risk variants of neonatal malformation patients.	30 days after receipt of DNA sample	Yes