Review

. 2019 Dec 10;37(52):7596-7609.

doi: 10.1016/j.vaccine.2019.05.031.

Neonatal seizures: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Serena Pellegrin¹, Flor M Munoz², Michael Padula³, Paul T Heath⁴, Lee Meller⁵, Karina Top⁶, Jo Wilmshurst⁷, Max Wiznitzer⁸, Manoja Kumar Das⁹, Cecil D Hahn¹⁰, Merita Kucuku¹¹, James Oleske¹², Kollencheri Puthenveettil Vinayan¹³, Elissa Yozawitz¹⁴, Satinder Aneja¹⁵, Niranjan Bhat¹⁶, Geraldine Boylan¹⁷, Sanie Sesay¹⁸, Anju Shrestha¹⁹, Janet S Soul²⁰, Beckie Tagbo²¹, Jyoti Joshi²², Aung Soe²³, Helena C Maltezou²⁴, Jane Gidudu²⁵, Sonali Kochhar²⁶, Ronit M Pressler²⁷; Brighton Collaboration Neonatal Seizures Working Group

Affiliations

¹ Clinical Neuroscience, UCL-Institute of Child Health, London, UK; Department of Child Neuropsychiatry, University of Verona, Verona, Italy.
² Baylor College of Medicine, Department of Pediatrics, Houston, TX, USA.
³ The Children's Hospital of Philadelphia, PA, USA.
⁴ Vaccine Institute, St Georges University of London, London, UK.
⁵ Syneos Health, Safety & Pharmacovigilance, Raleigh, NC, USA.
⁶ Department of Pediatrics, Dalhousie University, Halifax, NS, Canada.
⁷ Department of Paediatric Neurology, Red Cross War Memorial Children's Hospital, Neuroscience Institute, University of Cape Town, South Africa.
⁸ Rainbow Babies & Children's Hospital, Cleveland, OH, USA.
⁹ The INCLEN Trust International, New Delhi, India.
¹⁰ Division of Neurology, The Hospital for Sick Children and Department of Paediatrics, University of Toronto, Toronto, Canada.
¹¹ National Agency for Medicines and Medical Devices, Tirana, Albania.
¹² Department of Pediatrics, Rutgers - New Jersey Medical School, Newark, NJ, USA.
¹³ Division of Pediatric Neurology, Department of Neurology, Amrita Institute of Medical Sciences, Cochin, Kerala, India.
¹⁴ Saul R. Korey Department of Neurology, Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, USA.
¹⁵ Department of Pediatrics, School of Medical Sciences & Research, Sharda University, Gr Noida, India.
¹⁶ Center for Vaccine Innovation and Access PATH, Seattle, WA, USA.
¹⁷ INFANT Research Centre, University College Cork, Ireland.
¹⁸ Clinical Sciences, Sanofi Pasteur, Marcy L'Etoile, France.
¹⁹ Sanofi Pasteur, Global Pharmacovigilance, PA, USA.
²⁰ Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
²¹ Institute of Child Health, University of Nigeria Teaching Hospital, Nigeria.
²² Center for Disease Dynamics, Economics & Policy, New Delhi, India.
²³ Medway NHS Foundation Trust, Kent, UK.
²⁴ Department for Interventions in Healthcare Facilities, Hellenic Center for Disease Control and Prevention, Athens, Greece.
²⁵ Centers for Disease Control and Prevention, Global Immunization Division, Atlanta, USA.
²⁶ Global Healthcare Consulting, New Delhi, India; Department of Public Health, Erasmus MC, University Medical Center, Rotterdam, the Netherlands; Department of Global Health, University of Washington, Seattle, USA.
²⁷ Clinical Neuroscience, UCL-Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK. Electronic address: contact@brightoncollaboration.org.

PMID: 31783981
PMCID: PMC6899436
DOI: 10.1016/j.vaccine.2019.05.031

Review

Neonatal seizures: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Serena Pellegrin et al. Vaccine. 2019.

. 2019 Dec 10;37(52):7596-7609.

doi: 10.1016/j.vaccine.2019.05.031.

Authors

Affiliations

¹ Clinical Neuroscience, UCL-Institute of Child Health, London, UK; Department of Child Neuropsychiatry, University of Verona, Verona, Italy.
² Baylor College of Medicine, Department of Pediatrics, Houston, TX, USA.
³ The Children's Hospital of Philadelphia, PA, USA.
⁴ Vaccine Institute, St Georges University of London, London, UK.
⁵ Syneos Health, Safety & Pharmacovigilance, Raleigh, NC, USA.
⁶ Department of Pediatrics, Dalhousie University, Halifax, NS, Canada.
⁷ Department of Paediatric Neurology, Red Cross War Memorial Children's Hospital, Neuroscience Institute, University of Cape Town, South Africa.
⁸ Rainbow Babies & Children's Hospital, Cleveland, OH, USA.
⁹ The INCLEN Trust International, New Delhi, India.
¹⁰ Division of Neurology, The Hospital for Sick Children and Department of Paediatrics, University of Toronto, Toronto, Canada.
¹¹ National Agency for Medicines and Medical Devices, Tirana, Albania.
¹² Department of Pediatrics, Rutgers - New Jersey Medical School, Newark, NJ, USA.
¹³ Division of Pediatric Neurology, Department of Neurology, Amrita Institute of Medical Sciences, Cochin, Kerala, India.
¹⁴ Saul R. Korey Department of Neurology, Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY, USA.
¹⁵ Department of Pediatrics, School of Medical Sciences & Research, Sharda University, Gr Noida, India.
¹⁶ Center for Vaccine Innovation and Access PATH, Seattle, WA, USA.
¹⁷ INFANT Research Centre, University College Cork, Ireland.
¹⁸ Clinical Sciences, Sanofi Pasteur, Marcy L'Etoile, France.
¹⁹ Sanofi Pasteur, Global Pharmacovigilance, PA, USA.
²⁰ Department of Neurology, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.
²¹ Institute of Child Health, University of Nigeria Teaching Hospital, Nigeria.
²² Center for Disease Dynamics, Economics & Policy, New Delhi, India.
²³ Medway NHS Foundation Trust, Kent, UK.
²⁴ Department for Interventions in Healthcare Facilities, Hellenic Center for Disease Control and Prevention, Athens, Greece.
²⁵ Centers for Disease Control and Prevention, Global Immunization Division, Atlanta, USA.
²⁶ Global Healthcare Consulting, New Delhi, India; Department of Public Health, Erasmus MC, University Medical Center, Rotterdam, the Netherlands; Department of Global Health, University of Washington, Seattle, USA.
²⁷ Clinical Neuroscience, UCL-Institute of Child Health, London, UK; Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK. Electronic address: contact@brightoncollaboration.org.

PMID: 31783981
PMCID: PMC6899436
DOI: 10.1016/j.vaccine.2019.05.031

No abstract available

Keywords: Adverse event; Case definition; Guidelines; Immunization; Neonatal seizures.

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Conflict of interest statement

The authors declared that there is no conflict of interest.

Figures

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References

1. Barlow W.E., Davis R.L., Glasser J.W., Rhodes P.H., Thompson R.S., Mullooly J.P. The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine. N Engl J Med. 2001;345:656–661. - PubMed
1. Top K.A., Brna P., Ye L., Smith B. Risk of seizures after immunization in children with epilepsy: a risk interval analysis. BMC Pediatr. 2018;18:134. - PMC - PubMed
1. Bonhoeffer J., Menkes J., Gold M.S., de Souza-Brito G., Fisher M.C., Halsey N. Generalized convulsive seizure as an adverse event following immunization: case definition and guidelines for data collection, analysis, and presentation. Vaccine. 2004;22:557–562. - PubMed
1. Plouin P., Kaminska A. Chapter 51 - neonatal seizures. In: Dulac O., Lassonde M., Sarnat H.B., editors. Handbook of clinical neurology. Elsevier; 2013. pp. 467–476. - PubMed
1. Vasudevan C., Levene M. Epidemiology and aetiology of neonatal seizures. Sem Fetal Neonatal Med. 2013;18:185–191. - PubMed

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Neonatal seizures: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Affiliations

Neonatal seizures: Case definition & guidelines for data collection, analysis, and presentation of immunization safety data

Authors

Affiliations

Conflict of interest statement

Figures

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Medical