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

doi:10.1016/j.vaccine.2019.05.031

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.

PubMed Disclaimer

Conflict of interest statement

The authors declared that there is no conflict of interest.

Figures

See this image and copyright information in PMC

Cited by

Temporal evolution of electrographic seizures in newborn infants with hypoxic-ischaemic encephalopathy requiring therapeutic hypothermia: a secondary analysis of the ANSeR studies.
Pavel AM, Rennie JM, de Vries LS, Mathieson SR, Livingstone V, Finder M, Foran A, Shah DK, Pressler RM, Weeke LC, Dempsey EM, Murray DM, Boylan GB; ANSeR Consortium. Pavel AM, et al. Lancet Child Adolesc Health. 2024 Mar;8(3):214-224. doi: 10.1016/S2352-4642(23)00296-1. Epub 2024 Jan 18. Lancet Child Adolesc Health. 2024. PMID: 38246187 Free PMC article. Clinical Trial.
Global Perspectives on Immunization During Pregnancy and Priorities for Future Research and Development: An International Consensus Statement.
Abu-Raya B, Maertens K, Edwards KM, Omer SB, Englund JA, Flanagan KL, Snape MD, Amirthalingam G, Leuridan E, Damme PV, Papaevangelou V, Launay O, Dagan R, Campins M, Cavaliere AF, Frusca T, Guidi S, O'Ryan M, Heininger U, Tan T, Alsuwaidi AR, Safadi MA, Vilca LM, Wanlapakorn N, Madhi SA, Giles ML, Prymula R, Ladhani S, Martinón-Torres F, Tan L, Michelin L, Scambia G, Principi N, Esposito S. Abu-Raya B, et al. Front Immunol. 2020 Jun 24;11:1282. doi: 10.3389/fimmu.2020.01282. eCollection 2020. Front Immunol. 2020. PMID: 32670282 Free PMC article. Review.
Incidence and predictors of neonatal seizures among neonates admitted in Debre Markos Comprehensive Specialized Hospital, Northwest Ethiopia. A prospective follow-up study.
Alemayehu T, Gebre T, Asmare B, Tafere Y, Kassie B, Tsega TD, Alemu M, Messelu MA. Alemayehu T, et al. Heliyon. 2024 Apr 22;10(9):e29999. doi: 10.1016/j.heliyon.2024.e29999. eCollection 2024 May 15. Heliyon. 2024. PMID: 38707374 Free PMC article.
The Role of Amplitude-Integrated Electroencephalography (aEEG) in Monitoring Infants with Neonatal Seizures and Predicting Their Neurodevelopmental Outcome.
Doandes FM, Manea AM, Lungu N, Brandibur T, Cioboata D, Costescu OC, Zaharie M, Boia M. Doandes FM, et al. Children (Basel). 2023 May 3;10(5):833. doi: 10.3390/children10050833. Children (Basel). 2023. PMID: 37238381 Free PMC article.
Defining neonatal status epilepticus: A scoping review from the ILAE neonatal task force.
Nunes ML, Yozawitz EG, Wusthoff CJ, Shellhaas RA, Olivas-Peña E, Wilmshurst JM, Pressler RM, Triki CC, Hartmann H, Inder T, Boylan GB, Valente K, Moshe SL, Mizrahi EM, Abend NS. Nunes ML, et al. Epilepsia Open. 2025 Feb;10(1):40-54. doi: 10.1002/epi4.13090. Epub 2024 Nov 14. Epilepsia Open. 2025. PMID: 39540265 Free PMC article.

See all "Cited by" articles

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

Publication types

Actions

MeSH terms

Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions
Actions

LinkOut - more resources

Full Text Sources
Medical
- ClinicalTrials.gov
- MedlinePlus Health Information

[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

[2] 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

[3] 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

[4] 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

[5] 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

[6] 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

[7] 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

[8] 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

[9] Vasudevan C., Levene M. Epidemiology and aetiology of neonatal seizures. Sem Fetal Neonatal Med. 2013;18:185–191. - PubMed

[10] Vasudevan C., Levene M. Epidemiology and aetiology of neonatal seizures. Sem Fetal Neonatal Med. 2013;18:185–191. - PubMed

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

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

Similar articles

Cited by

References

Publication types

MeSH terms

LinkOut - more resources

Full Text Sources

Medical