Congenital microcephaly: Case definition & guidelines for data collection, analysis, and presentation of safety data after maternal immunisation

doi:10.1016/j.vaccine.2017.01.044

Guideline

. 2017 Dec 4;35(48 Pt A):6472-6482.

doi: 10.1016/j.vaccine.2017.01.044.

Congenital microcephaly: Case definition & guidelines for data collection, analysis, and presentation of safety data after maternal immunisation

Malini DeSilva¹, Flor M Munoz², Erick Sell³, Helen Marshall⁴, Alison Tse Kawai⁵, Alisa Kachikis⁶, Paul Heath⁷, Nicola P Klein⁸, James M Oleske⁹, Fyezah Jehan¹⁰, Hans Spiegel¹¹, Mirjana Nesin¹², Beckie N Tagbo¹³, Anju Shrestha¹⁴, Clare L Cutland¹⁵, Linda O Eckert⁷, Sonali Kochhar¹⁶, Azucena Bardají¹⁷; Brighton Collaboration Congenital Microcephaly Working Group

Affiliations

¹ Health Partners Institute for Education and Research, United States.
² Baylor College of Medicine, United States.
³ Children's Hospital of Eastern Ontario, Canada.
⁴ Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network and Robinson Research Institute and School of Medicine, University of Adelaide, South Adelaide, Australia.
⁵ Department of Population Medicine, Harvard Medical School & Harvard Pilgrim Health, United States.
⁶ Department of Obstetrics and Gynecology, University of Washington, School of Medicine, Seattle, WA, United States.
⁷ St. Georges Vaccine Institute, Institute of Infection & Immunity, St. Georges University of London, London, UK.
⁸ Kaiser Permanente Vaccine Study Centre, Oakland, CA, United States.
⁹ Rutgers New Jersey Medical School, Newark, NJ, United States.
¹⁰ Department of Paediatrics and Child Health, Aga Khan University, Pakistan.
¹¹ Kelly Government Solutions (KGS), Contractor to DAIDS/NIAID/NIH, Rockville, United States.
¹² National Institutes of Health/National Institute of Allergy and Infectious Disease, United States.
¹³ Institute of Child Health & Department of Paediatrics, University of Nigeria Teaching Hospital, Enugu, Nigeria.
¹⁴ Sanofi Pasteur, Global Pharmacovigilance, Sanofi Pasteur, United States.
¹⁵ Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, Department of Science and Technology National Research Foundation, Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
¹⁶ Global Healthcare Consulting, Delhi, India; Erasmus University Medical Center, Rotterdam, The Netherlands.
¹⁷ ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Hospital Clínic - University of Barcelona, Barcelona, Spain. Electronic address: contact@brightoncollaboration.org.

PMID: 29150052
PMCID: PMC5710988
DOI: 10.1016/j.vaccine.2017.01.044

Guideline

Congenital microcephaly: Case definition & guidelines for data collection, analysis, and presentation of safety data after maternal immunisation

Malini DeSilva et al. Vaccine. 2017.

. 2017 Dec 4;35(48 Pt A):6472-6482.

doi: 10.1016/j.vaccine.2017.01.044.

Authors

Affiliations

¹ Health Partners Institute for Education and Research, United States.
² Baylor College of Medicine, United States.
³ Children's Hospital of Eastern Ontario, Canada.
⁴ Vaccinology and Immunology Research Trials Unit, Women's and Children's Health Network and Robinson Research Institute and School of Medicine, University of Adelaide, South Adelaide, Australia.
⁵ Department of Population Medicine, Harvard Medical School & Harvard Pilgrim Health, United States.
⁶ Department of Obstetrics and Gynecology, University of Washington, School of Medicine, Seattle, WA, United States.
⁷ St. Georges Vaccine Institute, Institute of Infection & Immunity, St. Georges University of London, London, UK.
⁸ Kaiser Permanente Vaccine Study Centre, Oakland, CA, United States.
⁹ Rutgers New Jersey Medical School, Newark, NJ, United States.
¹⁰ Department of Paediatrics and Child Health, Aga Khan University, Pakistan.
¹¹ Kelly Government Solutions (KGS), Contractor to DAIDS/NIAID/NIH, Rockville, United States.
¹² National Institutes of Health/National Institute of Allergy and Infectious Disease, United States.
¹³ Institute of Child Health & Department of Paediatrics, University of Nigeria Teaching Hospital, Enugu, Nigeria.
¹⁴ Sanofi Pasteur, Global Pharmacovigilance, Sanofi Pasteur, United States.
¹⁵ Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Johannesburg, Department of Science and Technology National Research Foundation, Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
¹⁶ Global Healthcare Consulting, Delhi, India; Erasmus University Medical Center, Rotterdam, The Netherlands.
¹⁷ ISGlobal, Barcelona Ctr. Int. Health Res. (CRESIB), Hospital Clínic - University of Barcelona, Barcelona, Spain. Electronic address: contact@brightoncollaboration.org.

PMID: 29150052
PMCID: PMC5710988
DOI: 10.1016/j.vaccine.2017.01.044

No abstract available

Keywords: Adverse event; Brighton Collaboration; Case definition; Congenital microcephaly; GAIA; Guidelines; Immunisation.

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Figures

**Fig. 1**
Measuring Head Circumference (image reproduced from reference CDC’s response to Zika [56]).

**Fig. 2**
Reproduced from reference . The level of the cross-section through the fetal head for correct measurement (A). The image (B) is well magnified, the head is horizontal, oval in shape and symmetrical. The landmarks are seen with a centrally positioned and continuous midline falx cerebri (1), the midline echo is broken anteriorly at one-third of its length by the cavum septi pellucidi (2) and the thalami are located symmetrically (3). Callipers, are placed so that their intersection is on the outer border of the bones (C). When using the ellipse facility this should run along the outer border of the skull (D).

See this image and copyright information in PMC

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References

1. Division of Birth Defects and Developmental Disabilities N, Centers for Disease Control and Prevention. Facts about microcephaly; 2016.
1. Organization WH. Assessment of infants with microcephaly in the context of Zika virus; 2016.
1. National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) CfDCaP. Congenital microcephaly case definitions; 2016.
1. Opitz J.M., Holt M.C. Microcephaly: general considerations and aids to nosology. J Craniofac Genet Dev Biol. 1990;10:175–204. - PubMed
1. Swaiman KF AS, Ferriero DM, Schor NF. Swaiman’s pediatric neurology: principles and practice; 2012.

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[1] Division of Birth Defects and Developmental Disabilities N, Centers for Disease Control and Prevention. Facts about microcephaly; 2016.

[2] Division of Birth Defects and Developmental Disabilities N, Centers for Disease Control and Prevention. Facts about microcephaly; 2016.

[3] Organization WH. Assessment of infants with microcephaly in the context of Zika virus; 2016.

[4] Organization WH. Assessment of infants with microcephaly in the context of Zika virus; 2016.

[5] National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) CfDCaP. Congenital microcephaly case definitions; 2016.

[6] National Center for Emerging and Zoonotic Infectious Diseases (NCEZID) CfDCaP. Congenital microcephaly case definitions; 2016.

[7] Opitz J.M., Holt M.C. Microcephaly: general considerations and aids to nosology. J Craniofac Genet Dev Biol. 1990;10:175–204. - PubMed

[8] Opitz J.M., Holt M.C. Microcephaly: general considerations and aids to nosology. J Craniofac Genet Dev Biol. 1990;10:175–204. - PubMed

[9] Swaiman KF AS, Ferriero DM, Schor NF. Swaiman’s pediatric neurology: principles and practice; 2012.

[10] Swaiman KF AS, Ferriero DM, Schor NF. Swaiman’s pediatric neurology: principles and practice; 2012.

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Congenital microcephaly: Case definition & guidelines for data collection, analysis, and presentation of safety data after maternal immunisation

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Congenital microcephaly: Case definition & guidelines for data collection, analysis, and presentation of safety data after maternal immunisation

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