All abstracts were screened for possible reports of congenital microcephaly following maternal immunisation. official website and that any information you provide is encrypted Nine articles with potentially relevant material were reviewed in more detail, in order to identify studies using case definitions or, in their absence, providing clinical descriptions of the case material. While a number of genetic, metabolic, environmental, and infectious insults can disturb brain growth and cause microcephaly, no etiology is identified in up to 40% of cases. The other 25 patients (62.5%) showed disproportionate microcephaly, with height and/or weight in the normal range for sex and age. When microcephaly is present before or at birth, it is called . Appendix ASupplementary data associated with this article can be found, in the online version, at https://doi.org/10.1016/j.vaccine.2017.01.044. The current study was designed to investigate co-occurrence of absolute/relative microcephaly, absolute/relative macrocephaly and congenital nervous system disorders or neurological syndromes with symptoms visible since infancy, based on fundamental data acquired during the admission procedure at a neurological rehabilitation ward for children and adolescents. Swelling at or near injection site: case definition and guidelines for collection, analysis and presentation of immunization safety data. and transmitted securely. Cox J, Jackson AP, Bond J, Woods CG. Cytomegalovirus, when symptomatic, has a 20% microcephaly rate, which is the strongest predictive value for future neurocognitive deficits. Prognosis depends on the underlying cause of microcephaly. While the majority of cases of microcephaly are congenital, there are cases where insults occur postnatally that affect brain development. Whole exome sequencing is becoming more widely available and is being studied in the evaluation of microcephaly. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (, head circumference, microcephaly, syndromes, genetic abnormalities, neuroimaging, Zika virus. Silveira C.M., Caceres V.M., Dutra M.G., Lopes-Camelo J., Castilla E.E. HHS Vulnerability Disclosure, Help OR (microcephaly or microencephaly or small head).sh,kw. Some have a narrow, sloping forehead; mild seizures; problems with attention or behavior; or short stature compared to others in their family. Underreporting and varying study definitions make it difficult to track and report a true incidence of microcephaly. However, the mean and standard deviation should also be provided. The intent of this document is to provide a standardized case definition and guidelines to improve reliability and comparability of data collected in clinical trials and observational studies and to provide a standardized framework for consistently monitoring the safety of vaccines currently recommended during pregnancy or available to women of reproductive age. Analysis may also include other characteristics like qualitative patterns of criteria defining the event. The authors are grateful for the support and helpful comments provided by the Brighton Collaboration and the reference group (see https://brightoncollaboration.org/public/what-we-do/setting-standards/case-definitions/groups.html for reviewers), as well as other experts consulted as part of the process (Elyse Kharbanda). Safety of MF59-adjuvanted A/H1N1 influenza vaccine in pregnancy: a comparative cohort study. It can result from infections or very rare genetic syndromes. It may be present at birth or develop postnatally. Primary microcephaly: Do all roads lead to Rome? Microcephaly can be present at birth or it may develop in the first few years of life. Microcephaly is a lifelong condition with no known cure. Congenital microcephaly, also referred to as primary microcephaly due to its presence in utero or at birth, is a descriptive term for a structural defect in which a fetus or infant's head (cranium) circumference is smaller than expected when compared to other fetuses or infants of the same gestational age, sex and ethnic background. This may only be possible to determine in retrospect. The standards are very similar to those of the WHO MGRS, are readily available online and are endorsed by the International Society for Ultrasonography in Obstetrics and Gynecology [60], [63]. Faheem M., Naseer M.I., Rasool M., Chaudhary A.G., Kumosani T.A., Ilyas A.M., Pushparaj M.R., Ahmed F., Algahtani H.A., Al-Qahtani M.H., et al. A thorough and detailed history and physical examination may suggest a diagnosis or further testing. Clinical description of signs and symptoms of congenital microcephaly, and if there was medical confirmation of the event (i.e., patient seen by physician). Isolated microcephaly caused by metabolic disorders with no other signs is rare, with three noted exceptions: maternal PKU, Amish lethal microcephaly, and phosphoglycerate dehydrogenase deficiency. INTERGROWTH-21st measurements were obtained before 12 hours of life and WHO measurements were obtained before 24 hours of life). 1). Conclusion: Head circumference showed highly . Fig. Garland S.M., Ault K.A., Gall S.A., Paavonen J., Sings H.L., Ciprero K.L. Passemard S, Titomanlio L, Elmaleh M, Afenjar A, Alessandri JL, Andria G, de Proportional microcephaly occurs when the head circumference is >23 SD below the mean in addition to height and weight being at similar percentiles. Basit S., Al-Harbi K.M., Alhijji S.A.M., Albalawi A.M., Alharby S., Eldardear A., Samman M.I. Studies suggest that the proteins produced from many of these genes help regulate cell division in the developing brain. All reported events of congenital microcephaly should be presented according to the categories listed in guideline 30. Den Hollander N.S., Wessels M.W., Los F.J., Ursem N.T., Niermeijer M.F., Wladimiroff J.W. The parents of an individual with an autosomal recessive condition each carry one copy of the mutated gene, but they typically do not show signs and symptoms of the condition. Kaindl AM, Passemard S, Kumar P, Kraemer N, Issa L, Zwirner A, Gerard B, Specific focus should be on maternal medical conditions associated with increased risk for having an infant with congenital microcephaly (e.g., anorexia nervosa). For example, microcephaly can be stratified into genetic causes, those associated with syndromes or a known constellation of symptoms, secondary to insults to neuronal development including toxins, metabolites, and infections, and proportional microcephaly. Vaccination against H1N1 influenza with Pandemrix((R)) during pregnancy and delivery outcome: a Swedish register study. Pasternak B., Svanstrom H., Molgaard-Nielsen D., Krause T.G., Emborg H.D., Melbye M. Risk of adverse fetal outcomes following administration of a pandemic influenza A(H1N1) vaccine during pregnancy. serology to identify infections) or specialty consultations (e.g. Genetic abnormalities, syndromes, metabolic disorders, teratogens, infections, prenatal, perinatal, and postnatal injuries can cause both congenital and postnatal microcephaly. Soares de Arajo J.S., Regis C.T., Gomes R.G.S., Tavares T.R., Rocha dos Santos C., Assuncao P.M., Nbrega R.V., Alves Pinto D.d.F., Bezerra B.V.D., da Silva Mattos S. Microcephaly in north-east Brazil: A retrospective study on neonates born between 2012 and 2015. Cytomegalovirus is the most recognized and common TORCH infection causing microcephaly [26,27]. SPORTS. 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). Georges Vaccine Institute, Institute of Infection & Immunity, St. Georges University of London, London, UK, hKaiser Permanente Vaccine Study Centre, Oakland, CA, United States, iRutgers New Jersey Medical School, Newark, NJ, United States, jDepartment of Paediatrics and Child Health, Aga Khan University, Pakistan, kKelly Government Solutions (KGS), Contractor to DAIDS/NIAID/NIH, Rockville, United States, lNational Institutes of Health/National Institute of Allergy and Infectious Disease, United States, mInstitute of Child Health & Department of Paediatrics, University of Nigeria Teaching Hospital, Enugu, Nigeria, nSanofi Pasteur, Global Pharmacovigilance, Sanofi Pasteur, United States, oMedical 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, pGlobal Healthcare Consulting, Delhi, India, rErasmus University Medical Center, Rotterdam, The Netherlands, qISGlobal, Barcelona Ctr. Another proposed cause is the release of genetically . A. Postnatally diagnosed Congenital Microcephaly Case Definition, B. Prenatally diagnosed Congenital Microcephaly Case Definition. Mutations in any of the genes associated with MCPH impair early brain development. Mutations in centrosome components that. Epub 2009 Oct 21. Teratogenic exposures. In 20152016, reports emerged from Brazil about a significant rise in the rates of microcephaly, up to 48% of all live births. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. Primer on Data Quality in Birth Defects Surveillance, 7.1 Why data quality matters; A surveillance scenario, 7.4 General good data strategies and practices, 7.5 Key Characteristics of Data Quality in Public Health Surveillance, 7.6 Quality Data come from Quality Processes, 7.8 Quality and waste in surveillance, Congenital Anomalies of the Nervous System, Congenital Anomalies of the Nervous System: Microcephaly, Congenital Anomalies of the Ear: Microtia/Anotia, Congenital Anomalies of the Digestive System, Oesophageal Atresia/Tracheo-Oesophageal Fistula, Congenital Anomalies of Genital and Urinary Organs, Congenital Anomalies and Deformations of the Musculoskeletal System: Talipes Equinovarus, Longitudinal Preaxial (Tibia, Radius, First Ray), Longitudinal Axial Defects Split Hand and Foot, Longitudinal Postaxial (Fibula, Ulna, Fifth Ray), Chromosomal Abnormalities: Trisomy 21 (Down Syndrome), Congenital anomalies of the nervous system, Congenital anomalies of the digestive system, Congenital anomalies of the genital and urinary organs, Congenital anomalies and deformations of the musculoskeletal system, Birth Defects Surveillance Course Overview, Module 1: Introduction to Congenital Anomalies Surveillance, 1.1 Public Health and Surveillance of Congenital Anomalies, Module 2: Introduction to Planning Activities and Tools, Module 3: Introduction to Surveillance Approaches, 3.8 Description Formats for Congenital Anomalies, Module 4: Introduction to Diagnosis of Selected Congenital Anomalies, 4.1 External Major Congenital Anomalies for Monitoring, 5.1 International Classification of Diseases, 5.3 Personnel Responsible for Diagnosis and Coding, International Clearinghouse for Birth Defects Surveillance and Research (ICBDSR), U.S. Department of Health & Human Services. Licensee MDPI, Basel, Switzerland. 2009 Nov;25(11):501-10. doi: 10.1016/j.tig.2009.09.011. Roberts E, Hampshire DJ, Pattison L, Springell K, Jafri H, Corry P, Mannon J, M, Gressens P, Gerard B, Verloes A. Pardi N., Hogan M.J., Pelc R.S., Muramatsu H., Andersen H., DeMaso C.R., Dowd K.A., Sutherland L.L., Scearce R.M., Parks R., et al. It should be noted that in addition to microcephaly, Zika virus infection has been associated with other neurologic and brain abnormalities, which can be found in the absence of microcephaly [15], [16], [17], [18], [19], [20]. As of December 2016, 17 genes (MCPH1-17) have been identified that are associated with genetic causes of congenital microcephaly. To diagnose microcephaly after birth, a healthcare provider will measure the distance around a newborn baby's head, also called the head circumference, during a physical exam. There is no uniformly accepted definition of congenital microcephaly as an adverse event in a fetus or infant following maternal immunisation. Microcephaly is usually defined as a head circumference (HC) more than 2 SDs below the mean for age and gender. It can also provide means for predicting a prognosis and planning early interventions that can aid patients and their families. Head circumference is the distance around the widest part of the head, measured by placing a measuring tape above the eyebrows and ears and around the back of the head. A, editors. Maternal immunisation history (i.e., previous immunisations and any adverse event following immunisation (AEFI)), in particular occurrence of congenital microcephaly in a prior pregnancy following previous maternal immunisation. 22;73(12):962-9. doi: 10.1212/WNL.0b013e3181b8799a. If the baby has proportionate microcephaly - and is just born small - then it's possible that the brain development could catch up, although "a lot of questions still need to be answered", Nielsen-Saines said. Proportionate (symmetric) microcephaly describes a child with a head circumference, height and weight that are similarly below average for age. Ideally, dating is based on or confirmed by a first trimester ultrasound scan using crown-rump length for measurement. When microcephaly develops later in infancy or childhood, it is called . Microcephaly: general considerations and aids to nosology. Outcomes are highly variable and depend on the underlying cause. Data on congenital microcephaly obtained from subjects receiving a vaccine should be compared with those obtained from an appropriately selected and documented control group(s) to assess background rates in non-exposed populations, and should be analysed by study arm and dose where possible, e.g., in prospective clinical trials. Ensure that the skull is oval, symmetrical and visible all the way around on the ultrasound monitor. The findings, opinions and assertions contained in this consensus document are those of the individual scientific professional members of the working group. How do you calculate microcephaly? Adam MP, Everman DB, Mirzaa GM, Pagon RA, Wallace SE, Bean LJH, Gripp KW, Amemiya Before ], and expiration date) and number of dose if part of a series of immunisations against the same disease). Hashmi J.A., Al-Harbi K.M., Ramzan K., Albalawi A.M., Mehmood A., Samman M.I., Basit S. A novel splice-site mutation in the ASPM gene underlies autosomal recessive microcephaly. For infants: Gestational age and birth weight, birth length and head circumference. In addition to congenital microcephaly, studies have also shown a mechanism in which Zika virus could contribute to postnatal head growth, independent of the time of infection (congenital vs. postnatal). Primary microcephaly: do all roads lead to Rome? MAIL. GA assessed based on certain LMP with confirmatory 1st trimester or 2nd trimester US scan, IUI, or embryo transfer date, Live birth, stillbirth, or spontaneous or therapeutic abortion of at least 24weeks of GA, Measured >36h and up to 6weeks after birth or end of pregnancy with no apparent post-natal insult resulting in microcephaly, GA assessed based on uncertain LMP with 2nd trimester US scan, Take into account the variability in this period based on molding of the head, Measured up to 6weeks after birth or end of pregnancy with no apparent post-natal insult resulting in microcephaly, GA based on LMP without confirmatory 1st or 2nd trimester ultrasound, Live birth, stillbirth, or spontaneous or therapeutic abortion, Case meets criteria for microcephaly using a validated algorithm: 1 inpatient diagnosis OR 2 outpatient diagnoses OR 1 outpatient diagnosis AND death in first year using the following diagnostic codes ICD-9-CM code 742.1 or ICD-10-CM code Q02, Diagnosis of congenital microcephaly based on physical inspection without HC measurement. Exposures other than maternal immunisation during pregnancy (e.g., maternal medications, infections, environmental) considered potentially relevant to the reported event. 10.1016/j.pneurobio.2009.11.002. The size of the cranial vault is an indicator of the size of the underlying brain. about navigating our updated article layout. Microcephaly is a cranial vault that is smaller than normal for the baby's sex and gestational age at birth (Fig. Take and report photographs: Show full face and body photographs, if allowed; can be crucial for review. 22 Data were analyzed with Stata 14.0 software (StataCorp, College Station, TX). will also be available for a limited time. Table 1 is a reproduced table which provides an extensive list of genetic disorders including metabolic disorders, perinatal brain injury due to maternal disease or teratogen exposure (including in utero drug or toxin exposure and infectious agents such as toxoplasmosis, rubella, cytomegalovirus, Herpes simplex, syphilis, parvovirus B19, and varicella [TORCH infections]) during pregnancy [22]. Following the process described in the overview paper [54] as well as on the Brighton Collaboration Website http://www.brightoncollaboration.org/internet/en/index/process.html, the Brighton Collaboration Congenital Microcephaly Working Group was formed in 2016 and included members with background in clinical medicine, paediatrics, neonatology, neurology, vaccinology, research, public health and industry. Neuroimaging with magnetic resonance imaging (MRI) is often the first diagnostic test in evaluating children with microcephaly. General recommendations for optimal HC measurement in a fetus with normal intracranial anatomy include [59]: Accurate gestational age determination is vital when determining congenital microcephaly based on prenatal ultrasound scan. In: 1485 0 obj <>/Filter/FlateDecode/ID[<914E1EBF81B29A40993D95959BD5F41B><27C7D42E02B6C54CA6848DEF6DD80099>]/Index[1472 27]/Info 1471 0 R/Length 82/Prev 1420496/Root 1473 0 R/Size 1499/Type/XRef/W[1 3 1]>>stream The https:// ensures that you are connecting to the Department of Pediatrics, Vanderbilt University School of Medicine, 8161 Doctors Office Tower, 2200 Childrens Way, Nashville, TN 37232, USA; Received 2016 Nov 10; Accepted 2017 May 31. Zheteyeva Y., Moro P.L., Yue X., Broder K. Safety of meningococcal polysaccharide-protein conjugate vaccine in pregnancy: a review of the Vaccine Adverse Event Reporting System. SEARCH. We have also included radiology findings, specifically fetal ultrasound examination results, for use in the prenatal definition for congenital microcephaly. We take your privacy seriously. 8600 Rockville Pike 2010 Mar;90(3):363-83. doi: Whole-exome sequencing is a powerful approach for establishing the etiological diagnosis in patients with intellectual disability and microcephaly. Please note that the occiput may not always be easily recognizable, particularly if there is significant molding of the infants head. These guidelines represent a desirable standard for the presentation and publication of data on congenital microcephaly following maternal immunisation to allow for comparability of data, and are recommended as an addition to data presented for the specific study question and setting. Prenatal head growth and child neuropsychological development at age 14 months. Whichever tape measure is used, the metric system should be used and marked by 0.1cm increments. Findings noted at birth included severe symmetrical growth retardation with proportionate microcephaly, prominent nose, small jaw and short digits with bilateral fifth finger clinodactyly. A fetal HC measurement can be obtained starting at approximately 14weeks estimated gestational age. :_ BBT Autosomal recessive primary microcephaly (often shortened to MCPH, which stands for "microcephaly primary hereditary") is a condition in which infants are born with a very small head and a small brain. de Onis M., Garza C., Onyango A.W., Rolland-Cachera M.F. 12. What are the different ways a genetic condition can be inherited? Head circumference will be small do not code as microcephaly. They help us to know which pages are the most and least popular and see how visitors move around the site. The term "microcephaly" comes from the Greek words for "small head.". Findings from the literature search were for the most part single case reports, in which the terminology was very inconsistent with no standard case definitions. OR (maternal vaccin or maternal immunisation or maternal immunisation).mp. de Fatima Vasco Aragao M., van der Linden V., Brainer-Lima A.M., Coeli R.R., Rocha M.A., Sobral da Silva P. Clinical features and neuroimaging (CT and MRI) findings in presumed Zika virus related congenital infection and microcephaly: retrospective case series study. 27 To attempt to isolate the disproportionate phenotype, we conducted a sensitivity analysis in a subcohort excluding newborns who were small for . 2013 ford edge door code reset; city of berkeley after school programs. Acquired Microcephaly: Causes, Patterns, Motor and IQ Effects, and Associated Growth Changes. Head size is an important measurement to monitor a child's brain growth. Missouri birth defects 19951999. However, the frequencies of newborns with microcephaly with a very low length and disproportionate microcephaly were higher among the neonates of the epidemic period with brain abnormalities and positive for Zika virus. Severe, Ye Y., Cho M.T., Retterer K., Alexander N., Ben-Omran T., Al-Mureikhi M., Cristian I., Wheeler P.G., Crain C., Zand D., et al. Specifically, the findings and conclusions in this paper are those of the authors and do not necessarily represent the views of their respective institutions. Accessibility Detailed information about the severity of the event should always be recorded, as specified by the data collection guidelines. Child growth standards: head circumference-for-age; 2016. The additional guidelines have been developed as guidance for the collection of information to allow for a more comprehensive understanding of congenital microcephaly following maternal immunisation. Verloes A, Mani S, Gressens P. Many roads lead to primary autosomal recessive official website and that any information you provide is encrypted In this way it is hoped that all possible cases of congenital microcephaly can be captured. It needs to be emphasised that the grading of definition levels is used to determine diagnostic certainty, not the clinical severity of an event. The guidelines are not intended to guide the primary reporting of congenital microcephaly to a surveillance system or study monitor. Guidelines 142 below have been developed to address data elements for the collection of adverse event information as specified in general drug safety guidelines by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use [66], and the form for reporting of drug adverse events by the Council for International Organizations of Medical Sciences [67]. Safety of tetanus toxoid in pregnant women: a hospital-based case-control study of congenital anomalies. Studies evaluating population level prevalence are limited as most available reports are based on small case numbers and focus on discrete populations such as individuals with cerebral palsy or musculoskeletal defects, making these studies poorly generalizable. Does a small head always mean microcephaly? Events that meet the case definition should be classified according to the levels of diagnostic certainty as specified in the case definition. If after the first trimester, gestational age has not yet been confirmed and congenital microcephaly is suspected, HC should not be used to determine gestational age [60]. 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