Over the past few decades, the prognosis of neonatal seizures has experienced considerable enhancement due to the improvement in neonatal and infant care. The mortality rate of neonatal seizures has fallen from 40% to 20%, and the relationship between electro encephalogram (EEG) and prognosis has become quite clear. The underlying cause of seizures is a major determinant of the outcome of the disease. For example, patients with secondary seizures and hypoxic-ischemic encephalopathy have only 50% chance of normal development and total recovery, while newborns with secondary seizures and subarachnoid hemorrhage or better hypocalcemia have higher chances of recovery. Searches were conducted by two independent researchers in international (PubMed, Web of Science, Scopus, and Google Scholar) and national (SID and Magiran) databases for related studies from the inception of the databases to September 2017 (without time limitation) in English and Persian languages. It is possible to achieve accurate diagnosis through checking the history before birth and performing a thorough physical examination in some rare cases. Depending on the case, tests or additional actions can be done. EEG is the primary means for diagnosis and may exhibit paroxysmal activity in the difference between seizures or may produce electrographic seizures in cases where seizure is hidden or latent. One of the most important points in the treatment of neonatal seizures is the diagnosis of underlying cause (such as hypoglycemia, meningitis, drug deprivation, and trauma) because such diagnosis facilitates different approaches to control neonatal seizures. Most experts agree to control all clinical and electrographic seizures. Some others focus merely on clinical seizures. Most centers prefer the first approach. An important point before starting an anticonvulsant drug is to decide if the patient needs intravenous and luteinizing treatment with an initial bolus dose, or it can be easy to start treatment with a prescription for a long-acting medication based on the severity of seizure, duration, and frequency.
Epilepsy is a chronic neurological disorder which is caused by various factors which may vary according to the age of patients which results in asynchronization of neurons. Cognitive functional impairment is mostly seen in epileptic patients compared to the general population, and the degree of its impairment varies from one another according to the epilepsy syndrome. Behavioral changes are more seen in epileptic people and people with drug-resistant epilepsy, frequent seizures, and associated neurological or mental abnormalities. In children and adults, many data suggest a correlation between behavior/cognition and some other specific epilepsy syndromes. The major predictors of such behavioral changes in children with epilepsy are epilepsy itself, treatment, the underlying structural lesion, and epilepsy treatment.
Over the past few decades, the prognosis of neonatal seizures has experienced considerable enhancement due to the improvement in neonatal and infant care. The mortality rate of neonatal seizures has fallen from 40% to 20%, and the relationship between electro encephalogram (EEG) and prognosis has become quite clear. The underlying cause of seizures is a major determinant of the outcome of the disease. For example, patients with secondary seizures and hypoxic-ischemic encephalopathy have only 50% chance of normal development and total recovery, while newborns with secondary seizures and subarachnoid hemorrhage or better hypocalcemia have higher chances of recovery. Searches were conducted by two independent researchers in international (PubMed, Web of Science, Scopus, and Google Scholar) and national (SID and Magiran) databases for related studies from the inception of the databases to September 2017 (without time limitation) in English and Persian languages. It is possible to achieve accurate diagnosis through checking the history before birth and performing a thorough physical examination in some rare cases. Depending on the case, tests or additional actions can be done. EEG is the primary means for diagnosis and may exhibit paroxysmal activity in the difference between seizures or may produce electrographic seizures in cases where seizure is hidden or latent. One of the most important points in the treatment of neonatal seizures is the diagnosis of underlying cause (such as hypoglycemia, meningitis, drug deprivation, and trauma) because such diagnosis facilitates different approaches to control neonatal seizures. Most experts agree to control all clinical and electrographic seizures. Some others focus merely on clinical seizures. Most centers prefer the first approach. An important point before starting an anticonvulsant drug is to decide if the patient needs intravenous and luteinizing treatment with an initial bolus dose, or it can be easy to start treatment with a prescription for a long-acting medication based on the severity of seizure, duration, and frequency.
Epilepsy is a chronic neurological disorder which is caused by various factors which may vary according to the age of patients which results in asynchronization of neurons. Cognitive functional impairment is mostly seen in epileptic patients compared to the general population, and the degree of its impairment varies from one another according to the epilepsy syndrome. Behavioral changes are more seen in epileptic people and people with drug-resistant epilepsy, frequent seizures, and associated neurological or mental abnormalities. In children and adults, many data suggest a correlation between behavior/cognition and some other specific epilepsy syndromes. The major predictors of such behavioral changes in children with epilepsy are epilepsy itself, treatment, the underlying structural lesion, and epilepsy treatment.
Clinical, ethical and legal considerations in the treatment of newborns 2008Dominique Gross
Non-ketotic hyperglycinaemia (NKH) is a devastating neurometabolic disorder leading, in its classical form, to early death or severe disability and poor quality of life in survivors. Affected neonates may need ventilatory support during a short period of respiratory depression. The transient dependence on ventilation dictates urgency in decision-making regarding withdrawal of therapy.
The occurrence of patients with apparent transient forms of the disease, albeit rare, adds uncertainty to the prediction of clinical outcome and dictates that the current practice of withholding or withdrawing therapy in these neonates be reviewed. Both bioethics and law take the view that treatment decisions should be based on the best interests of the patient.
The medical-ethics approach is based on the principles of non-maleficence, beneficence, autonomy and justice. The law relating to withholding or withdrawing life-sustaining treatment is complex and varies between jurisdictions. Physicians treating newborns with NKH need to provide families with accurate and complete information regarding the disease and the relative probability of possible outcomes of the neonatal presentation and to explore the extent to which family members are willing to take part in the decision making process. Cultural and religious attitudes, which may potentially clash with bioethical and juridical principles, need to be considered.
2008 Elsevier Inc
Summary Report: "Mental Health Throughout Life"
Herrenhausen Conference on Mental Illnesses, Hanover, April 3-5, 2013
Mechanisms of vulnerability for mental illnesses over lifetime were the focus of the Volkswagen Foundation’s second Herrenhausen Conference. Concentrating on particularly sensitive and susceptible phases of mental development, renowned experts shared their latest research and insights into risk for and resilience against mental illnesses. Building on this material, in a concluding Session new approaches for improving mental health and treating mental disorders were highlighted.
el mundo desarrollado tiene un mayor indice de epilepsia, Nuevos conocimientos sobre las causas y consecuencias de la epilepsia en los países en desarrollo ofrecen oportunidad para la prevención y / o tratamiento mejorado, que se complementan con las directrices publicadas recientemente epilepsia cuidado para su uso en este entorno
A 100 years ago, when neonatal intensive care units (NICUs) started to be well established, the race never stopped trying to add new regimens to improve neonatal survival. On the other hand, long term sequelae of medications used at NICUs were usually not sufficiently studied and left mostly unnoticed for many years by neonatologists. Here we are trying to understand & & shed the light on some of these sequelae in a trial avoid those sequelae while working on NICU candidates.
Lecture given at the 6th Conference for Nile Basin Pediatrics 2-5 December 2015, Hurgada, Egypt
Right Temporal Lobe Meningioma presenting as postpartum depression: A case re...Apollo Hospitals
Meningiomas are tumors which arise from arachnoid cells and can occur both in the brain and spinal cord. Meningiomas can present with psychiatric symptoms (such as depression, anxiety disorders, or personality changes) in the absence of any neurologic signs or symptoms.
CPG adaptation project for Childhood CSE.
(Dissemination and Implementation Phase)
Training session for Pediatrics resident at King Khalid University Hospital, King Saud University Medical City
DSM proposal for Sensory Processing Disorder. Of interest to those who want to know more in general, or know more about SPD as it compares to ASD or Misophonia.
Clinical, ethical and legal considerations in the treatment of newborns 2008Dominique Gross
Non-ketotic hyperglycinaemia (NKH) is a devastating neurometabolic disorder leading, in its classical form, to early death or severe disability and poor quality of life in survivors. Affected neonates may need ventilatory support during a short period of respiratory depression. The transient dependence on ventilation dictates urgency in decision-making regarding withdrawal of therapy.
The occurrence of patients with apparent transient forms of the disease, albeit rare, adds uncertainty to the prediction of clinical outcome and dictates that the current practice of withholding or withdrawing therapy in these neonates be reviewed. Both bioethics and law take the view that treatment decisions should be based on the best interests of the patient.
The medical-ethics approach is based on the principles of non-maleficence, beneficence, autonomy and justice. The law relating to withholding or withdrawing life-sustaining treatment is complex and varies between jurisdictions. Physicians treating newborns with NKH need to provide families with accurate and complete information regarding the disease and the relative probability of possible outcomes of the neonatal presentation and to explore the extent to which family members are willing to take part in the decision making process. Cultural and religious attitudes, which may potentially clash with bioethical and juridical principles, need to be considered.
2008 Elsevier Inc
Summary Report: "Mental Health Throughout Life"
Herrenhausen Conference on Mental Illnesses, Hanover, April 3-5, 2013
Mechanisms of vulnerability for mental illnesses over lifetime were the focus of the Volkswagen Foundation’s second Herrenhausen Conference. Concentrating on particularly sensitive and susceptible phases of mental development, renowned experts shared their latest research and insights into risk for and resilience against mental illnesses. Building on this material, in a concluding Session new approaches for improving mental health and treating mental disorders were highlighted.
el mundo desarrollado tiene un mayor indice de epilepsia, Nuevos conocimientos sobre las causas y consecuencias de la epilepsia en los países en desarrollo ofrecen oportunidad para la prevención y / o tratamiento mejorado, que se complementan con las directrices publicadas recientemente epilepsia cuidado para su uso en este entorno
A 100 years ago, when neonatal intensive care units (NICUs) started to be well established, the race never stopped trying to add new regimens to improve neonatal survival. On the other hand, long term sequelae of medications used at NICUs were usually not sufficiently studied and left mostly unnoticed for many years by neonatologists. Here we are trying to understand & & shed the light on some of these sequelae in a trial avoid those sequelae while working on NICU candidates.
Lecture given at the 6th Conference for Nile Basin Pediatrics 2-5 December 2015, Hurgada, Egypt
Right Temporal Lobe Meningioma presenting as postpartum depression: A case re...Apollo Hospitals
Meningiomas are tumors which arise from arachnoid cells and can occur both in the brain and spinal cord. Meningiomas can present with psychiatric symptoms (such as depression, anxiety disorders, or personality changes) in the absence of any neurologic signs or symptoms.
CPG adaptation project for Childhood CSE.
(Dissemination and Implementation Phase)
Training session for Pediatrics resident at King Khalid University Hospital, King Saud University Medical City
DSM proposal for Sensory Processing Disorder. Of interest to those who want to know more in general, or know more about SPD as it compares to ASD or Misophonia.
KNOWLEDGE-BASED FUZZY INFERENCE SYSTEM FOR SEPSIS DIAGNOSISijcsity
In this study, a Fuzzy Inference System is developed to create a knowledge-based for the diagnosis and detection of sepsis using Matlab’s fuzzy logic toolbox. The FIS consists of expert-specified input membership functions, output membership function, and IF-THEN rules. To validate our system, we tested it with the domain (medical) expert knowledge by comparing its performance with at least 10 hypothetical scenarios. The KB-FIS gave good answers in 8/10 scenarios and generated rules for decision support. The answers are qualitatively correct but quantitatively small. The fuzzy inference system designed performs as well as the medical experts under controlled conditions. With the methodology used in this study, it is hoped that it can assist in enhancing the knowledge-base system for proper, effective and early diagnosis and detection of sepsis
Study of Neonatal Outcome with Low Apgar Score in Term Neonatesiosrjce
IOSR Journal of Dental and Medical Sciences is one of the speciality Journal in Dental Science and Medical Science published by International Organization of Scientific Research (IOSR). The Journal publishes papers of the highest scientific merit and widest possible scope work in all areas related to medical and dental science. The Journal welcome review articles, leading medical and clinical research articles, technical notes, case reports and others.
Perioperative Management of the Pediatric Organ Donorasclepiuspdfs
Introduction: For bereaved families, organ donation does not take away from the pain and loss of death, but it does give some meaning at the time and a great deal of comfort later. Each and every family whose child has suffered brain stem death should be offered the chance to donate. When a diagnosis of brain death has been made in a child, it may be possible for organ donation to occur, but it requires optimization of the donor and meticulous planning. There are a number of medical, nursing, ethical, psychological, and administrative issues which must be addressed in the perioperative period to facilitate the procurement of organs in good condition. Aim: This review aims to provide up to date information and provides the clinical pathway used in our tertiary level, university-affiliated children’s hospital for the management of the child in the critical care unit before organ donation, and intraoperative anaesthetic management. Method: This review was prepared using literature and clinical guidelines which were obtained from Medline and EMBASE databases, using the following search terms: Organ donation; intensive care management of organ donor; paediatric; neonatal; transplant outcome; and graft outcome. The focused literature search was carried out in 2017 by the five authors involved in the project. Results: The Society of Critical Care Medicine published consensus based guidelines for donor management in adult patients in 2015. Many of the core critical care principles in this document are similar in infants and children; although there are different considerations with respect to the diagnosis of brain death, consent, and pharmacological management. Full-text papers were employed by the project group to update our clinical pathway for the perioperative management of the infant or child who is a potential organ donor. Providing critical care medical and nursing staff with a pathway may improve communication, confidence, and delivery of care to the deceased child, their family and the graft recipients in this challenging situation.
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
- Video recording of this lecture in English language: https://youtu.be/lK81BzxMqdo
- Video recording of this lecture in Arabic language: https://youtu.be/Ve4P0COk9OI
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
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ARTIFICIAL INTELLIGENCE IN HEALTHCARE.pdfAnujkumaranit
Artificial intelligence (AI) refers to the simulation of human intelligence processes by machines, especially computer systems. It encompasses tasks such as learning, reasoning, problem-solving, perception, and language understanding. AI technologies are revolutionizing various fields, from healthcare to finance, by enabling machines to perform tasks that typically require human intelligence.
How to Give Better Lectures: Some Tips for Doctors
Encefalopatia neonatal
1. Commentary
Neonatal encephalopathy: Case definition & guidelines for data
collection, analysis, and presentation of maternal immunisation
safety data
Erick Sell a,⇑
, Flor M. Munoz b
, Aung Soe c
, Max Wiznitzer d
, Paul T. Heath e
, E.D. Clarke f
, Hans Spiegel g
,
Daphne Sawlwin h
, Maja Šubelj i
, Ilia Tikhonov j
, Khorshid Mohammad k
, Sonali Kochhar l,m,1
,
for The Brighton Collaboration Acute Neonatal Encephalopathy Working Group2
a
Children’s Hospital of Eastern Ontario, Canada
b
Baylor College of Medicine, United States
c
Medway Maritime Hospital, Gillingham, Kent, United Kingdom
d
Rainbow Babies and Children’s Hospital in Cleveland, United States
e
St. Georges Vaccine Institute, Institute of Infection & Immunity, St. Georges, University of London, London, UK
f
Medical Research Unit, Gambia
g
Henry M. Jackson Foundation, Kelly Government Solutions (KGS), Contractor to DAIDS/NIAID/NIH, Rockville, United States
h
Therapeutic Area Lead, Vaccines, Safety Risk Management, Australian QPPVCSL Limited Melbourne, Australia
i
National Institute of Public Health, Ljubljana, Slovenia
j
Sanofi Pasteur, United States
k
University of Calgary, Section of Neonatology, Department of Pediatrics, Foothills Medical Centre, Canada
l
Global Healthcare Consulting, Delhi, India
m
Erasmus University Medical Center, Rotterdam, The Netherlands
a r t i c l e i n f o
Keywords:
Neonatal encephalopathy
Adverse event
Immunisation
Guidelines
Case definition
a b s t r a c t
Ó 2017 Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creative-
commons.org/licenses/by/4.0/).
1. Preamble
1.1. Background on neonatal encephalopathy
To improve comparability of vaccine safety data, the acute
neonatal encephalopathy working group has developed a case
definition and guidelines neonatal encephalopathy applicable in
study settings with different availability of resources, in healthcare
settings that differ by availability of and access to health care, and
in different geographic regions.
The definition and guidelines were developed through group
consensus. They are grounded on both expert opinion and a
systematic literature review related to the assessment of acute
neonatal encephalopathy as an adverse event following immunisa-
tion and to the diagnosis of acute neonatal encephalopathy in
humans.
Encephalopathy is a general term used to define disease,
malfunction or damage of the brain. The major symptom of
encephalopathy is an altered mental state [1]. Defining altered
mental state in the newborn is significantly more challenging than
in the adult and there are no established direct measures to deter-
mine level of consciousness in the newborn. Nevertheless, specific
clinical signs reflecting neurological function correlate with the
overall severity of the encephalopathy. These clinical signs have
been grouped in stages, usually three of them: mild, moderate
and severe as in the Sarnat classification. The Sarnat criteria remain
as the most commonly accepted classification [2,3].
Neonatal encephalopathy has several potential etiologies and
acute hypoxia-ischemia is the most studied cause. Over the years,
the term ‘‘neonatal encephalopathy”, has been used by many as a
http://dx.doi.org/10.1016/j.vaccine.2017.01.045
0264-410X/Ó 2017 Published by Elsevier Ltd.
This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
⇑ Corresponding author.
E-mail address: contact@brightoncollaboration.org (E. Sell).
1
Present address: University of Washington, Seattle USA.
2
Brighton Collaboration homepage: http://www.brightoncollaboration.org.
Vaccine 35 (2017) 6501–6505
Contents lists available at ScienceDirect
Vaccine
journal homepage: www.elsevier.com/locate/vaccine
2. synonym of ‘‘Hypoxic-ischemic encephalopathy”. The reason is
that other etiologies are often reported as a specific diagnosis, as
in the case of inborn errors of metabolism (e.g. non-ketotic hyper-
glycinemia), infections (e.g. meningitis) and other specific causes.
It is therefore imperative to emphasize that many different pro-
cesses leading to neonatal encephalopathy may develop prenatally,
at birth or immediately post-delivery, and result from mainly, but
not exclusively, genetic, metabolic, infectious, and traumatic pro-
cesses. The common denominator in neonatal encephalopathy is
the loss of homeostasis which can lead to abnormal brain function
and potentially to brain structural changes [2–4].
Investigations such as magnetic resonance Imaging and neuro-
physiological technologies such as electroencephalography and
evoked potentials are aids in exploring the severity and prognosis
of neonatal encephalopathy, but are not required for its diagnosis.
MRI brain can be reported normal in 15–30% of cases of
confirmed mild cases (Sarnat 1) of hypoxic ischemic encephalopa-
thy [1,5].
The EEG is the most specific test to confirm and diagnose that a
clinical paroxysm is epileptic in origin [9]. Electrographic
pathological patterns correlate with neonatal seizures during
seizure recording and subtle or subclinical seizures can often only
be diagnosed by EEG monitoring. Once anti-seizure medications
are administered, up to 58% of treated neonates exhibit electro-
clinical uncoupling, in which the clinical signs of their seizures van-
ish despite the persistence of subclinical electrographic seizures [9].
EEG however has important technical limitations in the record-
ing of some epileptic seizures, particularly those originating in
mesial or midline areas of the brain. Also EEG is not always readily
available for recording in the NICU. Amplitude integrated EEG
(aEEG) is becoming widely used by neonatologists. This recording
compresses the time scale of conventional EEG. It has lesser spatial
resolution and is less sensitive for the detection of neonatal sei-
zures compared to long term monitoring by conventional EEG
[10,11]. Abnormalities on the neonatal EEG such as discontinuity
of the background or central sharp waves are not specific and will
vary depending on external factors such as gestational age, body
temperature during therapeutic cooling and medications [7].
Therefore, as per World Health Organization guidelines on
neonatal seizures, the most practical method of diagnosis is the
clinical recognition of neonatal seizures [8].
The Task Force on Neonatal Encephalopathy group on Neonatal
Encephalopathy and Neurological outcome published in 2014 a
comprehensive document defining Neonatal encephalopathy as
‘‘a clinical syndrome in an infant born at or beyond 35 weeks of
gestation, manifested by a subnormal level of consciousness or
seizures, and often accompanied by difficulty with initiating and
maintaining respiration and depression of tone and reflexes” [5].
It was the consensus of our group to replace the word ‘‘conscious-
ness” with the word ‘‘alertness” since the definition of ‘‘conscious-
ness” is more vague. We also considered it necessary to include in
the definition the concept of multiple potential etiologies.
When assessing encephalopathy in a newborn younger than
35 weeks of gestation, normal neurological development may pre-
vent specific behavioral reactions and reflexes to be tested, making
semiology unreliable. Furthermore, the diagnosis of ‘‘encephalopa-
thy of prematurity” is heavily based on neuroanatomical changes
seen on MRI or autopsies rather than acute clinical signs [2,6].
Considering the limitations for diagnosing and timing encepha-
lopathies in the preterm newborn, this review defines Neonatal
encephalopathy as a clinical syndrome presenting with abnormal
functioning of the central nervous system, in the earliest days of
life in an newborn (up to 28 days of life) born at or beyond 35
weeks of gestation, manifested by an abnormal level of alertness
or seizures, and often accompanied by difficulty with initiating
and maintaining respiration and depression of tone that may be
due to a variety of etiologies including hypoxia/ischemia, meta-
bolic disturbance, or infection.
This definition is to be equally applied in vaccinated or unvac-
cinated populations.
1.2. Methods for the development of the case definition and guidelines
for data collection, analysis, and presentation for neonatal
encephalopathy as an adverse events following maternal
immunisation
Following the process described on the Brighton Collaboration
Website http://www.brightoncollaboration.org/internet/en/index/
process.html, the Brighton Collaboration Neonatal Encephalopathy
Working Group was formed in 2016 and included members of clin-
ical, academic, public health and industry background. The compo-
sition of the working and reference group as well as results of the
web-based survey completed by the reference group with
subsequent discussions in the working group can be viewed at:
http://www.brightoncollaboration.org/internet/en/index/working_
groups.html.
To guide the decision-making for the case definition and
guidelines, a literature search was performed using Embase.com
(Medline/PubMed + Embase); ClinicalKey (eBooks); ScienceDirect
(eBooks); StatRef (eBooks) and the Cochrane Library.
Several different research platforms were utilized in this search
for references focused on maternal vaccination and encephalopa-
thies. These platforms included electronic books, systematic
reviews, and other journal literature. The following three search
parameters which included a variety of synonyms were combined;
pregnancy, vaccines, and encephalopathy.
This search resulted in several general book chapters discussing
various types of neonatal encephalopathy. There were no Cochrane
reviews that focused on this topic. The journal literature search
produced 33 results that included subject headings or keywords
for vaccines, pregnancy and encephalopathy. The results were lim-
ited to those published since 2005. The results were further limited
to either reviews or major/prospective clinical studies.
1.3. Temporal versus causal association with maternal immunisation
There are no reports of encephalopathy following immunisation
in the pregnant woman or the newborn. There is hence no uni-
formly accepted definition of Neonatal Encephalopathy following
immunisations. This is a missed opportunity, as data comparability
across trials or surveillance systems would facilitate data interpre-
tation and promote the scientific understanding of the event.
1.4. Periodic review
Similar to all Brighton Collaboration case definitions and guide-
lines, review of the definition with its guidelines is planned on a
regular basis (i.e. every three to five years) or more often if needed.
3. Case definition of neonatal encephalopathy3
For All Levels of Diagnostic Certainty
Newborn (1–28 days) born at or beyond 35 weeks of gestation
Level 1 of diagnostic certainty (Definite)
Abnormal level of alertness or seizures (see footnote 1)
AND
Difficulty with initiating and maintaining respiration
AND
Depression of tone
3
For Seizure definition see Ref. [12].
6502 E. Sell et al. / Vaccine 35 (2017) 6501–6505
3. Level 2 of diagnostic certainty (Probable)
Abnormal level of alertness or seizures
AND
Difficulty with initiating and maintaining respiration
OR
Depression of tone
Level 3 of diagnostic certainty (Possible)
Abnormal level of alertness or seizures without difficulty with
initiating and maintaining respiration nor depression of tone
3. Guidelines for data collection, analysis, and presentation of
generalized acute neonatal encephalopathy as an adverse event
following maternal immunisation
It was the consensus of the Brighton Collaboration Neonatal
Encephalopathy Working Group to recommend the following
guidelines to enable meaningful and standardized collection,
analysis, and presentation of information about Neonatal
encephalopathy. However, implementation of all guidelines might
not be possible in all settings. The availability of information may
vary depending upon resources, geographical region, and whether
the source of information is a prospective clinical trial, a post-
marketing surveillance or epidemiological study, or an individual
report of Neonatal encephalopathy. Also, as explained in more
detail in the overview paper, these guidelines have been devel-
oped by this working group for guidance only, and are not to be
considered a mandatory requirement for data collection, analysis,
or presentation.
3.1. Data collection
These guidelines represent a desirable standard for the collec-
tion of data on availability following maternal immunisation to
allow for comparability of data, and are recommended as an addi-
tion to data collected for the specific study question and setting.
The guidelines are not intended to guide the primary reporting of
Neonatal Encephalopathy to a surveillance system or study moni-
tor. Investigators developing a data collection tool based on these
data collection guidelines also need to refer to the criteria in the
case definition, which are not repeated in these guidelines.
3.1.1. Source of information/reporter
For all cases and/or all study participants, as appropriate, the
following information should be recorded:
(1) Date of report.
(2) Name and contact information of person reporting4
and/or
diagnosing the Neonatal Encephalopathy as specified by coun-
try-specific data protection law.
(3) Name and contact information of the investigator responsi-
ble for the subject, as applicable.
(4) Relation to the patient (e.g., immuniser [clinician, nurse],
family member [indicate relationship], other).
3.1.2. Vaccinee/control
3.1.2.1. Demographics. For all cases and/or all study participants
(including mothers and infants), as appropriate, the following
information should be recorded:
(5) Case/study participant identifiers (e.g. first name initial
followed by last name initial) or code (or in accordance with
country-specific data protection laws).
(6) Date of birth, age, and sex.
(7) For infants: Gestational age and birth weight.
3.1.2.2. Clinical and immunisation history. For all cases and/or all
study participants, as appropriate, the following information
should be recorded:
(8) Past medical history, including hospitalisations, underlying
diseases/disorders, pre-immunisation signs and symptoms
including identification of indicators for, or the absence of,
a history of allergy to vaccines, vaccine components or med-
ications; food allergy; allergic rhinitis; eczema; asthma.
(9) Any medication history (other than treatment for the event
described) prior to, during, and after immunisation
including prescription and non-prescription medication as
well as medication or treatment with long half-life or long
term effect. (e.g. immunoglobulins, blood transfusion and
immunosuppressants).
(10) Immunisation history (i.e. previous immunisations and any
adverse event following immunisation (AEFI)), in particular
occurrence of Acute Neonatal Encephalopathy after a previ-
ous maternal immunisation.
3.1.3. Details of the immunisation
For all cases and/or all study participants, as appropriate, the
following information should be recorded:
(11) Date and time of maternal immunisation(s).
(12) Description of vaccine(s) (name of vaccine, manufacturer, lot
number, dose (e.g. 0.25 mL, 0.5 mL, etc.) and number of dose
if part of a series of immunisations against the same
disease).
(13) The anatomical sites (including left or right side) of all
immunisations (e.g. vaccine A in proximal left lateral thigh,
vaccine B in left deltoid).
(14) Route and method of administration (e.g. intramuscular,
intradermal, subcutaneous, and needle-free (including type
and size), other injection devices).
(15) Needle length and gauge.
3.1.4. The adverse event
(16) For all cases at any level of diagnostic certainty and for
reported events with insufficient evidence, the criteria ful-
filled to meet the case definition should be recorded.
Specifically document:
(17) Clinical description of signs and symptoms of Neonatal
Encephalopathy, and if there was medical confirmation of
the event (i.e. patient seen by physician).
(18) Date/time of onset,5
first observation6
and diagnosis,7
end of
episode8
and final outcome.9
(19) Concurrent signs, symptoms, and diseases.
(20) Measurement/testing
4
If the reporting centre is different from the vaccinating centre, appropriate and
timely communication of the adverse event should occur.
5
The date and/or time of onset is defined as the time post immunisation, when the
first sign or symptom indicative for Neonatal Encephalopathy occurred. This may only
be possible to determine in retrospect.
6
The date and/or time of first observation of the first sign or symptom indicative
for Neonatal Encephalopathy can be used if date/time of onset is not known.
7
The date of diagnosis of an episode is the day post immunisation when the event
met the case definition at any level.
8
The end of an episode is defined as the time the event no longer meets the case
definition at the lowest level of the definition.
9
E.g. recovery to pre-immunisation health status, spontaneous resolution, thera-
peutic intervention, persistence of the event, sequelae, death.
E. Sell et al. / Vaccine 35 (2017) 6501–6505 6503
4. Values and units of routinely measured parameters
(e.g. temperature, blood pressure) – in particular those
indicating the severity of the event;
Method of measurement (e.g. type of thermometer, oral
or other route, duration of measurement, etc.);
Results of laboratory examinations, surgical and/or
pathological findings and diagnoses if present.
(21) Treatment given for Neonatal Encephalopathy, especially
specify what and dosing.
(22) Outcome (see footnote 7) at last observation.
(23) Objective clinical evidence supporting classification of the
event as ‘‘serious”.10
(24) Exposures other than the immunisation 24 h before and
after immunisation (e.g. food, environmental) considered
potentially relevant to the reported event.
3.1.5. Miscellaneous/general
(25) The duration of surveillance for Neonatal encephalopathy
should be predefined based on
Biologic characteristics of the vaccine e.g. live attenuated
versus inactivated component vaccines;
Biologic characteristics of the vaccine-targeted disease;
Biologic characteristics of Neonatal encephalopathy
including patterns identified in previous trials (e.g.
early-phase trials); and
Biologic characteristics of the vaccinee (e.g. nutrition,
underlying disease like immunodepressing illness).
(26) The duration of follow-up reported during the surveillance
period should be predefined likewise. It should aim to con-
tinue to resolution of the event.
(27) Methods of data collection should be consistent within and
between study groups, if applicable.
(28) Follow-up of cases should attempt to verify and complete
the information collected as outlined in data collection
guidelines 1–24.
(29) Investigators of patients with Neonatal encephalopathy
should provide guidance to reporters to optimise the quality
and completeness of information provided.
(30) Reports of Neonatal encephalopathy should be collected
throughout the study period regardless of the time elapsed
between immunisation and the adverse event. If this is not
feasible due to the study design, the study periods during
which safety data are being collected should be clearly
defined.
3.2. Data analysis
The following guidelines represent a desirable standard for
analysis of data on Neonatal encephalopathy to allow for compara-
bility of data, and are recommended as an addition to data anal-
ysed for the specific study question and setting.
(31) Reported events should be classified in one of the following
five categories including the three levels of diagnostic
certainty. Events that meet the case definition should be
classified according to the levels of diagnostic certainty as
specified in the case definition. Events that do not meet
the case definition should be classified in the additional cat-
egories for analysis.
3.2.1. Event classification in 5 categories11
3.2.1.1. Event meets case definition.
(1) Level 1: Criteria as specified in the Neonatal encephalopathy
case definition (Definite)
(2) Level 2: Criteria as specified in the Neonatal encephalopathy
case definition (Possible)
(3) Level 3: Criteria as specified in the Neonatal encephalopathy
case definition (Probable)
3.2.2. Event does not meet case definition
3.2.2.1. Additional categories for analysis.
(4) Reported Neonatal encephalopathy with insufficient
evidence to meet the case definition12
(5) Not a case of Neonatal encephalopathy13
(32) The interval between immunisation and reported Neonatal
Encephalopathy could be defined as the date/time of mater-
nal immunisation to the date/time of onset (see footnote 3)
of the first symptoms and/or signs consistent with the
definition.
(33) The duration of a possible Neonatal Encephalopathy could
be analysed as the interval between the date/time of onset
(see footnote 2) of the first symptoms and/or signs consis-
tent with the definition and the end of episode (see footnote
6) and/or final outcome (see footnote 7). Whatever start and
ending are used, they should be used consistently within
and across study groups.
(34) If more than one measurement of a particular criterion is
taken and recorded, the value corresponding to the greatest
magnitude of the adverse experience could be used as the
basis for analysis. Analysis may also include other character-
istics like qualitative patterns of criteria defining the event.
(35) The distribution of data (as numerator and denominator
data) could be analysed in predefined increments (e.g. mea-
sured values, times), where applicable. Increments specified
above should be used. When only a small number of cases is
presented, the respective values or time course can be pre-
sented individually.
(36) Data on Neonatal Encephalopathy 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 of hypersensitivity in
non-exposed populations, and should be analysed by study
arm and dose where possible, e.g. in prospective clinical
trials.
3.3. Data presentation
These guidelines represent a desirable standard for the
presentation and publication of data on Neonatal Encephalopathy
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. Additionally, it is
10
An AEFI is defined as serious by international standards if it meets one or more of
the following criteria: (1) it results in death, (2) is life-threatening, (3) it requires
inpatient hospitalisation or results in prolongation of existing hospitalisation, (4)
results in persistent or significant disability/incapacity, (5) is a congenital anomaly/
birth defect, and (6) is a medically important event or reaction.
11
To determine the appropriate category, the user should first establish, whether a
reported event meets the criteria for the lowest applicable level of diagnostic
certainty, e.g. Level three. If the lowest applicable level of diagnostic certainty of the
definition is met, and there is evidence that the criteria of the next higher level of
diagnostic certainty are met, the event should be classified in the next category. This
approach should be continued until the highest level of diagnostic certainty for a
given event could be determined.
12
If the evidence available for an event is insufficient because information is
missing, such an event should be categorised as ‘‘Reported Neonatal Encephalopathy
with insufficient evidence to meet the case definition”.
13
An event does not meet the case definition if investigation reveals a negative
finding of a necessary criterion (necessary condition) for diagnosis. Such an event
should be rejected and classified as ‘‘Not a case of Neonatal Encephalopathy”.
6504 E. Sell et al. / Vaccine 35 (2017) 6501–6505
5. recommended to refer to existing general guidelines for the pre-
sentation and publication of randomised controlled trials, system-
atic reviews, and meta-analyses of observational studies in
epidemiology (e.g. statements of Consolidated Standards of
Reporting
Trials (CONSORT), of improving the quality of reports of meta-
analyses of randomised controlled trials (QUORUM), and of meta-
analysis Of Observational Studies in Epidemiology (MOOSE),
respectively).
(37) All reported events of Neonatal Encephalopathy should be
presented according to the categories listed in guideline 31.
(38) Data on Neonatal Encephalopathy events should be pre-
sented in accordance with data collection guidelines 1–24
and data analysis guidelines 31–36
(39) Terms to describe Neonatal Encephalopathy such as ‘‘low-
grade”, ‘‘mild”, ‘‘moderate”, ‘‘high”, ‘‘severe” or ‘‘significant”
are highly subjective, prone to wide interpretation, and
should be avoided, unless clearly defined.
(40) Data should be presented with numerator and denominator
(n/N) (and not only in percentages), if available.
Although immunisation safety surveillance systems denomina-
tor data are usually not readily available, attempts should be made
to identify approximate denominators. The source of the denomi-
nator data should be reported and calculations of estimates be
described (e.g. manufacturer data like total doses distributed,
reporting through Ministry of Health, coverage/population based
data, etc.).
(41) The incidence of cases in the study population should be
presented and clearly identified as such in the text.
(42) If the distribution of data is skewed, median and range are
usually the more appropriate statistical descriptors than a
mean. However, the mean and standard deviation should
also be provided.
(43) Any publication of data on Neonatal encephalopathy should
include a detailed description of the methods used for data
collection and analysis as possible. It is essential to specify:
The study design;
The method, frequency and duration of monitoring for Acute
Neonatal encephalopathy;
The trial profile, indicating participant flow during a study
including drop-outs and withdrawals to indicate the size and
nature of the respective groups under investigation;
The type of surveillance (e.g. passive or active surveillance);
The characteristics of the surveillance system (e.g. population
served, mode of report solicitation);
The search strategy in surveillance databases;
Comparison group(s), if used for analysis;
The instrument of data collection (e.g. standardised question-
naire, diary card, report form);
Whether the day of immunisation was considered ‘‘day one” or
‘‘day zero” in the analysis;
Whether the date of onset (see footnote 3) and/or the date of
first observation (see footnote 4) and/or the date of diagnosis
(see footnote 5) was used for analysis; and
Use of this case definition for Neonatal encephalopathy, in the
abstract or methods section of a publication.14
Disclaimer
The findings, opinions and assertions contained in this consen-
sus document are those of the individual scientific professional
members of the working group. They do not necessarily represent
the official positions of each participant’s organisation (e.g., gov-
ernment, university, or corporation). Specifically, the findings and
conclusions in this paper are those of the authors and do not nec-
essarily represent the views of their respective institutions.
Acknowledgements
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. The authors are also
grateful to Jan Bonhoeffer, Jorgen Bauwens of the Brighton Collab-
oration Secretariat and Sonali Kochhar of Global Healthcare Con-
sulting for final revisions of the final document. Finally, we
would like to acknowledge the Global Alignment of Immunisation
Safety Assessment in Pregnancy (GAIA) project, funded by the Bill
and Melinda Gates Foundation.
Appendix A. Supplementary material
Supplementary data associated with this article can be found, in
the online version, at http://dx.doi.org/10.1016/j.vaccine.2017.01.
045.
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14
Use of this document should preferably be referenced by referring to the
respective link on the Brighton Collaboration website (http://www.brightoncollabo-
ration.org).
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