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House Bill 1306 Industry, Business and Labor January 19, 2021, 2:45
House Bill 1306 Industry, Business and Labor January 19, 2021, 2:45 p.m. Good Morning Chairman Weisz and members of the House Human Services Committee. My name is Molly Howell and I am the Immunization Director of for the North Dakota Department of Health. I do not have testimony for HB1306 but want to let you know I am available virtually to answer questions, if needed. Additionally, attached is a list of studies that have been previously published regarding vaccines, autism and SIDS. Thank You. 1 Vaccine-Related Science: Autism and SIDS No Causal Association Found Autism Literature Reviews: Autism and Vaccines 1. Measles, Mumps, Rubella Vaccination and Autism: A Nationwide Cohort Study PDF available here Annals of Internal Medicine March 2019 The study strongly supports that MMR vaccination does not increase the risk for autism, does not trigger autism in susceptible children, and is not associated with clustering of autism cases after vaccination. It adds to previous studies through significant additional statistical power and by addressing hypotheses of susceptible subgroups and clustering of cases. 2. Autism Occurrence by MMR Vaccine Status Among US Children With Older Siblings With and Without Autism http://jama.jamanetwork.com/article.aspx?articleid=2275444 The Journal of the American Medical Association April 2015 In this large sample of privately insured children with older siblings, receipt of the MMR vaccine was not associated with increased risk of ASD, regardless of whether older siblings had ASD. These findings indicate no harmful association between MMR vaccine receipt and ASD even among children already at higher risk for ASD. -
First Trimester Anomaly Scan Using Virtual Reality (VR FETUS Study): Study Protocol for a Randomized Clinical Trial C
Pietersma et al. BMC Pregnancy and Childbirth (2020) 20:515 https://doi.org/10.1186/s12884-020-03180-8 STUDY PROTOCOL Open Access First trimester anomaly scan using virtual reality (VR FETUS study): study protocol for a randomized clinical trial C. S. Pietersma1, A. G. M. G. J. Mulders1, L. M. Moolenaar1, M. G. M. Hunink2,3,4, A. H. J. Koning5, S. P. Willemsen6, A. T. J. I. Go1, E. A. P. Steegers1 and M. Rousian1* Abstract Background: In recent years it has become clear that fetal anomalies can already be detected at the end of the first trimester of pregnancy by two-dimensional (2D) ultrasound. This is why increasingly in developed countries the first trimester anomaly scan is being offered as part of standard care. We have developed a Virtual Reality (VR) approach to improve the diagnostic abilities of 2D ultrasound. Three-dimensional (3D) ultrasound datasets are used in VR assessment, enabling real depth perception and unique interaction. The aim of this study is to investigate whether first trimester 3D VR ultrasound is of additional value in terms of diagnostic accuracy for the detection of fetal anomalies. Health-related quality of life, cost-effectiveness and also the perspective of both patient and ultrasonographer on the 3D VR modality will be studied. Methods: Women in the first trimester of a high risk pregnancy for a fetus with a congenital anomaly are eligible for inclusion. This is a randomized controlled trial with two intervention arms. The control group receives ‘care as usual’: a second trimester 2D advanced ultrasound examination. The intervention group will undergo an additional first trimester 2D and 3D VR ultrasound examination. -
GMEC) Strategic Clinical Networks Reduced Fetal Movement (RFM
Greater Manchester & Eastern Cheshire (GMEC) Strategic Clinical Networks Reduced Fetal Movement (RFM) in Pregnancy Guidelines March 2019 Version 1.3a GMEC RFM Guideline FINAL V1.3a 130619 Issue Date 15/02/2019 Version V1.3a Status Final Review Date Page 1 of 19 Document Control Ownership Role Department Contact Project Clinical Lead Manchester Academic Health [email protected] Science Centre, Division of Developmental Biology and Medicine Faculty of Biology, Medicine and Health, The University of Manchester. Project Manager GMEC SCN [email protected] Project Officer GMEC SCN [email protected] Endorsement Process Date of Presented for ratification at GMEC SCN Maternity Steering Group on:15th February ratification 2019 Application All Staff Circulation Issue Date: March 2019 Circulated by [email protected] Review Review Date: March 2021 Responsibility of: GMEC Maternity SCN Date placed on March 2019 the Intranet: Acknowledgements On behalf of the Greater Manchester and Eastern Cheshire and Strategic Clinical Networks, I would like to take this opportunity to thank the contributors for their enthusiasm, motivation and dedication in the development of these guidelines. Miss Karen Bancroft Maternity Clinical Lead for the Greater Manchester & Eastern Cheshire SCN GMEC RFM Guideline FINAL V1.3a 130619 Issue Date 15/02/2019 Version V1.3a Status Final Review Date Page 2 of 19 Contents 1 What is this Guideline for and Who should use it? ......................................................................... 4 2 What -
Rotateq Safety and Utilization Review
Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research MEMORANDUM To: Craig Zinderman, MD, MPH Associate Director for Medical Policy Office of Biostatistics and Epidemiology (OBE) Center for Biologics Evaluation and Research (CBER) Through: Meghna Alimchandani, MD Deputy Director, Division of Epidemiology (DE), OBE, CBER From: Phillip Blanc, MD Medical Officer, Analytic Epidemiology Branch, DE, OBE, CBER Subject: Safety and Utilization Review for the Pediatric Advisory Committee Applicant: Merck Product: RotaTeq® (rotavirus vaccine, live, oral, pentavalent) STN: 125122/1589 Indication: RotaTeq® is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by types G1, G2, G3, G4, and G9 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq® should be administered between 6 and 12 weeks of age. Meeting Date: Pediatric Advisory Committee Meeting, September 2021 Page 1 of 30 Contents 1 INTRODUCTION ................................................................................................................................ 3 1.1 Objective ...................................................................................................................................... 3 1.2 Product Description .................................................................................................................... 3 1.3 Regulatory History ..................................................................................................................... -
ANC Level 1 2Nd Edition.Pdf
Pregnancy & Childbirth Management Guidelines Level- 1 A Guide for Nurses, Midwives and Doctors Second Edition DEPARTMENT OF WOMAN &CHILD HEALTH DIRECTORATE GENERAL OF PRIMARY HEALTH CARE MINISTRY OF HEALTH SULTANATE OF OMAN 2016 ML- 60 Pregnancy & Childbirth Management Guidelines Level- 1 A Guide for Nurses, Midwives and Doctors Second Edition 2016 I II ACKNOWLEDGEMENT Acknowledgement with gratitude to all contributors & Reviewers for their effort in updating this guideline manual: Contributors from Woman & Child Health Department: • Dr. Jamila Al-Abri, Senior Specialist, Dept. of Woman & Child Health • Dr. Fatima Al Hinai, Senior Specialist, Director of Woman & Child Health Dept. • Dr. Nawal Al Rashdi, Senior Specialist, Dept. of Woman & Child Health • Dr. Salwa Jabbar Alshahabi, Specialist, Dept. of Woman & Child Health • Dr. Omaima Abdel Wahab, Senior Medical Officer, Dept. of Woman & Child Health. Contributors from Primary Health Care Institutions: • Dr. Nabila Al Wahaibi, Senior Consultant (FAMCO), Wadi Kabeer Health Centre. • Dr. Ahdab Abdul Hafeez, Specialist, Muscat Health Centre. • Dr. Imrana Masoud, Senior Medical Officer, Al Seeb Health Centre. Contributors from National Diabetic & Endocrine Centre & NCD department • Dr. Noor Al Busaidi, Senior Consultant, Director of National Diabetic & Endocrine Centre (NDEC) • Dr. Hilal Al Musailhi, Senior Consultant Adult Endocrinology, (NDEC). • Dr. Deepa Manoharan , Medical Officer, (NDEC). • Dr. Nada Hareb Al Sumri, Senior Specialist, Non Communicable Disease Dept • Dr. Suleiman Al Shereigi, Senior Specialist in Public Health Administration,(NDEC) Reviewers from Secondary & Tertiary Heath Care : • Dr. Tamima Al Dughaishi, Senior Consultant Obstetrics & Gynecology, SQUH • Dr. Bernadette Punnoose, Senior Consultant Obstetrics & Gynecology, Royal Hospital • Dr. Badrya Al Fahdi, Senior Consultant Obstetrics & Gynecology, Royal Hospital • Dr. Sumaya Al Amri, Senior Specialist Obstetrics & Gynecology, Royal Hospital • Dr. -
Prenatal Ultrasonography of Craniofacial Abnormalities
Prenatal ultrasonography of craniofacial abnormalities Annisa Shui Lam Mak, Kwok Yin Leung Department of Obstetrics and Gynaecology, Queen Elizabeth Hospital, Hong Kong SAR, China REVIEW ARTICLE https://doi.org/10.14366/usg.18031 pISSN: 2288-5919 • eISSN: 2288-5943 Ultrasonography 2019;38:13-24 Craniofacial abnormalities are common. It is important to examine the fetal face and skull during prenatal ultrasound examinations because abnormalities of these structures may indicate the presence of other, more subtle anomalies, syndromes, chromosomal abnormalities, or even rarer conditions, such as infections or metabolic disorders. The prenatal diagnosis of craniofacial abnormalities remains difficult, especially in the first trimester. A systematic approach to the fetal Received: May 29, 2018 skull and face can increase the detection rate. When an abnormality is found, it is important Revised: June 30, 2018 to perform a detailed scan to determine its severity and search for additional abnormalities. Accepted: July 3, 2018 Correspondence to: The use of 3-/4-dimensional ultrasound may be useful in the assessment of cleft palate and Kwok Yin Leung, MBBS, MD, FRCOG, craniosynostosis. Fetal magnetic resonance imaging can facilitate the evaluation of the palate, Cert HKCOG (MFM), Department of micrognathia, cranial sutures, brain, and other fetal structures. Invasive prenatal diagnostic Obstetrics and Gynaecology, Queen Elizabeth Hospital, Gascoigne Road, techniques are indicated to exclude chromosomal abnormalities. Molecular analysis for some Kowloon, Hong Kong SAR, China syndromes is feasible if the family history is suggestive. Tel. +852-3506 6398 Fax. +852-2384 5834 E-mail: [email protected] Keywords: Craniofacial; Prenatal; Ultrasound; Three-dimensional ultrasonography; Fetal structural abnormalities This is an Open Access article distributed under the Introduction terms of the Creative Commons Attribution Non- Commercial License (http://creativecommons.org/ licenses/by-nc/3.0/) which permits unrestricted non- Craniofacial abnormalities are common. -
Fetal Medicine August 2010
Advanced Training Skills Module – Fetal Medicine August 2010 Fetal Medicine This module is designed to prepare the future consultant for dealing with congenital abnormalities detected during pregnancy. This includes the organisation and supervision of screening programmes for structural and chromosomal anomalies. Many of these cases need to be managed within a multidisciplinary team which includes clinical geneticists and fetal medicine subspecialists. Apart from a sound knowledge of embryology and fetal physiology, clinicians working in this field must be competent in the prenatal diagnosis of common abnormalities. They also require a sound working knowledge of clinical and laboratory genetics in order that they can investigate and, where appropriate, refer suitable families. Competence in obstetric ultrasound is a prerequisite for advanced skills in prenatal diagnosis and fetal medicine. Trainees must complete the new Intermediate Ultrasound of Fetal Anatomy module prior to entry into the ATSM in Fetal Medicine. Attendance at a suitable Fetal Medicine theoretical course is a compulsory requirement of the module. This must be attended before completion of the ATSM and can have been done not more than three years previously. Specifically, once trained, individuals should: Work well as part of a multidisciplinary team Understand the organization of prenatal screening and diagnostic services at a local and regional level Be clinically competent in the prenatal diagnosis, counselling and management of common fetal abnormalities and markers of chromosomal abnormality. Be clinically competent and certified in first trimester screening for chromosomal abnormality by a combination of nuchal translucency assessment and biochemical marker assays. Be clinically competent at amniocentesis and have a sound knowledge of the principles and techniques of first trimester chorion villus biopsy. -
Chapter III: Case Definition
NBDPN Guidelines for Conducting Birth Defects Surveillance rev. 06/04 Appendix 3.5 Case Inclusion Guidance for Potentially Zika-related Birth Defects Appendix 3.5 A3.5-1 Case Definition NBDPN Guidelines for Conducting Birth Defects Surveillance rev. 06/04 Appendix 3.5 Case Inclusion Guidance for Potentially Zika-related Birth Defects Contents Background ................................................................................................................................................. 1 Brain Abnormalities with and without Microcephaly ............................................................................. 2 Microcephaly ............................................................................................................................................................ 2 Intracranial Calcifications ......................................................................................................................................... 5 Cerebral / Cortical Atrophy ....................................................................................................................................... 7 Abnormal Cortical Gyral Patterns ............................................................................................................................. 9 Corpus Callosum Abnormalities ............................................................................................................................. 11 Cerebellar abnormalities ........................................................................................................................................ -
Prenatal Prediction of Outcome by Fetal Gastroschisis in a Tertiary Referral Center
diagnostics Article Prenatal Prediction of Outcome by Fetal Gastroschisis in a Tertiary Referral Center Katharina Nitzsche 1, Guido Fitze 2, Mario Rüdiger 3 and Cahit Birdir 1,* 1 Department of Obstetrics and Gynecology, University Clinic of Carl Gustav Carus Dresden, Technische Universität Dresden, 01307 Dresden, Germany; [email protected] 2 Department of Pediatric Surgery, University Clinic of Carl Gustav Carus Dresden, Technische Universität Dresden, 01307 Dresden, Germany; guido.fi[email protected] 3 Department of Pediatrics, University Clinic of Carl Gustav Carus Dresden, Technische Universität Dresden, 01307 Dresden, Germany; [email protected] * Correspondence: [email protected] Received: 4 June 2020; Accepted: 30 July 2020; Published: 30 July 2020 Abstract: The aim of this study was to find a prenatal parameter to be able to predict possible prenatal complications or postnatal surgical options, thus allowing the fetal medicine specialist, together with pediatric surgeons and neonatologists, to improve the counseling of the parents and to determine the timing of delivery and therapy. This was a retrospective analysis of prenatal diagnosis and outcome of fetuses with 34 cases of gastroschisis between the years 2007 and 2017. A total of 34 fetuses with gastroschisis were examined and 33 outcomes registered: 22 cases of simple gastroschisis (66.7%) and 11 cases of complex gastroschisis (33.3%). A cut-off value of 18 mm for intraabdominal bowel dilatation (IABD) showed a positive predictive value (PPV) of 100% for predicting simple gastroschisis. IABD gives the best prediction for simple versus complex gastroschisis (cut-off of 18 mm). Extra-abdominal bowel dilatation (EABD) cut-off values of 10 mm and 18 mm showed low sensitivity and specificity to predict complex gastroschisis. -
MATERNAL SCREENING for FOETAL ABNORMALITY Assessment Assessment
REP ORT MATERNAL SCREENING FOR FOETAL ABNORMALITY assessment assessment HEALTH TECHNOLOGY ASSESSMENT UNIT MEDICAL DEVELOPMENT DIVISION health MINISTRY OF HEALTH MALAYSIA MOH/PAK/59.03(TR) 1 MEMBERS OF EXPERT COMMITTEE Dr Zaridah Shafie Obstetric & Gynecology Consultant Kangar Hospital Dr Zulkfili Mohd Kassim Pakar Perunding O & G Hospital Kuala Terengganu Dr Mohd Rouse Abd Majid Obstetric & Gynecology Consultant Sg Petani Hospital Dr Neoh Siew Hong Pediatric Consultant Taiping Hospital Dr Rosnah Sutan Jabatan Kesihatan Bersekutu National University of Malaysia Prof Jamiyah Hassan Faculty of Medicine University Malaya Project Coordinators Dr S Sivalal Deputy Director Health Technology Assessment Unit Ministry of Health Malaysia Dr Rusilawati Jaudin Principal Assistant Director Health Technology Assessment Unit Ministry of Health Malaysia Ms Sin Lian Thye Nursing Sister Health Technology Assessment Unit Ministry of Health Malaysia 2 EXECUTIVE SUMMARY INTRODUCTION Congenital malformations are structural or anatomical defects that are present at birth, resulting from influences acting on the developing embryo in early pregnancy. Some congenital malformations are potentially preventable; however, they remain major causes of early death, hospitalization of infants and young children and significant long-term physical and developmental disabilities. Screening and early detection of Downs Syndrome and other chromosomal anomalies in-utero provides several benefits like the opportunity to inform parents and counseling on the likelihood of delivery -
Battling the Myths and Fears Regarding Pediatric Vaccines
10/5/18 BATTLING THE MYTHS AND FEARS REGARDING PEDIATRIC VACCINES RC Hellinga, Pharm.D., BCPPS UNMH Pediatric ICU Pharmacist 10/8/2018 Disclosures • Nothing to disclose 1 10/5/18 Pharmacist Objectives • Describe 5 of the most common myths/fears surrounding pediatric vaccines • Review the pediatric vaccine schedule and frequency • Explain the mechanism of action for pediatric vaccines • Evaluate the data surrounding the most common myths/fears of pediatric vaccines • Construct a plan for families with concerns regarding pediatric vaccines Technician Objectives • List 5 of the common myths/fears surrounding pediatric vaccines • Describe the pediatric vaccine schedule and frequency • Describe the mechanism of action for pediatric vaccines • Explain the potential side effects regarding pediatric vaccines 2 10/5/18 Background • Misconceptions about vaccinations are common • Patients and/or parents question the safety and utility of vaccines • Healthcare workers need to be: • Mindful • Knowledgeable • Timely • Healthcare workers miss opportunities to vaccinate based on their own false contraindications and unnecessary rules • This presentation will help you as a provider address the patient’s and/or parent’s concern regarding the safety and efficacy surrounding pediatric vaccines Vaccine Preventable Diseases – General Pediatric Population in the USA • Hepatitis • Poliovirus • Hepatitis A • Hepatitis B • Influenza • Inactivated influenza vaccine • Rotavirus • Live attenuated influenza vaccine • Diphtheria, Tetanus, Pertussis • Measles, Mumps, Rubella • DTaP • Tdap • Varicella • Haemophilus influenzae type b • Meningococcal • MenACWY-D/MenACWY-CRM • Pneumococcal • Meningococcal B • Pneumococcal conjugate (PCV 13) • Pneumococcal polysaccharide (PPSV 23) • Human papillomavirus 3 10/5/18 Andrew Wakefield Jenny McCarthy and Vaccines 4 10/5/18 Comparison of Vaccine Schedules • Total number of vaccines in the USA – 35+ vaccines • Schedule breaks it into individual products • Combination products: Pentacel, Pediarix, etc. -
One Stop Documentation and CTG Monitoring
From the first day of pregnancy to delivery: One Stop Documentation and CTG Monitoring WEEK 8 WEEK 11 Beginning of Early Pregnancy First Trimester Pregnancy Ultrasound Scan WEEK 36 WEEK 30 WEEK 18 CTG Monitoring Growth Scan Anomaly Scan WEEK 40 CTG Monitoring, Pregnancy Outcomes Delivery Documentation of Room Labour Progress (Partogram) gehealthcare.com/viewpoint From the first ultrasound examination to delivery, ViewPoint™ 6 in combination with Trium CTG Online1 can help you focus on the patient and her baby. Your clinical workflows in the OB/GYN department can now be covered by a single solution. GE offers you a comprehensive solution for digital, paperless documentation throughout pregnancy and birth. ViewPoint 6 was developed to significantly simplify image management, reporting and workflows in hospitals and private practices. Patient data, detailed and structured findings, and images are clearly available in one view. ViewPoint 6 offers examination types for: • Pelvic Ultrasound (including IOTA2) • Growth Scan • Early Pregnancy • Fetal Wellbeing including Biophysical Profile • 1st Trimester Ultrasound including FMF risk assessment2 • Pregnancy Outcome • 2nd/3rd Trimester Ultrasound ViewPoint 6 can be linked to Trium CTG Online1. Trium CTG Online allows you to keep track of all CTG traces, provides decision support and digital archiving and exchange of delivery data for documentation purposes. Trium CTG Online allows to keep your focus on the patient Centralized and Decentralized CTG Monitoring Comprehensive Documentation • Survey