Cargando…

Effect of SARS-CoV-2 infection in neonates or in pregnancy on developmental outcomes at 21–24 months (SINEPOST): study protocol for a prospective cohort study

INTRODUCTION: Exposure to SARS-CoV-2 during pregnancy or in the neonatal period may impact fetal or neonatal brain development either through direct central nervous system infection or indirectly through the adverse effects of viral infection-related inflammation in the mother or newborn infant. Thi...

Descripción completa

Detalles Bibliográficos
Autores principales: Woodward, Kathryn, Cornish, Rosie P, Gale, Chris, Johnson, Samantha, Knight, Marian, Kurinczuk, Jenny, Chakkarapani, Ela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9485650/
https://www.ncbi.nlm.nih.gov/pubmed/36645759
http://dx.doi.org/10.1136/bmjpo-2022-001571
_version_ 1784792119766941696
author Woodward, Kathryn
Cornish, Rosie P
Gale, Chris
Johnson, Samantha
Knight, Marian
Kurinczuk, Jenny
Chakkarapani, Ela
author_facet Woodward, Kathryn
Cornish, Rosie P
Gale, Chris
Johnson, Samantha
Knight, Marian
Kurinczuk, Jenny
Chakkarapani, Ela
author_sort Woodward, Kathryn
collection PubMed
description INTRODUCTION: Exposure to SARS-CoV-2 during pregnancy or in the neonatal period may impact fetal or neonatal brain development either through direct central nervous system infection or indirectly through the adverse effects of viral infection-related inflammation in the mother or newborn infant. This study aims to determine whether there are early neurodevelopmental effects of SARS-CoV-2 infection. METHODS AND ANALYSIS: We will conduct a prospective national population-based cohort study of children aged 21–24 months who were born at term (≥37 weeks’ gestation) between 1 March 2020 and 28 February 2021 and were either antenatally exposed, neonatally exposed or unexposed (comparison cohort) to SARS-CoV-2. Nationally, hospitals will identify and approach parents of children eligible for inclusion in the antenatally and neonatally exposed cohorts using information from the UK Obstetric Surveillance System (UKOSS) and British Paediatric Surveillance Unit (BPSU) national surveillance studies and will identify and approach eligible children for the comparison cohort through routine birth records. Parents will be asked to complete questionnaires to assess their child’s development at 21–24 months of age. Outcome measures comprise the Ages and Stages Questionnaire, Third Edition (ASQ-3), Ages and Stages Questionnaire Social-Emotional, Second Edition (ASQ-SE-2), Liverpool respiratory symptoms questionnaire and questionnaire items to elicit information about healthcare usage. With parental consent, study data will be linked to routine health and education records for future follow-up. Regression models will compare ASQ-3 and ASQ-SE-2 scores and proportions, frequency of respiratory symptoms and healthcare usage between the exposed and comparison cohorts, adjusting for potential confounders. ETHICS AND DISSEMINATION: Ethics approval was obtained from the London-Westminster Research Ethics Committee. Findings will be disseminated in scientific conference presentations and peer-reviewed publications. ISRCTN REGISTRATION NUMBER: ISRCTN99910769.
format Online
Article
Text
id pubmed-9485650
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher BMJ Publishing Group
record_format MEDLINE/PubMed
spelling pubmed-94856502022-09-20 Effect of SARS-CoV-2 infection in neonates or in pregnancy on developmental outcomes at 21–24 months (SINEPOST): study protocol for a prospective cohort study Woodward, Kathryn Cornish, Rosie P Gale, Chris Johnson, Samantha Knight, Marian Kurinczuk, Jenny Chakkarapani, Ela BMJ Paediatr Open Protocol INTRODUCTION: Exposure to SARS-CoV-2 during pregnancy or in the neonatal period may impact fetal or neonatal brain development either through direct central nervous system infection or indirectly through the adverse effects of viral infection-related inflammation in the mother or newborn infant. This study aims to determine whether there are early neurodevelopmental effects of SARS-CoV-2 infection. METHODS AND ANALYSIS: We will conduct a prospective national population-based cohort study of children aged 21–24 months who were born at term (≥37 weeks’ gestation) between 1 March 2020 and 28 February 2021 and were either antenatally exposed, neonatally exposed or unexposed (comparison cohort) to SARS-CoV-2. Nationally, hospitals will identify and approach parents of children eligible for inclusion in the antenatally and neonatally exposed cohorts using information from the UK Obstetric Surveillance System (UKOSS) and British Paediatric Surveillance Unit (BPSU) national surveillance studies and will identify and approach eligible children for the comparison cohort through routine birth records. Parents will be asked to complete questionnaires to assess their child’s development at 21–24 months of age. Outcome measures comprise the Ages and Stages Questionnaire, Third Edition (ASQ-3), Ages and Stages Questionnaire Social-Emotional, Second Edition (ASQ-SE-2), Liverpool respiratory symptoms questionnaire and questionnaire items to elicit information about healthcare usage. With parental consent, study data will be linked to routine health and education records for future follow-up. Regression models will compare ASQ-3 and ASQ-SE-2 scores and proportions, frequency of respiratory symptoms and healthcare usage between the exposed and comparison cohorts, adjusting for potential confounders. ETHICS AND DISSEMINATION: Ethics approval was obtained from the London-Westminster Research Ethics Committee. Findings will be disseminated in scientific conference presentations and peer-reviewed publications. ISRCTN REGISTRATION NUMBER: ISRCTN99910769. BMJ Publishing Group 2022-09-19 /pmc/articles/PMC9485650/ /pubmed/36645759 http://dx.doi.org/10.1136/bmjpo-2022-001571 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
spellingShingle Protocol
Woodward, Kathryn
Cornish, Rosie P
Gale, Chris
Johnson, Samantha
Knight, Marian
Kurinczuk, Jenny
Chakkarapani, Ela
Effect of SARS-CoV-2 infection in neonates or in pregnancy on developmental outcomes at 21–24 months (SINEPOST): study protocol for a prospective cohort study
title Effect of SARS-CoV-2 infection in neonates or in pregnancy on developmental outcomes at 21–24 months (SINEPOST): study protocol for a prospective cohort study
title_full Effect of SARS-CoV-2 infection in neonates or in pregnancy on developmental outcomes at 21–24 months (SINEPOST): study protocol for a prospective cohort study
title_fullStr Effect of SARS-CoV-2 infection in neonates or in pregnancy on developmental outcomes at 21–24 months (SINEPOST): study protocol for a prospective cohort study
title_full_unstemmed Effect of SARS-CoV-2 infection in neonates or in pregnancy on developmental outcomes at 21–24 months (SINEPOST): study protocol for a prospective cohort study
title_short Effect of SARS-CoV-2 infection in neonates or in pregnancy on developmental outcomes at 21–24 months (SINEPOST): study protocol for a prospective cohort study
title_sort effect of sars-cov-2 infection in neonates or in pregnancy on developmental outcomes at 21–24 months (sinepost): study protocol for a prospective cohort study
topic Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9485650/
https://www.ncbi.nlm.nih.gov/pubmed/36645759
http://dx.doi.org/10.1136/bmjpo-2022-001571
work_keys_str_mv AT woodwardkathryn effectofsarscov2infectioninneonatesorinpregnancyondevelopmentaloutcomesat2124monthssinepoststudyprotocolforaprospectivecohortstudy
AT cornishrosiep effectofsarscov2infectioninneonatesorinpregnancyondevelopmentaloutcomesat2124monthssinepoststudyprotocolforaprospectivecohortstudy
AT galechris effectofsarscov2infectioninneonatesorinpregnancyondevelopmentaloutcomesat2124monthssinepoststudyprotocolforaprospectivecohortstudy
AT johnsonsamantha effectofsarscov2infectioninneonatesorinpregnancyondevelopmentaloutcomesat2124monthssinepoststudyprotocolforaprospectivecohortstudy
AT knightmarian effectofsarscov2infectioninneonatesorinpregnancyondevelopmentaloutcomesat2124monthssinepoststudyprotocolforaprospectivecohortstudy
AT kurinczukjenny effectofsarscov2infectioninneonatesorinpregnancyondevelopmentaloutcomesat2124monthssinepoststudyprotocolforaprospectivecohortstudy
AT chakkarapaniela effectofsarscov2infectioninneonatesorinpregnancyondevelopmentaloutcomesat2124monthssinepoststudyprotocolforaprospectivecohortstudy