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. 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.

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. 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.

Neonatal complications of SARS-CoV-2 infection in the UK: a prospective national cohort study using active surveillance

1206 Figure 1Weekly number of neonates admitted who have confirmed SARS-CoV-2 by date of diagnosis, UK, 1st March 2020 to 7th November 2021[Figure omitted. See PDF] 1206 Table 1Maternal and neonatal mortality in association with SARS-CoV-2 infection, UK 01/03/2020-31/10/2021ConclusionUsing population level surveillance data we describe neonatal complications directly and indirectly attributable to SARS-CoV-2 infection during the first three pandemic waves. This study demonstrates the low risk to neonates despite the emergence of new variants. Continued surveillance will allow the impacts of new variants on the neonatal population to be characterised.ReferencesGale C, Quigley MA, Placzek A, et al. Characteristics and outcomes of neonatal SARS-CoV-2 infection in the UK: a prospective national cohort study using active surveillance. Lancet Child Adolesc Heal 2021;5:113–21.Vousden N, Ramakrishnan R, Bunch K, et al. Impact of SARS-CoV-2 variant on the severity of maternal infection and perinatal outcomes: Data from the UK Obstetric Surveillance System national cohort. Medrvix 2021. doi:10.1101/2021.07.22.21261000.Knight M, Kurinczuk JJ, Tuffnell D, Brocklehurst P. The UK Obstetric Surveillance System for raredisorders of pregnancy. BJOG An Int J Obstet Gynaecol 2005;112:263–5.