SINEPOST study
Research type
Research Study
Full title
SARS-CoV-2 Infection in NEonates or in Pregnancy: Outcomes at EighTeen months
IRAS ID
294183
Contact name
Ela Chakkarapani
Contact email
Sponsor organisation
Research and Enterprise, University of Bristol.
ISRCTN Number
ISRCTN99910769
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
Two large ongoing studies, the UK Obstetric Surveillance System (UKOSS) and the British Paediatric Surveillance Unit (BPSU), identified 3000 pregnant women and 100 newborn babies who were hospitalized with the Coronavirus (SARS-CoV-2 or COVID-19) infection so far. Most of these pregnant women gave birth at term (at 37 weeks of gestation or more) and most of the newborn babies who had Coronavirus infection were also born at term. Almost all of these babies were well or were only mildly affected by the virus shortly after birth. Recent research shows that Coronavirus infection in children and adults may affect the brain. Since the development of term-born babies is not routinely checked by health professionals, we will not know whether Coronavirus infection during pregnancy or shortly after birth will affect their development as they grow. From May 2021 to October 2022, SINEPOST study will check the development of babies exposed to Coronavirus infection and compare it with the development of babies who did not have Coronavirus infection to find out if there are any lasting effects.
We will ask the Clinical Research Network research nurses in the hospitals to invite 1000 women who had Coronavirus infection during pregnancy and 1000 women who did not and to invite parents of babies who had coronavirus infection shortly after birth to participate in the study. We aim to enrol 200 children who were exposed to coronavirus infection during pregnancy, 120 children who had coronavirus infection shortly after birth and 200 children without Coronavirus infection with consent from parents. Parents will complete a questionnaire when their children are 18 months old to tell us about their child’s development and we will send the results to parents. The study results will help the NHS develop guidance for pregnant women and parents of newborn babies about Coronavirus.REC name
London - Westminster Research Ethics Committee
REC reference
21/PR/0431
Date of REC Opinion
4 May 2021
REC opinion
Further Information Favourable Opinion