The impact of COVID-19 infection in newborns or in pregnancy on children’s development at 18-24 months

SARS-CoV-2 Infection in NEonates or in Pregnancy: Outcomes at EighTeen months (SINEPOST)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN99910769

Enrollment

520

Registered

2022-06-06

Start date

2021-11-16

Completion date

Unknown

Last updated

2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

SINEPOST is a population-based cohort study that is linked to the national surveillance studies of pregnant women (UK Obstetric Surveillance System) and newborn babies (British Paediatric Surveillance

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For the coronavirus-exposed cohort, any term (=37 weeks gestation) baby: 1. Born to women who had confirmed coronavirus infection between 14 and 36 weeks of pregnancy will form the antenatal exposure cohort OR 2. Who had confirmed coronavirus infection within 28 days of birth will form the neonatal exposure cohort The comparator cohort will include any term baby: 1. Who did not have coronavirus infection within 28 days of birth AND 2. Born to women who did not have coronavirus infection during pregnancy in the same period as the antenatal exposure cohort

Exclusion criteria

Exclusion criteria: 1. Children born prematurely at less than 37 weeks gestation 2. Children with a major congenital anomaly 3. Children born following multiple pregnancies

Design outcomes

Primary

Measure	Time frame
Child development measured using the mean Ages and Stages Questionnaire (ASQ-3) total score at 21-24 months old	—

Secondary

Measure	Time frame
1. Proportion with one or more ASQ-3 domain scores below the established cut-offs which identify possible developmental delay, measured at 21-24 months old 2. Proportion of ASQ-3 domain scores below the established cut-offs which identify possible developmental delay, measured at 21-24 months old 3. Child development measured using the Mean Ages and Stages Questionnaire: Social-Emotional (ASQ-SE-2) total score and the proportion of ASQ-SE-2 total scores above the established cut-offs which identify possible developmental delay, measured at 21-24 months old 4. Respiratory symptoms measured using the mean Liverpool Respiratory Symptoms Questionnaire (LRSQ) total score at 21-24 months old 5. Frequency of health care usage measured using a non-validated questionnaire at 21-24 months old	—

Measure

Time frame

1. Proportion with one or more ASQ-3 domain scores below the established cut-offs which identify possible developmental delay, measured at 21-24 months old 2. Proportion of ASQ-3 domain scores below the established cut-offs which identify possible developmental delay, measured at 21-24 months old 3. Child development measured using the Mean Ages and Stages Questionnaire: Social-Emotional (ASQ-SE-2) total score and the proportion of ASQ-SE-2 total scores above the established cut-offs which identify possible developmental delay, measured at 21-24 months old 4. Respiratory symptoms measured using the mean Liverpool Respiratory Symptoms Questionnaire (LRSQ) total score at 21-24 months old 5. Frequency of health care usage measured using a non-validated questionnaire at 21-24 months old

—

Countries

England, Guernsey, United Kingdom, Wales

Contacts

Public ContactSINEPOST Study

sinepost-study@bristol.ac.uk+44 (0)7862 320528

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026