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

Not Applicable

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN99910769
• Lead Sponsor: niversity of Bristol

Brief Summary

2022 Protocol article in https://doi.org/10.1136/bmjpo-2022-001571 (added 17/01/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-06
• Last Update Posted: 30 January 2023
• Study Completion: 2023-12-17

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 520

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 2. Proportion of ASQ-3 domain scores below the established cut-offs which identify possible developmental delay, measured at 21-24 months old<br> 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<br> 4. Respiratory symptoms measured using the mean Liverpool Respiratory Symptoms Questionnaire (LRSQ) total score at 21-24 months old<br> 5. Frequency of health care usage measured using a non-validated questionnaire at 21-24 months old<br>