Clinical profile of neonates with suspected or proven SARS-CoV-2 infectio
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2020/10/028202
- Lead Sponsor
- Dr Deepak Chawla
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Following neonates will be enrolled in the study
1. Neonates born in the hospital with COVID-19 infection in pregnant mother within 2 weeks before birth
2. Neonates presenting to the hospital with history of postnatal exposure to infected mother, other family member or healthcare
provider.
3. Neonates presenting with severe acute respiratory illness after 48-72 h of birth with illness which cannot be explained by other
causes or perinatal events (irrespective of history of exposure) and test positive for COVID-19 infection
There are no exclusion criteria apart from refusal of parents to participate in the study (prospective arm).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of vertical transmission (positive RT-PCR in first sample)Timepoint: At birth and at 5-14 days of life
- Secondary Outcome Measures
Name Time Method Incidence of pneumonia (clinical or radiographic) <br/ ><br>2. Need of NICU admission <br/ ><br>3. Incidence of vertical transmission (positive RT-PCR in first <br/ ><br>sample) <br/ ><br>4. Incidence of neonatal infection (vertical or horizontal) <br/ ><br>5. Need of respiratory support <br/ ><br>6. Duration of respiratory support <br/ ><br>7. Incidence of major neonatal morbidities <br/ ><br>8. Neonatal mortality rateTimepoint: 28 days