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Clinical profile of neonates with suspected or proven SARS-CoV-2 infectio

Not Applicable
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
Inclusion Criteria

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

Exclusion Criteria

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
NameTimeMethod
Incidence of vertical transmission (positive RT-PCR in first sample)Timepoint: At birth and at 5-14 days of life
Secondary Outcome Measures
NameTimeMethod
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
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