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

Clinical profile of neonates born to mothers with SARS-CoV-2 infection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/10/028202
Enrollment
30
Registered
2020-10-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

Interventions

None listed

Sponsors

Dr Deepak Chawla
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: There are no exclusion criteria apart from refusal of parents to participate in the study (prospective arm).

Design outcomes

Primary

MeasureTime frame
Incidence of vertical transmission (positive RT-PCR in first sample)Timepoint: At birth and at 5-14 days of life

Secondary

MeasureTime frame
Incidence of pneumonia (clinical or radiographic) 2. Need of NICU admission 3. Incidence of vertical transmission (positive RT-PCR in first sample) 4. Incidence of neonatal infection (vertical or horizontal) 5. Need of respiratory support 6. Duration of respiratory support 7. Incidence of major neonatal morbidities 8. Neonatal mortality rateTimepoint: 28 days

Countries

India

Contacts

Public ContactDeepak Chawla

Government Medical College Hospital

drdeepak@gmch.gov.in9646121559

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026