Neonatal CoVID-19 Study to evaluate the population health impacts of COVID-19 in mothers and their newborn infants cared for in tertiary and non-tertiary hospitals in Australia.

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12620000527965

Acronym

NCoS

Enrollment

1000

Registered

2020-04-29

Start date

2020-05-01

Completion date

2020-11-30

Last updated

2021-09-07

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

Conditions

None listed

Brief summary

In the midst of an unfolding global pandemic, there is a dearth of information about how COVID 19 infection affects neonates born to women with suspected or proven COVID 19. This study will contribute to an emerging and global body of information about COVID 19 in the perinatal period, enabling timely reporting and appropriate health service planning to ensure optimal outcomes for neonates, mothers and families. The aim of this project is to investigate the population health impacts of COVID -19 in mothers and their newborn infants cared for in tertiary and non-tertiary neonatal facilities. The research questions/hypothesis this study seeks to address include: 1. Incidence of COVID-19 in pregnant women and their newborn infants 2. Describe the outcomes for mothers and their newborn infants with COVID-19 3. Identify incidence of SARS-CoV-2 infection in the neonatal period and describe clinical course and outcomes for newborn infants with COVID-19 4. Collaborate with international COVID-19 registries to inform global variations and outcomes in care of newborn infants

Interventions

This project uses a quantitative research methodology that will collect data using a prospective population based registry via a RedCap™ online database. Data collected on the study database is already routinely collected clinical data such as resuscitation details at birth, APGAR scores, need for ICU or HDU admission, feeding details and follow-up at 2 years of age. All data collection will occur from relevant hospital records and no specific input from patients is required. This methodology is appropriate to answer the research question because it allows for de-identified input from multiple study sites, and ongoing quantitative analysis and reporting including longer term outcomes for neonates at 2 years of age.

Eligibility

Sex/Gender

All

Age

0 to 45 Years

Healthy volunteers

Inclusion criteria

COVID-19 confirmed infants or infants born to COVID-19 confirmed mothers

Exclusion criteria

Pregnant and/or post-partum women and neonates who do not meet suspect or confirmed case definition of COVID-19.

Outcome results