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Trial registered on ANZCTR


Registration number
ACTRN12620000527965
Ethics application status
Approved
Date submitted
27/04/2020
Date registered
29/04/2020
Date last updated
29/04/2020
Date data sharing statement initially provided
29/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 301130 0
None
Universal Trial Number (UTN)
U1111-1250-9525
Trial acronym
NCoS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 317239 0
Condition category
Condition code
Infection 315374 315374 0 0
Other infectious diseases
Respiratory 315379 315379 0 0
Other respiratory disorders / diseases
Public Health 315380 315380 0 0
Epidemiology
Reproductive Health and Childbirth 315394 315394 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
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.
Intervention code [1] 317438 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323625 0
Need for resuscitation - collected from hospital records
Timepoint [1] 323625 0
At birth
Primary outcome [2] 323629 0
Type of respiratory support required after birth - collected from hospital records
Timepoint [2] 323629 0
First week of life
Primary outcome [3] 323630 0
Mortality - collected from hospital records
Timepoint [3] 323630 0
Discharge
Secondary outcome [1] 382410 0
Neurodevelopmental outcome for newborn infants affected by COVID-19 or born to COVID-19 affected mothers - assessed by Bayley-IV neurological examination for infants born <29 weeks gestation and by ASQ assessment for infants born >29 weeks gestation
Timepoint [1] 382410 0
24 months
Secondary outcome [2] 382457 0
Location of hospital admission for newborn infant - data collected from hospital records
Timepoint [2] 382457 0
At time of admission
Secondary outcome [3] 382471 0
Feeding type - breast feeding/expressed breast milk via bottle or tube/formula feeding/Donor breast milk - data collected from clinical notes.
Timepoint [3] 382471 0
Data collected at time of admission

Eligibility
Key inclusion criteria
COVID-19 confirmed infants or infants born to COVID-19 confirmed mothers
Minimum age
0 Days
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant and/or post-partum women and neonates who do not meet suspect or confirmed case definition of COVID-19.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Descriptive analysis and reporting of outcomes of neonates in COVID-19 confirmed infants or infants born to COVID-19 confirmed mothers.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305570 0
Other Collaborative groups
Name [1] 305570 0
NSW Perinatal Services Network (SCHN)
Address [1] 305570 0
NSW PSN
Sydney Children's Hospital
C1 East, Level 1
High Street
RANDWICK NSW 2031
Country [1] 305570 0
Australia
Primary sponsor type
Government body
Name
Hunter New England LHD
Address
Lookout Road
New Lambton
NSW 2305
Country
Australia
Secondary sponsor category [1] 305989 0
None
Name [1] 305989 0
Address [1] 305989 0
Country [1] 305989 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305874 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 305874 0
Lookout Road
New Lambton
NSW 2305
Ethics committee country [1] 305874 0
Australia
Date submitted for ethics approval [1] 305874 0
01/04/2020
Approval date [1] 305874 0
03/04/2020
Ethics approval number [1] 305874 0
2020/ETH00725

Summary
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
Trial website
https://www.neonatalcovid19study.com
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101894 0
Dr Javeed Travadi
Address 101894 0
NICU, John Hunter Children's Hospital
2 Lookout Road
New Lambton Hts
NSW 2305
Country 101894 0
Australia
Phone 101894 0
+61 2 4921 3000
Fax 101894 0
Email 101894 0
javeed.travadi@health.nsw.gov.au
Contact person for public queries
Name 101895 0
Dr Javeed Travadi
Address 101895 0
NICU, John Hunter Children's Hospital
2 Lookout Road
New Lambton Hts
NSW 2305
Country 101895 0
Australia
Phone 101895 0
+61 2 4921 3000
Fax 101895 0
Email 101895 0
javeed.travadi@health.nsw.gov.au
Contact person for scientific queries
Name 101896 0
Dr Javeed Travadi
Address 101896 0
NICU, John Hunter Children's Hospital
2 Lookout Road
New Lambton Hts
NSW 2305
Country 101896 0
Australia
Phone 101896 0
+61 2 4921 3000
Fax 101896 0
Email 101896 0
javeed.travadi@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Beginning 3 months following main results publication; no end date determined
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Access subject to approvals by Principal Investigators
Javeed.Travadi@health.nsw.gov.au
j.oei@unsw.edu.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results