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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01304914




Registration number
NCT01304914
Ethics application status
Date submitted
25/02/2011
Date registered
28/02/2011
Date last updated
31/03/2016

Titles & IDs
Public title
Observational Research in Childhood Infectious Diseases Study
Scientific title
Prospective, Community-based, Longitudinal Dynamic Birth Cohort Study of Respiratory and Gastrointestinal Pathogen Identification in Brisbane Infants.
Secondary ID [1] 0 0
HREC10/QRCH16
Universal Trial Number (UTN)
Trial acronym
ORChID
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Tract Infections 0 0
Gastrointestinal Infections 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Healthy, term-delivered babies -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Acute respiratory illness (ARIs) and acute gastrointestinal (AGE) illness rates per 10,000 child-days in healthy children in the first two years of life
Timepoint [1] 0 0
Two years
Secondary outcome [1] 0 0
Pathogen-specific rate of episodes of ARI and AGE per 10,000 child-days in healthy children in the first two years of life
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Detection of novel pathogens in healthy children in the first 2 years of life.
Timepoint [2] 0 0
2 years

Eligibility
Key inclusion criteria
* pregnant women expecting to deliver a healthy, term baby
* written informed consent from pregnant woman who is available for telephone contact for the duration of the study, and not planning to move out of the study area
* parent willing to collect a weekly anterior nasal specimen and stool (nappy) specimen from the study child and return to study site via mail
* parent or guardian with sufficient English language skills to complete study diaries and perform study tasks as required
Minimum age
No limit
Maximum age
7 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* children born before 36 weeks
* children with chronic pulmonary or cardiovascular disorders
* children with chronic metabolic disorders (such as, but not limited to, diabetes mellitus, renal dysfunction, haemoglobinopathies)
* children with immune system disorders (such as HIV/AIDS or receiving immune system suppressing medications)
* children with other chronic illnesses whose enrollment is deemed by the investigators to make it inappropriate to enroll them onto, or to continue in, the study

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2014
Sample size
Target
Accrual to date
Final
165
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
Northwest Private Hospital - Everton Park
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
4053 - Everton Park

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
Royal Brisbane and Women's Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
In this study, the investigator will be approaching pregnant women to undertake 2 years of weekly respiratory and nappy specimen collection from their healthy new born infant. These specimens will be mailed to the Queensland Paediatric Infectious Diseases (Qpid) Laboratory where they will be stored and batched tested for viruses and bacteria. As well as this, parents will keep a simple daily symptom diary for their child, allowing us to match detection of viruses and bacteria to periods when the study child did or did not have symptoms. This will help our understanding of what finding these viruses and bacteria in specimens from children really means.
Trial website
https://clinicaltrials.gov/study/NCT01304914
Trial related presentations / publications
El-Heneidy A, Grimwood K, Mihala G, Lambert S, Ware RS. Epidemiology of Norovirus in the First 2 Years of Life in an Australian Community-based Birth Cohort. Pediatr Infect Dis J. 2022 Nov 1;41(11):878-884. doi: 10.1097/INF.0000000000003667. Epub 2022 Oct 11.
Wang CYT, Ware RS, Lambert SB, Mhango LP, Tozer S, Day R, Grimwood K, Bialasiewicz S. Parechovirus A Infections in Healthy Australian Children During the First 2 Years of Life: A Community-based Longitudinal Birth Cohort Study. Clin Infect Dis. 2020 Jun 24;71(1):116-127. doi: 10.1093/cid/ciz761.
Ye S, Whiley DM, Ware RS, Kirkwood CD, Lambert SB, Grimwood K. Multivalent Rotavirus Vaccine and Wild-type Rotavirus Strain Shedding in Australian Infants: A Birth Cohort Study. Clin Infect Dis. 2018 Apr 17;66(9):1411-1418. doi: 10.1093/cid/cix1022.
Sarna M, Alsaleh A, Lambert SB, Ware RS, Mhango LP, Mackay IM, Whiley DM, Sloots TP, Grimwood K. Respiratory Viruses in Neonates: A Prospective, Community-based Birth Cohort Study. Pediatr Infect Dis J. 2016 Dec;35(12):1355-1357. doi: 10.1097/INF.0000000000001316.
Lambert SB, Ware RS, Cook AL, Maguire FA, Whiley DM, Bialasiewicz S, Mackay IM, Wang D, Sloots TP, Nissen MD, Grimwood K. Observational Research in Childhood Infectious Diseases (ORChID): a dynamic birth cohort study. BMJ Open. 2012 Oct 31;2(6):e002134. doi: 10.1136/bmjopen-2012-002134. Print 2012.
Public notes

Contacts
Principal investigator
Name 0 0
Keith Grimwood, MD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01304914