Respiratory Tract InfectionsORChIDNCT01304914
Observational Research in Childhood Infectious Diseases Study
An observational study of Respiratory Tract Infections and Gastrointestinal Infections, run by The University of Queensland at 2 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Respiratory Tract Infections, Gastrointestinal Infections
- How many people
- 165 participants
- Where
- 2 sitesAustralia
- Study dates
- Aug 2010to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy, term-delivered babies
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Northwest Private Hospital
Everton Park, Queensland, 4053
About this study
Official title: Prospective, Community-based, Longitudinal Dynamic Birth Cohort Study of Respiratory and Gastrointestinal Pathogen Identification in Brisbane Infants.
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.
Read the detailed description
This will be a prospective, community-based longitudinal birth cohort study of respiratory and gastrointestinal pathogen detection in Brisbane infants. The enrollment target of 138 children will take 2 years to achieve, each child will be followed until their second birthday, and a final year will be required for specimen and data analysis; for a total duration of the study of 5 years.
Women are to be recruited antenatally over a period of two years from study commencement (mid-2010). These hospitals serve communities from the north of Brisbane, a city of almost 2 million people, and every year each has roughly 5,200 (RBWH) and 1,700 (North West) annual deliveries respectively. The investigators will follow 138 infants from birth until their second birthday. Where a family drops out of the study or is lost to follow-up, they will be replaced to maintain overall person-time for the study.
The progressive 2 year recruitment plan allows for seasonal and year-to-year variation in respiratory virus activity. Eligible infants will be healthy term babies without conditions that predispose to more frequent or severe infectious episodes.
Parents will keep a simple, daily, infection symptom diary, completed using tick boxes and numbers, which the investigators will request be returned on a 4-weekly basis. A similar diary was used for a 12-month cohort study conducted in Melbourne (2003-2004) with excellent return rate and acceptability by study families.
Study families are to be contacted monthly by their preferred method of communication (telephone, SMS, or email) to encourage continued performance of study tasks and answer study related questions.
Parents will be asked to identify acute respiratory illness (ARI) and acute gastroenteritis (AGE) in study children. These are defined as:
- ARI: presence of at least one yellow OR at least two blue symptoms on a single day; and
- AGE: three or more watery or looser-than-normal stools OR vomiting on a single day.
When an ARI or AGE occur, parents will be asked to complete an impact diary for the duration of illness. Parents will be asked to contact us in the event of hospitalisation due to any cause. Parents will be asked to provide consent for hospital/GP release of information to allow study staff to collect details of episodes of care.
Cord blood will also be collected at birth and stored for later identification of pathogen-specific antibodies and immune mediators linked to disease susceptibility. A respiratory and stool swab will be collected from study neonates within one day of birth. At this visit, the investigators will collect a respiratory swab from the parent/s of the child - this will allow us to compare presence of pathogens in the neonate and parents, and will be the only time parents will be swabbed. Parents will be trained in the process of collecting the study swabs at this visit. All material and instructions required for this process will be provided to parents at no cost. Telephone and visiting support to assist and guide specimen collection will be available for study parents at all stages during the study.
Parents will be asked to routinely collect two specimens on the same day of the week as the initial visit, weekly until the end of the study. The specimens are:
- a combined anterior nares swab, collected from both nostrils using a single, rayon-budded swab. The swab comes with its own transport tube containing a VTM-soaked sponge in the base. The completed swab is placed in the transport tube and the VTM sponge is squeezed to bath the swab; and
- a stool swab from a dirty nappy, collected and handled using the swab similar to the anterior nares swab.
Both swabs are mailed back to Qpid Laboratory as soon as possible after collection, using pre-addressed, reply post, padded envelopes.
All specimens will be batch tested for a variety of pathogens using validated PCR methods developed at Qpid. Samples from children with ARI or AGE for whom a known agent cannot be identified, will be made available for further investigations for the presence of as yet unidentified viruses.
- Keywords
- Respiratory tract infections, Gastrointestinal tract infections, Pediatrics, Specimen collection
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy, term-delivered babies | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
This measure will be calculated using counts of ARIs and AGE in study children during the first two years of life as the numerator, and person-time in child-months on the study as the denominator.
Measured: Two years
Secondary outcomes (2)
Pathogen-specific rate of episodes of ARI and AGE per 10,000 child-days in healthy children in the first two years of life
Viral and bacterial testing will allow to calculate pathogen-specific rates: This measure will be calculated using counts of pathogen-specific ARIs and AGE in study children during the first two years of life as the numerator, and person-time in child-months on the study as the denominator.
Measured: 2 years
Detection of novel pathogens in healthy children in the first 2 years of life.
A subset of samples collected during this study will be used to attempt to identify previously undetected pathogens in children, through microarray technology and random primer PCR testing.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startAug 2010
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brisbane and Women's Hospital
- Responsible party
- Principal investigator, Dr Stephen Lambert, The University of Queensland
- Investigators
- Keith Grimwood, MD, Principal investigator, The University of QueenslandTheo P Sloots, PhD, Principal investigator, The University of QueenslandMichael D Nissen, FRACP, Principal investigator, The University of QueenslandStephen B Lambert, PhD, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304914
- Sponsor's protocol ID
- HREC10/QRCH16
- Acronym
- ORChID
- Status last verified
- Mar 2016
- First submitted
- 25 Feb 2011
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Saha S, Fozzard N, Grimwood K, Lambert SB, Ware RS. The Ages When Healthy Children Are First Colonized by Three Common Potentially Pathogenic Bacteria: A Birth Cohort Study. Pediatr Infect Dis J. 2025 Apr 3;44(9):907-909. doi: 10.1097/INF.0000000000004798.
PubMed 40208931El-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.
PubMed 36223234Wang 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.
PubMed 31406985Ye 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.
PubMed 29149283Sarna 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.
PubMed 27580059Lambert 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.
PubMed 23117571
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Community-based, Longitudinal Dynamic Birth Cohort Study of Respiratory and Gastrointestinal Pathogen Identification in Brisbane Infants.
- ClinicalTrials.gov ID
- NCT01304914
- Acronym / sponsor ID
- ORChID / HREC10/QRCH16
- Keywords
- Respiratory tract infections, Gastrointestinal tract infections, Pediatrics, Specimen collection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Royal Brisbane and Women's Hospital
- Study start
- Aug 2010
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a prospective, community-based longitudinal birth cohort study of respiratory and gastrointestinal pathogen detection in Brisbane infants. The enrollment target of 138 children will take 2 years to achieve, each child will be followed until their second birthday, and a final year will be required for specimen and data analysis; for a total duration of the study of 5 years.
Women are to be recruited antenatally over a period of two years from study commencement (mid-2010). These hospitals serve communities from the north of Brisbane, a city of almost 2 million people, and every year each has roughly 5,200 (RBWH) and 1,700 (North West) annual deliveries respectively. The investigators will follow 138 infants from birth until their second birthday. Where a family drops out of the study or is lost to follow-up, they will be replaced to maintain overall person-time for the study.
The progressive 2 year recruitment plan allows for seasonal and year-to-year variation in respiratory virus activity. Eligible infants will be healthy term babies without conditions that predispose to more frequent or severe infectious episodes.
Parents will keep a simple, daily, infection symptom diary, completed using tick boxes and numbers, which the investigators will request be returned on a 4-weekly basis. A similar diary was used for a 12-month cohort study conducted in Melbourne (2003-2004) with excellent return rate and acceptability by study families.
Study families are to be contacted monthly by their preferred method of communication (telephone, SMS, or email) to encourage continued performance of study tasks and answer study related questions.
Parents will be asked to identify acute respiratory illness (ARI) and acute gastroenteritis (AGE) in study children. These are defined as:
- ARI: presence of at least one yellow OR at least two blue symptoms on a single day; and
- AGE: three or more watery or looser-than-normal stools OR vomiting on a single day.
When an ARI or AGE occur, parents will be asked to complete an impact diary for the duration of illness. Parents will be asked to contact us in the event of hospitalisation due to any cause. Parents will be asked to provide consent for hospital/GP release of information to allow study staff to collect details of episodes of care.
Cord blood will also be collected at birth and stored for later identification of pathogen-specific antibodies and immune mediators linked to disease susceptibility. A respiratory and stool swab will be collected from study neonates within one day of birth. At this visit, the investigators will collect a respiratory swab from the parent/s of the child - this will allow us to compare presence of pathogens in the neonate and parents, and will be the only time parents will be swabbed. Parents will be trained in the process of collecting the study swabs at this visit. All material and instructions required for this process will be provided to parents at no cost. Telephone and visiting support to assist and guide specimen collection will be available for study parents at all stages during the study.
Parents will be asked to routinely collect two specimens on the same day of the week as the initial visit, weekly until the end of the study. The specimens are:
- a combined anterior nares swab, collected from both nostrils using a single, rayon-budded swab. The swab comes with its own transport tube containing a VTM-soaked sponge in the base. The completed swab is placed in the transport tube and the VTM sponge is squeezed to bath the swab; and
- a stool swab from a dirty nappy, collected and handled using the swab similar to the anterior nares swab.
Both swabs are mailed back to Qpid Laboratory as soon as possible after collection, using pre-addressed, reply post, padded envelopes.
All specimens will be batch tested for a variety of pathogens using validated PCR methods developed at Qpid. Samples from children with ARI or AGE for whom a known agent cannot be identified, will be made available for further investigations for the presence of as yet unidentified viruses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy, term-delivered babies | – | – |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy, term-delivered babies
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: Two years
This measure will be calculated using counts of ARIs and AGE in study children during the first two years of life as the numerator, and person-time in child-months on the study as the denominator.
2 secondary outcomes
Pathogen-specific rate of episodes of ARI and AGE per 10,000 child-days in healthy children in the first two years of life
Time frame: 2 years
Detection of novel pathogens in healthy children in the first 2 years of life.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Derived from this study: PubMed 40208931Saha S, Fozzard N, Grimwood K, Lambert SB, Ware RS. The Ages When Healthy Children Are First Colonized by Three Common Potentially Pathogenic Bacteria: A Birth Cohort Study. Pediatr Infect Dis J. 2025 Apr 3;44(9):907-909. doi: 10.1097/INF.0000000000004798.
- Derived from this study: PubMed 36223234El-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.
- Derived from this study: PubMed 31406985Wang 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.
- Derived from this study: PubMed 29149283Ye 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.
- Derived from this study: PubMed 27580059Sarna 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.
- Derived from this study: PubMed 23117571Lambert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith Grimwood, MD principal investigator
The University of Queensland
Theo P Sloots, PhD principal investigator
The University of Queensland
Michael D Nissen, FRACP principal investigator
The University of Queensland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tract Infections and Gastrointestinal Infections, run by The University of Queensland at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01304914, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.