Observational Research in Childhood Infectious Diseases Study (ORChID)
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ClinicalTrials.gov Identifier: NCT01304914 |
Recruitment Status :
Completed
First Posted : February 28, 2011
Last Update Posted : March 31, 2016
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Condition or disease |
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Respiratory Tract Infections Gastrointestinal Infections |

Study Type : | Observational |
Actual Enrollment : | 165 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Prospective, Community-based, Longitudinal Dynamic Birth Cohort Study of Respiratory and Gastrointestinal Pathogen Identification in Brisbane Infants. |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | November 2014 |
Actual Study Completion Date : | November 2014 |
Group/Cohort |
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Healthy, term-delivered babies |
- 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.
- 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 ]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.
- Detection of novel pathogens in healthy children in the first 2 years of life. [ Time Frame: 2 years ]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.
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 7 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304914
Australia, Queensland | |
Royal Brisbane and Women's Hospital | |
Brisbane, Queensland, Australia, 4029 | |
Northwest Private Hospital | |
Everton Park, Queensland, Australia, 4053 |
Principal Investigator: | Keith Grimwood, MD | Queensland Children's Medical Research Institute | |
Principal Investigator: | Theo P Sloots, PhD | Queensland Children's Medical Research Institute | |
Principal Investigator: | Michael D Nissen, FRACP | Queensland Children's Medical Research Institute | |
Principal Investigator: | Stephen B Lambert, PhD | Queensland Children's Medical Research Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr Stephen Lambert, Senior Research Fellow, Queensland Children's Medical Research Institute |
ClinicalTrials.gov Identifier: | NCT01304914 History of Changes |
Other Study ID Numbers: |
HREC10/QRCH16 |
First Posted: | February 28, 2011 Key Record Dates |
Last Update Posted: | March 31, 2016 |
Last Verified: | March 2016 |
Respiratory tract infections Gastrointestinal tract infections Pediatrics Specimen collection |
Infection Communicable Diseases Respiratory Tract Infections Respiratory Tract Diseases |