Observational Research in Childhood Infectious Diseases Study (ORChID)
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ClinicalTrials.gov Identifier: NCT01304914
: February 28, 2011
Last Update Posted
: March 31, 2016
Queensland Children's Medical Research Institute
Royal Brisbane and Women's Hospital
Information provided by (Responsible Party):
Dr Stephen Lambert, Queensland Children's Medical Research Institute
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.
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.
Secondary Outcome Measures
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.
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Ages Eligible for Study:
up to 7 Days (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy, term-delivered babies
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
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