Observational Research in Childhood Infectious Diseases Study (ORChID)

This study has been completed.

Sponsor:

Collaborator:

Royal Brisbane and Women's Hospital

Information provided by (Responsible Party):

Dr Stephen Lambert, Queensland Children's Medical Research Institute

ClinicalTrials.gov Identifier:

NCT01304914

First received: February 25, 2011

Last updated: March 30, 2016

Last verified: March 2016

History of Changes

Purpose

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.

Condition
Respiratory Tract Infections Gastrointestinal Infections


Study Type:	Observational
Study Design:	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.

Further study details as provided by Queensland Children's Medical Research Institute:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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

Parent-collected anterior-nasal swabs Nappy swabs


Enrollment:	165
Study Start Date:	August 2010
Study Completion Date:	November 2014
Primary Completion Date:	November 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
Healthy, term-delivered babies

Show Detailed Description

Eligibility


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

Study Population

Healthy, term-delivered babies

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304914

Locations


Australia, Queensland
Royal Brisbane and Women's Hospital
Brisbane, Queensland, Australia, 4029
Northwest Private Hospital
Everton Park, Queensland, Australia, 4053

Sponsors and Collaborators

Queensland Children's Medical Research Institute

Royal Brisbane and Women's Hospital

Investigators


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

More Information


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
Study First Received:	February 25, 2011
Last Updated:	March 30, 2016
Health Authority:	Australia: National Health and Medical Research Council

Keywords provided by Queensland Children's Medical Research Institute:


Respiratory tract infections Gastrointestinal tract infections Pediatrics Specimen collection

Additional relevant MeSH terms:


Infection Communicable Diseases Respiratory Tract Infections Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 30, 2016

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