NCT01304914

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 Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2010

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

4.3 years

First QC Date

February 25, 2011

Last Update Submit

March 30, 2016

Conditions

Respiratory Tract InfectionsGastrointestinal Infections

Keywords

Respiratory tract infectionsGastrointestinal tract infectionsPediatricsSpecimen collection

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    2 years

  • Detection of novel pathogens in healthy children in the first 2 years of life.

    2 years

Study Arms (1)

Healthy, term-delivered babies

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Healthy, term-delivered babies

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Brisbane and Women's Hospital

Brisbane, Queensland, 4029, Australia

Location

Northwest Private Hospital

Everton Park, Queensland, 4053, Australia

Location

Related Publications (6)

  • 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.

    PMID: 40208931DERIVED

  • 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.

    PMID: 36223234DERIVED

  • 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.

    PMID: 31406985DERIVED

  • 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.

    PMID: 29149283DERIVED

  • 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.

    PMID: 27580059DERIVED

  • 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.

    PMID: 23117571DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Parent-collected anterior-nasal swabs Nappy swabs

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Keith Grimwood, MD

    The University of Queensland

    PRINCIPAL INVESTIGATOR

  • Theo P Sloots, PhD

    The University of Queensland

    PRINCIPAL INVESTIGATOR

  • Michael D Nissen, FRACP

    The University of Queensland

    PRINCIPAL INVESTIGATOR

  • Stephen B Lambert, PhD

    The University of Queensland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

February 25, 2011

First Posted

February 28, 2011

Study Start

August 1, 2010

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

AU(2)