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A cluster-randomised study of mask use in control of influenza or other respiratory virus transmission within the family with at least two adults and only one ill child

A cluster-randomised study of mask use in control of influenza or other respiratory virus transmission within the family with at least two adults and only one ill child.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000183482
Enrollment
286
Registered
2007-03-27
Start date
2006-10-09
Completion date
2008-08-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is a prospective, 3-armed cluster-randomised trial to determine the effect of the use of two different kinds of face masks on the transmission of influenza and other respiratory viruses. The starting point will be patients with influenza-like illness (ILI), whose households will then become the focus of the study. Index cases with ILI will be identified using the emergency department of the Children's Hospital at Westmead and their families will be approached to give their consent. In two arms of the study, adult contacts in the household will be provided with one of two types of face mask (surgical masks or P2 masks) to be worn when in the same room as the index case. Families in the third arm of the study will receive only education about infection control. Several measures will be used to measure compliance, including observation by family members within the household, self report through the use of diary cards, and interviews with a random selection of participants. There will be two main outcomes: ILI and laboratory diagnosis of influenza or other respiratory viruses (as determined from nasopharyngeal swabs and blood samples), and impact on influenza transmission within the household.

Interventions

Families will be divided into three groups for the study. Group one and two are the intrevention groups and group three is the control group. Group 1: adults in the family will receive surgical masks for use while in the same room as the sick child. Group 2: adults in the family will wear P2 masks while in the same room as the sick child. The P2 masks , is a facial mask which protects against airborne micro-organisms.

Sponsors

National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 15 Years
Healthy volunteers
No

Inclusion criteria

1) The child is the first and only person ill in the family and 2) The child lives with at least two adults at home.3) The childs aged between 0 to 15 years4) The adults can be anyone over the age of 16 years.

Exclusion criteria

1) Inability or refusal to consent 2) Child’s admission to hospital3) Residing in household with less than two adults 4) Other family members who have been ill in the 2 weeks prior to or simultaneous to the child.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026