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Clinical Trials/ACTRN12611001143910
ACTRN12611001143910
Completed
Phase 3

A community-based, cluster randomised controlled trial in children aged 2 to 5 years

Pharmac NZ0 sites800 target enrollmentNovember 2, 2011

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Asthma
Sponsor
Pharmac NZ
Enrollment
800
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 2, 2011
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Pharmac NZ

Eligibility Criteria

Inclusion Criteria

  • Main criteria for inclusion
  • ECE centres will be eligible for inclusion in this trial if they are located within areas of high deprivation within the Waitemata district (defined as the Ministry of Education Northern Region boundary); if they are on the Ministry of Education 1st July 2010 roll and enrol 2\-5 year olds.
  • Children will be eligible for inclusion in this trial if they are aged between 2 and 4 years 8 months years at the time of enrolment into the study; if they have previously received a diagnosis of asthma from a medical practitioner; if they attend one of the participating ECE centres; and if informed consent has been obtained from the child’s guardian/caregiver.

Exclusion Criteria

  • ECE centres will be excluded from the trial if they are located outside the Waitemata district (defined as the Ministry of Education Northern Region boundary); if they are not on the Ministry of Education 1st July 2010 roll; or if they enrol 0\-2 year olds only.
  • Children will be excluded from the trial if they are younger than 2 or older than 4 years 8 months at the time of enrolment; if they have a respiratory illness other than asthma, as diagnosed by a medical practitioner; if they have previously been assessed by a GASP nurse, using the GASP tool; if they are enrolled or attending another ECE centre or if they are currently enrolled in another respiratory\-based research study.

Outcomes

Primary Outcomes

Not specified

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