A family tobacco control program to reduce respiratory illness in Indigenous infants.

Not Applicable

Completed

• Conditions: Prevention of respiratory illness among Indigenous infants; Prevention of environmental tobacco smoke exposure of Indigenous infants; Respiratory - Other respiratory disorders / diseases; Public Health - Health promotion/education

• Registration Number: ACTRN12609000937213
• Lead Sponsor: Menzies School of Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-11-02
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Infants will be eligible for inclusion if: 1. They are aged between 0-5 weeks. We will review our recruitment rate four months after the trial has commenced. If we find that we are not meeting our enrolment targets, we will consider extending our recruitment to include infants aged 5-10 weeks. This will allow us to approach mothers and their infants at 6-8 weeks when they present at community health clinics for their first immunizations. 2. Their mother/caregiver is Indigenous (defined by maternal self-identification). 3. Their mother/caregiver is aged 16 years or over. 4. Their mother/caregiver currently smokes or if the infant lives in a household where there is at least one other person who smokes (defined as smoking at least weekly). 5. Their mother/caregiver plans to reside permanently with the infant in Darwin or Greater Darwin areas of Australia or within the Counties Manukau District Health Board region, Manukau, NZ. 6. Their mother/caregiver has given signed written consent to participate in this research study. 7. Their mother/caregiver has given signed written consent for study staff to access the infant’s health records. 8. They are a singleton or the first born in a multiple pregnancy delivery. 9. Their mother/caregiver speaks English and/or Maori.

Exclusion Criteria

Infants will be excluded from the trial if:
1. They have serious neonatal respiratory complications (i.e. they require oxygen for >24 hours during their postnatal hospital stay).
2. They have other serious neonatal complications (e.g. seizures, significant sepsis).
3. They have major organ abnormalities (i.e. cardiac disease, congenital lung/diaphragm abnormalities, chromosomal abnormality or syndrome e.g. Down’s syndrome).
4. Their mother/caregiver has previously been recruited in this research study.
5. They live in the same household as a mother/caregiver who has previously been recruited in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified