None listed
Conditions
Brief summary
Acute Respiratory Illness is the most common cause of acute presentations and hospitalisations of young Indigenous children in Australia and New Zealand. Parental smoking is a significant and preventable source of childhood morbidity, especially related to respiratory illness. Rates of adult smoking amongst Indigenous Australians and Maori are much higher compared with non-Indigenous populations; consequently Indigenous infants in both countries have higher rates of exposure to environmental tobacco smoke (ETS), compared with non-Indigenous children. The aim of this study is to trial the effect of a family-centred tobacco control program about ETS on the respiratory health of Indigenous infants up to 12 months of age.
Interventions
The ‘intervention’ is a family-centred tobacco control program which will (i) provide education about the health effects of ETS exposure and use behavioural ‘coaching’ techniques to help mothers implement strategies to reduce the infant’s ETS exposure, as well as ii) identify mothers’ and other household members’ motivation to quit smoking (if applicable) and deliver culturally appropriate smoking cessation counselling and treatment options (e.g. nicotine replacement therapy) as requested. The p
The ‘intervention’ is a family-centred tobacco control program which will (i) provide education about the health effects of ETS exposure and use behavioural ‘coaching’ techniques to help mothers implement strategies to reduce the infant’s ETS exposure, as well as ii) identify mothers’ and other household members’ motivation to quit smoking (if applicable) and deliver culturally appropriate smoking cessation counselling and treatment options (e.g. nicotine replacement therapy) as requested. The program will be led by Indigenous Health Workers and it will be delivered at three face-to-face home visits conducted over the first three months of the infant’s life.
Sponsors
Menzies School of Health Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
0 to 5 Weeks
Healthy volunteers
Yes
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.
Outcome results
None listed