A randomised controlled trial of a family-centred tobacco control program about environmental tobacco smoke (ETS) to reduce respiratory illness in Indigenous infants.

Menzies School of Health Research0 个研究点目标入组 420 人开始时间: 2009年11月2日最近更新: 2020年1月13日

试验速览

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•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.

•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.

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