Evaluation of an Innovative Sleep Intervention for the Prevention of Sudden Unexpected Death in Infancy in a cohort of Maori and Pacific Infants in South Auckland New Zealand.

INTERVENTION: A randomised controlled study enrolling 240 mothers and their infants to either ‘intervention’ or ‘control’ group. The intervention group of 120 participants will receive the Change for our Children Pepi‐pod safe sleep programme including a Pepi‐pod safe sleep device which is a baby bed of polypropylene box construction with mattress, cotton sheets and a merino wool blanket. Intervention group will be encouraged to use the Pepi‐pod especially and in place of taking their baby into the bed sharing situation.(1) Decision on whether to use the Pepi‐pod, duration and mode of use will be determined by the family choice after receiving the safe sleep programme education. The Pepi‐pod safe sleep programme will be provided by research Community Health Workers (CHWs) credentialed, by Change for Our Children. The programme will be delivered face to face in the participant’s home in the Change for Our Children programme format covering the Safety Briefing Checklist, but allowing for the research consent and follow‐up and will take a minimum of 30 minutes. (2)) The CHWs will check‐in with parents by phone after 2 weeks (approximately 5 minute duration) to assess initial acceptability, address any concerns and measure knowledge diffusion with standard Pepi‐pod safe sleep programme brief questionnaire as described in the Pepi‐pod safe sleep programme.(1) Programme fidelity will be checked by one of the clinical researchers by use of the Competency Checklist. (3) This will be done in an initial visit then again at approximately half way through recruitment. Competency will be discussed and recommendations made to the CHR delivering the programme. The intervention therefore covers additional education with Pepi‐pod provision at baseline and follow‐up 2 weeks later. Intervention group will have additional questionnaire questions at 2 and 4 months follow up. The control group of 120 participants will receive the standard established safe sleep education and support through maternity, well child and primary care providers. All participants will require participation from recruitment at less than 2 weeks age up until completion of the 4 months of age questionnaire. A portable cot will be provided to families, both intervention and control, who do not have access to a safe cot, as a requirement of ethical approval. Study staff will remain in contact with local health providers. Acceptability to families is ascertained by the Pepi‐pod questionnaire developed and used by Change for Our Children the developers of the Pepi‐pod safe sleep programme. Content of discussion by the CHW during the education session with pepi‐pod. Why we are doing this; *Demonstrate how babies breathe and how they can suffocate and why back sleeping is protective. *Explain why the baby being visited is more vulnerable. *Explain which positions, locations and situations increase risk. How to use a Pepi‐pod sleep space: *Assemble the pepi‐pod while explaining the safety features of each item in the package. *Go through the “rules of protection” on the information card and other principles of protection. *Explain the ‘spread the word” expectation for sharing information with others. Where to put the pepi‐pod sleep space *Demonstrate how the pepi‐pod sleep space can be used to help settle babies and build sleep habits. *Explain when a pepi‐pod sleep space must always be used ( when babies sleep in or on an adult bed, on a couch, in makeshift situations or when away from a baby’s normal place of sleep.) *Demonstrate safe placement of the Pepi‐pod sleep space especially when used on a adult bed, mattress , on floors and around toddlers. Paperwork *Go trough Terms and Conditions and invite and respond to questions. *Complete distribution information. References: 1. Change for Our Children. The Pepi‐pod Safe Sleep Programme. Report on the 2012 distribution and use of portable spaces for promoting safe sleep for more vulnerable babies. Christchurch, New Zealand: Change for Our Children; 2013. 2. Safety Briefing Checklist. Change for Our Children. www.changeforourchildren.co.nz/pepi_pod_programme/distrubutors. Last accessed 03/10/16. 3. Competency Checklist. Change for Our Children. www.changeforourchildren.co.nz/pepi_pod_programme/distributors. Last accessed 03/10/16. CONDITION: Sudden unexpected death in children (SUDI) PRIMARY OUTCOME: * Difference in infant care practices (bed sharing, breastfeeding, smoking, room sharing, sleep positioning) intervention vs control groups. ; This will be measured by a follow up questionnaire at 2 and 4 months. Questions were constructed with a combination of validated questions from The NZ SUDI study and KISS Study (permission by authors) and new questions designed specifically for this study to gain clarity about bed‐sharing and changes in bed sharing during the night. *Composite primary outcome ‐ Pepi‐pod acceptability: ; ; Acceptability of the pepi‐pod as measured by frequency of use and parental report of usefulness and significant difference in SUDI protective knowledge and infant care practices at follow up compared with control. ; Assessment by A Knowledge and Sleep Practice questionnaire specifically designed for the study that has not yet been validated. This will be administered at Baseline (prior to randomisation and delivery of intervention), with follow up questionnaires at 2 and 4 months’ postnatal age. ; *Difference in knowledge in SUDI risk and protective factors intervention vs control groups. ; ; Document parental knowledge of risk factors after the pepi‐pod programme and compare with a control group by a face to face questionnaire. This information is self‐reported by participants on study‐designed questionnaire, based on knowledge questions of the South Auckland Phone Survey Tipene‐Leach 2010. INCLUSION CRITERIA: All Maaori or Pacific families with an infant under 2 weeks of age resident in CMDHB who are living in decile 9 and 10 areas with a history of smoke exposure in utero and or in the environment. SECONDARY OUTCOME: Acceptability: as measured by agreement to continue using the pepi‐pod and by direct questioning using the pepi‐pod questionnaire of usefulness, frequency of use and situations used. The pepi‐pod questionnaire has been designed for the study. Qualitative Sub‐study: Maaori families in the randomised control trial will be approached in order of enrolment until 20 families have agreed. This phase of the research will include semi‐structured face‐to‐face interviews with the 20 parents or caregivers of those infants. A paediatric research nurse and Maaori health worker, trained in qualitative interviews will conduct the semi‐structured interviews, which will then be audio‐taped and transcribed. The interviews will explore perceptions about what contributes to safe sleeping for Maaori whanau, and ways the community may be able to ensure all Maaori infants sleep safely.