None listed
Conditions
Brief summary
This is a randomised controlled study enrolling 240 children to either ‘intervention’ or ‘control’ groups. The aim of this research is to trial a programme of safe sleep using cots, pepi-pods and wahakura infant sleep devices as a way of making knowledge of safe sleep tangible and accessible to Maori and Pacific families. This trial will ascertain if this safe sleep programme is effective and useful for this population of high risk infants. Participants (n=240) will be randomised 1:1 to either an intervention group to receive a safe sleep programme and Infant sleep device or a control group to receive current safe sleep education and support through maternity, well child and primary care providers. All children will have an initial assessment and will have follow up visits to the age of 6 months. Risk factors for SUDI are well documented and have resulted in an overall reduction of SUDI. However this reduction has not been seen for Maori and Pacific (Mitchell, Hutchison, Stewart, 2007) particularly in South Auckland where there are 10-15 SUDI per year. It is well documented that infants suffering SUDI are not sleeping safely (Hutchison et al, 2011). There is a need for a safe sleep space whatever the circumstances and particularly for the peak risk period of 0-4 months. There is a need for intensive education about safe sleep and infant sleep devices. In particular management of babies whose behaviour, health and family circumstances compromise the ability to put the infant to sleep safely (e.g. reflux, respiratory illness etc). “Change for our Children” (CFOC) under a ministry of health contract has established an infant sleep device the pepi-pod embedded in a “baby essentials” safe to sleep programme with support from the designers of the wahakura. This research will test if this infant sleep devices (ISD) programme is acceptable and successful for the CMDHB population. If acceptable and successful it is anticipated there will be major improvement in safe infant sleeping for high risk infants. The qualitative research will engage local Maori in developing collective solutions for safe infant sleep for Maori infants. The research nurses will work in close liaison with the newly established safe sleep co-ordinator position and the Baby Friendly Hospital Initiative (BFHI) Educator. Hypothesis: That the provision of an infant sleep devices (ISD) programme is acceptable and effective at improving knowledge and sleep practice for high risk Maori and Pacific populations in South Auckland.
Interventions
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 sharin
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.
Sponsors
Middlemore Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Hours to No maximum
Healthy volunteers
Yes
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.
Exclusion criteria
* Chronic illness or disability affecting daily life * Current provision of apnoea alarm * Unsafe home environment for research staff e.g. unsafe gang house. * Unable to consent due to language barriers
Outcome results
None listed