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Trial registered on ANZCTR


Registration number
ACTRN12616001427460
Ethics application status
Approved
Date submitted
4/08/2016
Date registered
13/10/2016
Date last updated
13/10/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
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.
Secondary ID [1] 289847 0
nil Known
Universal Trial Number (UTN)
NA
Trial acronym
SUDI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sudden unexpected death in children (SUDI) 299787 0
Condition category
Condition code
Public Health 299715 299715 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.


Intervention code [1] 295528 0
Treatment: Devices
Intervention code [2] 295936 0
Prevention
Comparator / control treatment
The control group of 120 will receive routine safe sleep education and support through their usual healthcare providers. In addition a cot will be provided to families who do not have access to one and if unsafe sleep is observed then the family will be given additional safe sleep advice and referred to their usual healthcare provider.. The knowledge and sleep practice questionnaire will be administered by research staff (CHW's) at enrolment, 2 months and 4 months of age in the home environment.
Control group
Active

Outcomes
Primary outcome [1] 299167 0
*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.
Timepoint [1] 299167 0
* baseline < 2 weeks of age
* 2 Months post natal age
* 4 months post natal age
Primary outcome [2] 299227 0
*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.
Timepoint [2] 299227 0
* 2 Months post commencement of safe sleep programme
* 4 months post commencement of safe sleep programme
Primary outcome [3] 299853 0
* 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.
Timepoint [3] 299853 0
*2 months
*4 months
Secondary outcome [1] 326565 0
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.
Timepoint [1] 326565 0
* 14 days post commencement of safe sleep programme
* 2 Months post commencement of safe sleep programme
* 4 months post commencement of safe sleep programme
Secondary outcome [2] 326566 0
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.
Timepoint [2] 326566 0
* 4 months post natal age

Eligibility
Key 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.
Minimum age
1 Hours
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated central randomisation, in blocks, sealed in an opaque envelope. The community health researchers take consecutive envelopes when attending a home visit.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample Size Determinations: 240 children will be randomised 1:1 to intervention and control groups. 120 in each group will provide 80% power to detect a difference in % not safe sleeping, at the 5% level of significance if 30% don’t safe sleep without an ISD and 15% with. There are 115,500 children 0-14 years of age (census 2006) in CMDHB with, 24% Maaori, 28% Pacific, 15% Asian and 33% Other. Approximately 3600 infants are born each year in decile 9 and 10, in CMDHB, of this group 1200 are Maaori and 2400 are Pacific.

Analysis: Frequency tables with percentages will be presented with their 95% CI for knowledge, practice and opinions of the intervention group and will compare knowledge and practice of the 2 groups using logistic regression including confounders such as age, education and deprivation.

Qualitative Analysis: The study will utilise a qualitative analysis framework designed by Pope, Ziebland and Mays (2000). This is a five step process that includes the following steps: familiarisation, identification of a thematic framework, indexing, charting, mapping and interpreting. The use of this thematic framework will allow for an audit path to be achieved, to ensure validity and reliability are maintained.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8077 0
New Zealand
State/province [1] 8077 0
Auckland

Funding & Sponsors
Funding source category [1] 294225 0
Charities/Societies/Foundations
Name [1] 294225 0
Cure Kids
Address [1] 294225 0
Level 1, 96 New North Road
Eden Terrace 1021
Auckland
Country [1] 294225 0
New Zealand
Primary sponsor type
Hospital
Name
Middlemore Hospital
Address
100 Hospital Rd
Papatoetoe
Auckland 2025
Country
New Zealand
Secondary sponsor category [1] 293057 0
None
Name [1] 293057 0
None
Address [1] 293057 0
Country [1] 293057 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295647 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 295647 0
Ministry of Health
P.O.Box 5013
Wellington 6011
Ethics committee country [1] 295647 0
New Zealand
Date submitted for ethics approval [1] 295647 0
02/04/2012
Approval date [1] 295647 0
15/06/2012
Ethics approval number [1] 295647 0
NTX/11/12/113

Summary
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.



Trial website
Trial related presentations / publications
Conference presentations are as follows:
1. McIntosh C, Trenholme A, Stewart J, Tonkin S. A randomised controlled study of an innovative sleep intervention for the prevention of Sudden Unexpected Death in Infancy, in high risk Maori and Pacific Infants, in South Auckland New Zealand. ISA and ISPID Joint Conference, Amsterdam Sept 2014.
2. Nicholls E, Day K, McIntosh CG, Trenholme A. ‘Bridging the gap’ – overcoming the barriers to effective engagement with families at higher Sudden Unexpected Death in Infancy risk. ISA and ISPID Joint Conference, Amsterdam Sept 2014.
Public notes

Contacts
Principal investigator
Name 68006 0
Dr Adrian Trenholme
Address 68006 0
Kidz First Middlemore Hospital
100 Hospital Rd
Papatoetoe
Auckland 2025
Country 68006 0
New Zealand
Phone 68006 0
+64 9 2760000
Fax 68006 0
Email 68006 0
a.trenholme@middlemore.co.nz
Contact person for public queries
Name 68007 0
Dr Adrian Trenholme
Address 68007 0
Kidz First Middlemore Hospital
100 Hospital Rd
Papatoetoe
Auckland 2025
Country 68007 0
New Zealand
Phone 68007 0
+64 9 2760000
Fax 68007 0
Email 68007 0
a.trenholme@middlemore.co.nz
Contact person for scientific queries
Name 68008 0
Dr Christine McIntosh
Address 68008 0
Kidz First Middlemore Hospital
100 Hospital Rd
Papatoetoe
Auckland 2025
Country 68008 0
New Zealand
Phone 68008 0
+64 9 2760000
Fax 68008 0
Email 68008 0
c.mcintosh@middlemore.co.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary