Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000059460
Ethics application status
Approved
Date submitted
18/12/2015
Date registered
20/01/2016
Date last updated
20/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safe Sleep Calculator Use in Midwifery
Scientific title
Implementation of a Safe Sleep Calculator to calculate the risk of Sudden Unexpected Death (SUDI) in Infancy, to enable South Auckland midwives to identify and address SUDI risk.
Secondary ID [1] 288189 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sudden Unexpected Death in Infancy 297094 0
Condition category
Condition code
Reproductive Health and Childbirth 297332 297332 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Safe Sleep Calculator (SSC) is an online tool that has been developed by Prof. Edwin Mitchell using the risk algorithm developed by Bob Carpenter which has been based on the five large international Sudden infant Death Syndrome (SIDS) case control studies.
From December 2015 through January 2016 up to thirty South Auckland midwives will be invited to volunteer to incorporate the SSC as their method of SUDI risk assessment into routine post-natal care.
Midwives will request consent from the parent to use the SSC, to assess SUDI risk, in the the post-natal period from birth up until discharge from midwifery care at 4-6 weeks old preferably once the baby is in the home . This involves asking the mother/parent questions related to SUDI risk for example; baby's birth weight, mothers smoking status and the place and position where baby sleeps. The SSC tool brings all the routine care questions to evaluate SUDI risk into one online tool and once entered provides a risk assessment for that individual infant expressed as rate per 1000 and 1 per xx number of infants. The SSC shows what the modifiable risks are for that infant and shows what the effect will be on the risk on their SUDI risk if the modification is made to behaviour. Midwives already have in place the ability to refer families for safe sleep devices (bassinets pepi-pod and wahakura (maaori flax woven baby bed) and written information on safe sleep is already current standard midwifery care. Midwives will request permission to forward contact details of all infants who have a SSC to the research group.
After a period of one month of use, qualitative interviewing of the midwives will be performed, to obtain feedback to refine the SSC for midwifery use.
Each use of the SSC uses contributes data to non-identifiable (encoded national health index number) data sheet maintained by the SSC researchers.
The impact of the SSC on risk will be measured by the research group by repeat measure of the SSC. This will by done by phone interview of infant caregivers 2-4 weeks after the initial Safe Sleep Calculation by the midwife.
This study is a 10 week pilot study however it is anticipated that if the SSC is useful and is effective in its current form it will then become generally available to midwives for routine care.
Intervention code [1] 293491 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296896 0
Acceptability of the SSC tool for midwife use, assessed by face-to-face interview with each participating midwife.
Timepoint [1] 296896 0
At 1 month after each midwife incorporates the SSC into their postnatal care.
Secondary outcome [1] 319956 0
Measuring change in SUDI risk by repeat SSC measurre 2-4 weeks after baseline SSC measure ( adjusting for age effect on risk).
Timepoint [1] 319956 0
2-4 weeks after baseline SSC measure.

Eligibility
Key inclusion criteria
Lead Maternity Care (LMC) midwives and Community midwives in South Auckland will
be contacted and invited to be involved in the pilot of the SSC. The study population will be mothers living in the Counties Manukau Health Board area giving birth to a full term live infant in the Counties Manukau Health Board region between December 2015 and February 2016.
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mothers and their infants will be ineligible if there is a past maternal history of SUDI, the infant
dies, remains in hospital or exceeds the study age cut off before contact has been made.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/12/2015
Date of last participant enrolment
Anticipated
26/02/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 7473 0
New Zealand
State/province [1] 7473 0

Funding & Sponsors
Funding source category [1] 292584 0
Hospital
Name [1] 292584 0
Counties Manukau District Health Board
Country [1] 292584 0
New Zealand
Primary sponsor type
Hospital
Name
Counties Manukau District Health Board
Address
Counties Manukau District Health Board,
100 Hospital Road, Papatoetoe,
Auckalnd 2025
Country
New Zealand
Secondary sponsor category [1] 291307 0
Charities/Societies/Foundations
Name [1] 291307 0
Cure Kids
Address [1] 291307 0
Cure Kids
58 Surrey Cresent
Grey Lynn,
Auckland 1021
Country [1] 291307 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294069 0
Health and Disability Ethics Committee
Ethics committee address [1] 294069 0
Ministry of Health

Freyberg Building

20 Aitken Street

PO Box 5013

Wellington

6011
Ethics committee country [1] 294069 0
New Zealand
Date submitted for ethics approval [1] 294069 0
30/11/2015
Approval date [1] 294069 0
18/12/2015
Ethics approval number [1] 294069 0
15/NTB/219

Summary
Brief summary
In New Zealand Sudden Unexpected Death (SUDI) in Infancy is the leading cause of death for infants one month to one year of age. The Counties Manukau Health Board area in South Auckland unfortunately has the highest rate of SUDI deaths in New Zealand. It is very clear, from local and international epidemiological data, that SUDI risk can be reduced by modifying the behaviours that contribute to risk.
The Safe sleep calculator (SSC) has been developed, from five large international (including the NZ Cot Death Study) case control studies, to make an accurate assessment of Sudden Unexpected Death in Infancy risk for an individual baby, and provide clear information about how caregivers can improve safety for their infants by modifying behaviours.
We intend to pilot the SSC with the South Auckland Midwives over December 2015-February 2016. Midwives will be invited to be involved in the study. They will have sign in access to the online SSC which they will be encouraged to use in routine care of mothers and infants in the postnatal period. Midwives will invite mothers/caregivers to be involved in the study and contact details of consenting mothers/caregivers will provided to the research team to enable follow up.
After a period of one month midwives will be interviewed to gather their perspectives on the acceptability and usefulness of the SSC. This information will be used to modify the SSC and to optimise it for midwifery use.
The impact of the SSC will be measured by repeated use of the SSC. The second SSC assessment will be done by the research team by telephone interview of the infants mother/caregiver 2-4 weeks after the initial SSC was performed by the midwife. Comparison will be made of modifiable behaviours over time.
This pilot is part of a wider New Zealand research programme to implement the SSC into midwifery, Well Child Providers (early childhood nurses) and General Practice. The goal is to improve the identification and awareness of SUDI risk for infants by healthcare workers and thereby produce consistency of advice around modifiable behaviours to improve infant sleep safety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 62294 0
Dr Christine McIntosh
Address 62294 0
Primary and Integrated Care,
Counties Manukau Health,
Board Office,
19 Lambie Drive,
Manukau,
Private Bag 94052,
Manukau 2241
Country 62294 0
New Zealand
Phone 62294 0
+64 2 1915220
Fax 62294 0
Email 62294 0
christine.mcintosh@middlemore.co.nz
Contact person for public queries
Name 62295 0
Dr Christine McIntosh
Address 62295 0
Primary and Integrated Care,
Counties Manukau Health,
Board Office,
19 Lambie Drive,
Manukau,
Private Bag 94052,
Manukau 2241
Country 62295 0
New Zealand
Phone 62295 0
+64 2 1915220
Fax 62295 0
Email 62295 0
christine.mcintosh@middlemore.co.nz
Contact person for scientific queries
Name 62296 0
Dr Christine McIntosh
Address 62296 0
Counties Manukau Health,
Board Office,
19 Lambie Drive,
Manukau,
Private Bag 94052,
Manukau 2241
Country 62296 0
New Zealand
Phone 62296 0
+64 2 1915220
Fax 62296 0
Email 62296 0
christine.mcintosh@middlemore.co.nz

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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