Has this product had any professional testing or trialling?

In 1992 a professional consultative process began, which spanned nine months of trialling. The questions for our questionnaire were formulated with the help of key medical professionals and fifteen clinicians from a wide variety of fields within the medical profession including Paediatric, General Practitioners, Orthopaedic, Baby/Child Health Professionals, Plunket/Karitane family units, Hospitals, Nursing Counsellors, sleep centres, behavioural psychologists, developmental psychologists, midwives, ante and post natal tutors, clinical psychologists, occupational therapists to name a few (report available on request). The Questionnaires were sent out with official self-addressed stamped envelopes marked "questionnaire". These were opened at an official meeting at which professional people, Paediatricians and volunteers plus the parents of participants were present when they were opened and subsequently assessed. The results of the survey questionnaires provided convincing evidence that the vast majority of infants react very favourably and the vast majority of parents/caregivers were very happy with its application (raw data available). For ten years twenty five percent of despatched orders contained questionnaires which produced regular feedback. These and letters from medical professionals are available for inspection and provide overwhelming evidence that the product is meeting the comfort and safety needs of infants.

Over a period of fifteen years auditable figures show well over 200,000 babies slept safely in the original Safe T Sleep Sleepwrap product! You may be aware that SIDS education worldwide is very thorough, very clear and well distributed. Yet even with all this excellent educational advice from SIDS organisations there are still preventable deaths occurring. Also a significant percentage of infants are admitted to hospitals worldwide and being fitted with helmets to correct flat/deformed heads which is often linked to ‘back sleeping’ infants who insist on sleeping on the same spot, regardless of any attempt otherwise. Consistently since 1992 the Safe T Sleep Sleepwrap reaches up to 20% of all first time babies born each year in New Zealand alone. There have been no reported deaths or injuries! Since 1992 babies worldwide have slept more safely and comfortably in the Safe T Sleep Sleepwrap. As a result of this we believe Safe T Sleep is also helping to make a meaningful contribution to safer sleeping with the Sleepwrap and all associated evidence based information. In New Zealand, Australia and Canada Safe T Sleep has been highly commended for our responsible, professional, educational, widely consultative approach within our philosophy of positive, nurturing, trust-building and skilled parenting. For many parents and babies we have also helped prevent much of the unnecessary trauma associated with positional Plagiocephaly (flattening or deformity) of baby’s head. 

New Zealand Medical Journal vol 116 No 1181 Over recent years fully accredited Independent Hospital clinical trials have established the efficacy of the Safe T Sleep Sleepwrap product in assisting the safe positioning of sleeping babies when product instructions are followed. It has been established that the Sleepwrap is a safe and very useful adjunct to keeping an infant in a selected position. 

In February 2000, the Safe T Sleep Sleepwrap product was the only Australasian product to both exhibit and present a Paper at the International SIDS Conference held in Auckland, New Zealand. Other Papers presented have been at the 2002 International Paediatric Nurses Conference in Sydney, Australia and in the 2002 Midwifery Conference in Dunedin, New Zealand. Independent Hospital clinical trials were completed in 2002.

New Zealand Medical Journal vol 116 No 1181 Many hospitals are using Safe T Sleep Sleepwraps in the following situations: gastro-oesophageal reflux, irritable hips, cranial osteopathy, porta-catheter (central line), gastrostomies, supra-pubic catheter, traction and during some types of dressings in plastics and burn cases. Also in such areas as maintaining positions, e.g. with hypospadias patients who have to be on bed rest for a week post surgery, cleft lip and palate babies to stop them from rolling on their tummy post-operatively, and for assistance during the removal of sutures in babies and children.

The product arose due to the inventor’s experiences during her nursing training and designed the product for her own baby son who was a climber, to give her a few extra moments to get to her son after he woke before he could fall and injure himself. The statistical data available in most ‘developed’ countries indicates that nearly one in five 0-4 year olds that are hospitalised every year due to falls are from cot, bed, and bunk falls. The results are death, permanent serious brain damage and other injuries. Worldwide little education is given on this topic. See ‘testimonials’-ACC letter.

The Safe T Sleep Sleepwrap product is a 100% natural, top quality, special weave, chemical free cotton fabric ‘wrap’, which allows a baby to do everything he/she is able to do according to their age and stage of development. The only things they cannot do are those things which may put them at risk. The Safe T Sleep Sleepwrap helps ensure that a young baby, still in the high SIDS risk period, is much less likely to turn onto tummy or creep into potentially uncomfortable and/or dangerous situations whilst an older infant out of the high SIDS (cot death) risk period can be taught how to turn around within the wrap to allow them to sleep in their desired sleep position. The Safe T Sleep Sleepwrap products are also made to specific safety dimensions to ensure that babies limbs are unable to be caught or jammed. The Sleepwrap is designed and intended as a ‘wrap’ for use during sleep and for the few moments before and after sleep. The automatic fasteners will hold for those few moments from the baby waking to parent/caregiver being able to attend to the baby. For very wriggly babies see Question 12. At the manufacturing level strict compliance regulations have been met and there are three points of Quality Assurance and Quality Control procedures.

The fabric has been scientifically tested: 0.27 “Tog Rating”, which ensures the breath ability of the weave, suitability and safety for young infants, particularly important during the high SIDS (Cot Death) risk period and/or in hot climates. When the Sleepwrap is around the baby it equals 1 Tog. The product has been used successfully in Brisbane, Australia, over the past five years where temperatures can reach above 40°C. Please see letter from Amanda Stembridge.

The consistency and strength of the fabric weave and the automatic fastening strips have been hospital laundry tested for durability to ensure that the product will withstand hundreds of washes. Industrial strength cotton thread is used, all corners are mitred and backstitched and bias trim is used to ensure extra safety and durability. With all reasonable care the Safe T Sleep Sleepwrap product will safely

last for up to four years making it a very versatile and inexpensive purchase. Apart from the Safe T Sleep Sleepwrap products we are not aware of any other baby sleeptime softgood product on the market in the world which has had such extensive fabric testing and experiential track record since 1992. This includes initial Independent, Professional Market Trialling, Independent Hospital Clinical Trialling. Educational and Instructional information is based on National and International published data and extremely wide consultation with health professionals, and the direct market. For the original Safe T Sleep Sleepwrap EU and USA stringent testing requirements have been met with 100% compliance. An instruction leaflet accompanies the product to ensure wise and correct usage. The product instructions also have clear illustrations to ensure correct usage. Our website is an informative, well researched evidence-based resource for parents, carers and health professionals. An information pack for medical professionals, containing internationally published research information on PWS, Positional Asphyxia and other studies is available. We have tried to cover as much information as possible about the trialling and evidence-based material in regards to the Safe T Sleep Sleepwrap products.

We trust that some of the information below and on www.safetsleep.com will be sufficient to enable you to help facilitate generic, objective, accurate experience and education regarding the Safe T Sleep Sleepwrap products. Our information is based on published studies, national and international statistical data. We believe that we have made a reasonable contribution to reducing the significant preventable injuries and fatalities of infants due to babies standing, climbing and falling. Also those babies who creep, roll and or turn in their sleep and end up with their faces/ heads covered or jammed up hard against cot bars or bed frames, both scenarios potentially causing ‘Positional Asphyxia’ (suffocation). Ref; New Zealand Medical Journal, 26 April 2002, Vol 115, No 1152, Pages 193-4. The hard statistic of babies found with face and head covered is 25% globally therefore it is highly likely to be at least twice as high as this!

This is largely a preventable statistic by simply using the original, tested and proven Safe T Sleep Sleepwrap. The car seat was designed for comfort and safety during travel, the highchair for practical reasons during mealtimes, the pushchair for comfort and practicality whilst walking. The Safe T Sleep Sleepwrap product was designed for comfort and safety during sleep, and for the few moments before and after sleep.

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