TESTING, TRIALING & SAFETY COMPLIANCE
Safe T Sleep Sleepwrap babywrap Testing, Trialing/Safety Compliance, Product History and Medical FactsSuccessfully on the market since 1992 with no reported fatalities or injuries
Hospital Clinically trialed and proven see The New Zealand Medical Journal https://cdn.shopify.com/s/files/1/0223/2655/files/NZ_Medical_Journal_Tristan_version.pdf?1306
Scientific fabric testing see http://www.safetsleep.com/pages/testing-trialing-fabric-testing
EU and USA Requirements have been met.
US Consumer Product Safety
Complies: US code of Federal Regulations 16CFR 1303 and US Consumer Product Safety Improvement Act HR 4040
According to the US Consumer Product Safety Commission, every year, approximately 26 children die from injuries sustained in cots/cribs and more than 11,500 children require hospital treatment for preventable cot/crib-related injuries!
Safe T Sleep innovation addresses flat head concerns.
To help prevent and treat plagiocephaly without synostosis (PWS) (aka flat head), extending the options for safe positioning of sleeping infants.
This paper includes: Safe T Sleep Sleepwrap background, safety record and uses. Safe T Sleep’s uses in relation to positional Plagiocephaly without Synostosis PWS (where the skull sutures remain open), often referred to as “flat” or “misshapen” heads. The results achieved by babies with PWS referred to Safe T Sleep over the past two years. The results of an independent hospital trial completed in New Zealand. (ref. written parent feedback: http://www.safetsleep.com/blogs/testimonials/8318826-flat-heads )
Safe T Sleep® Sleepwrap® was invented by Miriam Rutherford who has a background in• nursing training • human development and training • positive parenting facilitation • community work. The mother of three children, she has been involved in campaigning for objective and full education about safer sleep for the past 25 years.
Her aim is to empower people to make wise choices by providing full, objective information about all the factors leading to safer and more restful sleeping and ultimately, peace of mind for parents.
Miriam originally developed her baby swaddle, later called the Safe T Sleep Sleepwrap, to help keep her own babies safe and settled and reduce the risk of falls and injuries. Statistics from New Zealand and Australia have highlighted that almost one in four hospital admissions for falls in the 0-2 age group are the result of falls from cots, beds and bunks.
Encouraged by many parents and health professionals including midwives and nurses, Miriam further developed her Sleepwrap babywrap which was released to the public as the Safe T Sleep Sleepwrap in 1992.
Initial trials spanned six months, involved more than 300 babies, 600 parents, 15 clinicians from different fields in the medical profession, a wide range of professionals and organisations within the community. The results were overwhelmingly positive and feedback since has showed that Safe T Sleep helps to:
- Keep babies’ faces clear during sleep.
- prevent climbing and falling during the few minutes before and after sleep.
- encourage longer more settled sleep.
- safely maintain a back or side sleeping position
- make visiting and travelling with babies easier and more practical
- reduce parental anxiety about sleep safety.
- ease the transition from cot to bed.
- provide peace of mind for caregivers and babysitters.
Safe T Sleep effectiveness has been highlighted at a number of International Medical conferences including:
- International Conference for Pediatric and Child Health Nurses: Caring for Kids.
- International Cot Death/SIDS Conference.
- International Karitane Conference.
- National Early Childhood Conference.
- International and National Midwifery Conferences.
When more than 200,000 Safe T Sleep Sleepwraps had been used without a single reported death or injury, NZ Cot Death/SIDS statistics suggested more than 100 Cot Death/SIDS deaths could have been expected in a group of this size.
Hospital Uses: At least 20 specific medical and hospital applications for the Safe T Sleep Sleepwrap baby swaddle have also been identified including positioning those with:
• breathing difficulties
• reflux conditions
• broken bones
• cleft palate
• post-operative needs.
How Safe T Sleep Works:
The Safe T Sleep Sleepwraps are recommended for babies and young children from newborn to 2years old (and sometimes older for special needs children and recreational boating use).
Parents are encouraged to use Safe T Sleep's Sleepwraps in conjunction with skilled positive parenting techniques and safe bed making practices.
A wide fabric section is secured around the mattress and is attached to a second fabric strip that wraps underneath the armpits and around the baby’s torso leaving arms and legs free to move naturally.
Dimensions are strictly specified and fabric has been scientifically tested for breathability, wash ability and strength, to ensure no risk of entanglement or “bunching” of fabric.
Portability of the Safe T Sleep Sleepwrap babywrap ensures consistent application of safe sleep practices wherever babies go.
You can adjust the Sleepwrap to suit the baby’s stage of development, size and mobility. To help maintain a sleep position see https://www.safetsleep.com/pages/frequently-asked-questions
The Safe T Sleep Sleepwraps can be used with or without rolled up towels or nappies to aid sleep positioning.
Side or back sleeping is possible, while still helping to prevent babies rolling onto their tummies, or creeping into dangerous, cold or awkward positions.
Impacts of “back to sleep”: It is well established that keeping sleeping babies off their tummies has significantly reduced the incidence of Cot Death/SIDS.
Unfortunately, supine sleeping recommendations have also been linked to reported increases in cases of Flat Heads.
A study of admissions at Middlemore Hospital indicated up to 300% more referrals for the condition over recent years and this finding is reflected internationally where “back to sleep” has been promoted.
Asymmetry more than “cosmetic”: There is a wide range of “normal” head shapes. It is the asymmetry caused by Plagiocephaly that is the concern.
Once a flat spot begins it deforms the overall head symmetry. One parent described the effect as making her child’s head look “like a book end”, in an other case a nine year old boy is teased and unable to wear a baseball cap because of the flattened back of his head, similarly a very upset medical professional referred to her daughter being unable to have plaits, ponytail or pigtails because it accentuates the unacceptable deformation of her head! Even moderate deformation can have lasting and damaging affects on a child’s self esteem, future potential and career choices.
To have BOTH a nicely shaped head and a safer sleeping baby is easily achieved with the Safe T Sleep Sleepwrap babywraps.
In some cases the condition can be linked to disfigurement including bulging foreheads, misaligned ears, flattened eye sockets and torticollis (tightened neck muscles on one side).
The “wait and see” attitude can exacerbate the problem which can be treated more easily in its earlier stages by vigilant counter-positioning.
While the softer skulls of younger babies allow problems to develop quickly, they also make corrections easier and faster to achieve.
Head turning difficult to maintain: Alternating babies’ head positions while they sleep in supine and semi-supine positions has been recommended to prevent the protracted pressure which can lead to skull deformation and does seem to work for some babies.
However, in spite of tactics such as altering head positioning, changing placement of cots and toys and increasing tummy time during the day, many babies will repeatedly revert to a preferred head position during sleep. (Repetitive pressure on any one part of the skull can cause PWS).
Active counter-positioning in babies with an established flat spot is even harder.
Premature and low birth weight infants appear to be at increased risk.
A Potentially dangerous recommendation: “Feet to foot” (Short-sheeting, making up the the bed at the bottom of the cot/crib) danger. Sole reliance on the “feet to the foot of the cot” position is not safe as some babies have died after being put to bed in this way, using their feet to lever themselves around over and across the bed and have become wedged sideways under the bedclothes. The writer met five mothers in a space of as many months, four of whom lost their babies using this method of bed making and the fifth mother (a medical professional) nearly did!
This recommendation was to be reviewed as indicated in this excerpt from a clinical review article, published in Sleep Medicine Reviews 2000.
“….in practice…most cots will often still allow the infant to turn sideways and thus for the head to become covered by bedding. ….Further studies are now indicated to resolve whether the recommendation should continue to be supported.”
However, use of a Safe T Sleep Sleepwrap babywrap helps avoid this concern.
Apart from counter-positioning recommendations, current interventions for PWS can include: Infants wearing moulded helmets or orthotic head bands at a significant cost to parents for up to 23 hours a day for several weeks or months, often resulting in irritability, pressure sores on the child’s head, disturbed, restless sleep and resultant sleep deprivation and emotional stress for parents and babies. (Just trying to keep a hat on a young child is known to be a challenge). In extreme cases, surgery (incidence of this in the United States is up to 4% 4,5)More recently, some health professionals have recommended use of a Safe T Sleep Sleepwrap (sometimes in conjunction with additional aids and techniques).
Following continued referrals over a two year period from health professionals, including craniofacial plastic surgeons, more than 40 families have used Safe T Sleep in conjunction with practical wrapping and positioning techniques and advice to assist their baby’s corrective head positioning. All have achieved significant improvements in their baby’s head shape. Among them were two young patients who were scheduled for surgical intervention but have now had their head shapes completely resolved. Many affected parents now express the view that their baby’s problem could have been prevented. (Ref. written parent feedback).
Independent Hospital Clinical Trial. Following Safe T Sleep’s success in the community a formal hospital trial was set up by Canadian/New Zealand craniofacial plastic surgeon based at Auckland’s Middlemore Hospital. Dr Tristan de Chalain received Ethical Approval and tested “whether varied head/body positions can be achieved safely and effectively in neonates and older babies using a Safe T Sleep Sleepwrap babywrap according to the instructions.”
• Babies were categorised into age intervals of 0-3 months, 3-6 months, 6-9 months or 9-12 months
• they were put to bed in semi-supine positions using a Safe T Sleep Sleepwrap
• the lower arm was placed forward and the head turned to the left or the right.
• head and body positions were observed and recorded every hour, as were variances from the positions selected.
A total of 31 babies were involved and nearly 400 hours of observation was recorded.
Across all age groups:
• efforts to maintain body position were at least 90% successful (with a mean of 94%). • efforts to maintain head position were at least 80% successful (with a mean of 86.5%).
Successful Maintenance of Body positioning
Safe T Sleep Trial Results Mean Percentages
There were few adverse events involving unwanted head/body movement.
Limitations of data – the 3-6 month and 9-12 month groups were small.
The overall results are significant.
Dr Chalain concluded that it is in helping families to achieve the goal of semi-supine sleeping with alternate head positions that the Sleepwrap® is most useful, especially as a training aid with the younger babies, or as a behavior modifier in the slightly older baby.
In 2002 Safe T Sleep Sleepwraps had been tried, tested and proven in the community for 10 years with overwhelming success. At this time well over than 60,000 have been used without a single reported death or injury.More than 40 families have successfully corrected PWS using the Safe T Sleep Sleepwrap babywrap swaddles. The Independent Hospital trials have demonstrated that they are a safe and effective tool in achieving and maintaining varied body and head positions without increasing the risk of Cot Death/SIDS. Prevention is better than cure. With full and objective information, well informed health professionals and the right tools, parents and caregivers can reduce the likelihood of Flat Head/PWS developing. You don’t have to choose between reducing the risk of Cot Death/SIDS and misshapen heads. Both issues can be successfully addressed at the same time.
Otago Injury Prevention Unit study of New Zealand hospital admissions of infants 0-2 years. 1989. (1996 1.9 SIDS deaths per 1000 live births; 1997 1.4 SIDS deaths per 1000 live births and higher SIDS incidence prior to that). Mitchell EA, Brunt JM, Everard C. Reduction in mortality from sudden infant death syndrome in New Zealand: 1986-92. Arch Dis Child 1994: 70:291-294.Argentina et.al An increase in Infant Cranial Deformity with Supine Sleeping Position published in the Journal of Craniofacial Surgery Jan. 1996.Turk A.E. et al. The “Back to Sleep” Campaign and deformational Plagiocephaly: Is there cause for concern? The journal of Craniofacial Surgery Vol. 7. No.1 12-18 Jan. 1996. Littlefield TR et al. Multiple Birth Infants at Higher Risk for Deformational Plagiocephaly. Paediatric Vol 103:3 March 1999 565-9.Gunn AJ, Gunn TR, Mitchell EA is changing the sleep environment enough? Current recommendations for SIDS, Sleep Medicine Reviews Vol.4, No.5, 2000 453-469.
• Free bassinet sized Safe T Sleep for educational/demonstration purposes
• Free bassinet sized Safe T Sleep for midwifery centre display purposes
• Safe T Sleep brochures
• Safe T Sleep instructions (in five languages)
• Copies of reference papers (Medical Info Pack)
• Copies of parent testimonials
• Advice on grants available to low income households requiring Safe T Sleep Sleepwrap
• Advice on special sheet folding and baby wrapping techniques in order to assist in correcting Flat Head/PWS
• Specially designed HEADwedges to be used in conjunction with the Safe T Sleep Sleepwrap
International SIDS Conference
Safe T Sleep® Sleepwrap® may reduce the incidence of Cot Death/SIDS
It is well established that prone sleep position increases the risk of SIDS and SIDS mortality has decreased dramatically since the recommendation that infants are not placed prone to sleep. However, SIDS mortality in New Zealand continues to be high (1996:1/9/1000 live births).
Side sleeping position is also associated with a two fold increased risk of SIDS compared with the back sleeping position (1), probably due to infants turning on their fronts (secondary prone). If an infant is placed on their side it is recommended that the lower arm and shoulder are placed well forward to reduce the chance of the infant turning prone. But even if the infant is placed on the back to sleep he may still turn to the prone position (2).
The recommendation to sleep healthy infants only in a supine position has reportedly been linked to increasing rate of Plagiocephaly.
Safe T Sleep® Sleepwrap® babywrap
The Safe T Sleep Sleepwraps were designed by a mother with a nursing background to help provide comfort and security during sleep for her own babies by helping to prevent babies “creeping” into dangerous or potentially suffocating positions prevent the dangers of climbing and falling during the few minutes before and after sleep reduce parental anxiety about sleep safety.
Subsequently the danger of sleeping babies in a prone position became recognised as a significant risk factor in Cot Death/SIDS and the Safe T Sleep Sleepwrap’s ability to ensure either supine or lateral sleeping positions, while eliminating the risk of babies turning to a secondary prone position, was realised as a major advantage of the product. The option of a stable side sleeping position has also been useful in addressing concerns about increased occurrence of Plagiocephaly among some infants who sleep only in a supine position.
The Safe T Sleep babywraps includes a wide fabric section that secures around the mattress and a second broad fabric strip that wraps underneath the armpits and around the baby’s torso, leaving arms and legs free. Dimensions and fabric strength are strictly specified to ensure no risk of entanglement or “bunching” of fabric to from a cord. An occupational therapist assessed the Sleepwrap and judged that it “allowed natural movement during sleep and does not restrict the child’s limbs while simultaneously keeping the child in a comfortable supine position.” It is recommended that the Sleepwrap be used strictly according to its instructions and in conjunction with safe, responsible bedding practices including large “tuck under” sheets and blankets.
The Safe T Sleep babywrap swaddles are recommended for babies and young children between birth and 2years old (and sometimes older for special needs children). Safe T Sleep Sleepwrap has been used to control sleep positions in a number of medical and surgical situations including caring for premature babies and helping to position apnoea monitors; post-operative positioning for some operations; protecting colostomy bags or porta catheters; positioning of patients with broken limbs, burns, gastro-oesophageal reflux, hiatus hernia, cleft lip and palate, and cranial osteopathy. Application of the Sleepwrap can be adjusted to suit increasing independence of the child as age and mobility increases. Portability of the Safe T Sleep Sleepwrap babywrap ensure consistent application of safer sleeping practices even in unfamiliar environments.
To date hundreds and thousands of Safe T Sleep Sleepwrap babywraps have been used throughout the world without a single reported death or injury. This result is significant given that national statistics suggest that 91 Cot Death/SIDS deaths could have been expected in a group this size. Even if the Safe T Sleep Sleepwrap baby swaddles are used mainly by families at lower risk of Cot Death/SIDS (such as non-Maori and socio-economically advantaged families) this result is still outstanding.
Feedback from users indicates a general trend toward more settled, longer sleeping patterns among infants and a dramatic reduction in the number of infants found in awkward or dangerous positions on waking. Parental anxiety is greatly reduced and portability of the Sleepwrap babywrap ensures more consistent application of safer sleeping practices.
Limitations of data: While reporting systems are informal, including random surveys sent out with the product, direct feedback from parents, caregivers and health professionals and regular interaction with key user groups through conferences and expos, it is reasonable to suppose that it would be likely that the extreme outcome of death would be notified through direct or indirect channels.
- 2. A side sleep position may be safe if the infants were unable to roll to the front.3. The option of safe side sleeping may be of value in avoiding and/or treatment of Plagiocephaly.4. Safe T Sleep Sleepwrap should be formally evaluated to confirm these observations.
- 2. Mitchell EA, Thach BT, Thompson JMD, Williams SM. Changing infants’ sleep position increases risk of sudden infant death syndrome. Arch Pediatric Adolescent Med 1999; 153: 1136-1441.
Miriam Rutherford-van Gisbergen
Safe T Sleep (NZ) Limited