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| Journal of the New Zealand Medical Association,
12-September-2003, Vol 116 No 1181
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The Safe-T-Sleep®
device: safety and efficacy in maintaining infant sleeping position
Tristan de Chalain
New Zealand has experienced something of an epidemic of
sudden infant death syndrome (SIDS) or cot deaths over recent years. As a
result, there has been considerable national debate about the issue and research
into causal factors is examined with great interest by a wide range of
interested parties. Current recommendations from experts in the field strongly
advocate supine positioning for sleeping infants, citing a sixfold reduction in
the risk of SIDS when compared with a prone sleeping position, and a threefold
reduction when compared with
side-lying.1,2,3
Concomitant with the reduction in SIDS rates that these
recommendations have produced, is a marked increase in the number of babies in
New Zealand referred for advice regarding plagiocephaly without synostosis (PWS)
or ‘flat heads’.4 It is axiomatic
that if a neonate, and more especially a premature neonate, is positioned
consistently in the same attitude, be it supine, supine with the head turned to
one side, or side-lying, the cranium will flatten, simply due to the effects of
gravity pressing a soft skull against a relatively unyielding surface (the
mattress). A comparable rise in the numbers of PWS referrals has been seen in
the USA in the years subsequent to the 1992 recommendation from the American
Academy of Paediatrics that supine sleeping was best for
babies.5,6 It is hard to escape the conclusion
that supine sleeping, with a single, maintained attitude, may be causally
related to flat-head presentations.
Since most cases of PWS can be prevented, or, if picked up
early, resolved by active counter-positioning (ie, never allowing the infant to
sleep on the cranial ‘flat spot’), it would be useful to be able to
offer parents some practical means of applying the principle that the child must
not be allowed to sleep on the flattened plane of a deformed skull. That is,
some way of being able to select and maintain a sleeping position that is both
safe and effective. Too often children of six months or older are referred for
consultation regarding a well-established case of PWS; the trouble is that, by
this time, not only is the deformity well developed and obvious, but the child
is also old enough to have very firm ideas about what is his or her favoured
sleeping position and will actively resist parental attempts to modify this. It
is much more comfortable for the baby to lie with the flat spot down on the
mattress than try to sleep balancing the skull on the adjacent high spot. It is
precisely because of this difficulty that some resort to orthotic devices such
as the DOC band® and cranial moulding
helmets.5 Not only are such devices costly and
difficult to make, but they need regular adjustment to remain effective as the
head shape alters. In many cases they are simply abandoned by parents frustrated
by the difficulties of finding a comfortable, efficacious, device that the
infant will tolerate wearing. Certainly, PWS is easier to prevent than resolve;
while most children, given sufficient time and attention to restricting pressure
on the flat spot, will revert towards normal craniofacial symmetry, some are
left with significant asymmetry, which even exuberant hair growth cannot fully
hide. In the USA, long-term follow-up studies have shown that about 4% of cases
remain sufficiently deformed to warrant consideration for surgical correction of
the plagiocephaly.7
Consequently, when the commercially available
Safe-T-Sleep® (STS) device came to our
attention, it was felt that it might offer a means whereby an infant, presenting
with incipient or established PWS, might safely sleep in the semi-supine
position, but with the head turned away from the flat spot and mattress pressure
confined to the high-spot area. In other words, it might offer a means of
maintaining control of sleeping position and therefore be useful as an adjunct
in the treatment of the burgeoning number of babies presenting with flat heads.
Before recommending the device to parents, however, we needed to be certain that
it was both safe and effective in maintaining sleeping position. To this end, a
prospective, hospital-based trial was designed to assess the STS device. It
should be noted that this was not a
trial of the device’s efficacy in the treatment of established PWS or
‘flat head’, since we have already established that active
counter-positioning (ie, prevention of the infant lying on the flat spot), by
whatever means achieved, is very effective at correcting
plagiocephaly.4 If it could be shown that the
STS device was both safe and effective at maintaining a selected sleeping
position, we would be able to recommend it to parents of plagiocephalic infants
as a useful adjunct in achieving active counter-positioning.
MethodsA prospective trial was
designed in which a number of STS devices were purchased and trialled, according
to the manufacturer’s instructions, in the wards and special care units of
Middlemore Hospital, a large, regional healthcare facility located in suburban
South Auckland. The manufacturers of the device had no input into the design of
the study or its outcome, and no financial or material benefit accrues to the
hospital or the authors as a result of this study. Those involved in the design
and execution of the study have no connection whatsoever with the manufacturers
of the STS device.
After obtaining ethical approval to proceed with the
study, and obtaining informed consent from individual parents or caregivers of
each baby entered in the trial, the following design was applied.
All trial entrants were categorised according to age
interval: 0–3 months, 3–6 months, 6–9 months and 9–12
months. Babies were eligible for entry into the trial providing they were not
afflicted with PWS and they were spending at least one night in the hospital in
the medical or surgical wards. Neonates in the special care baby unit (SCBU) for
observation or treatment of a relatively minor complaint, which did not impact
significantly on their overall mobility or strength, were also eligible. The
primary care physician in charge of each patient, who was not part of the study
team, assessed their patient as being suitable for trial entry and parents
reserved the right to remove their baby from the trial at any time.
Each entrant was placed in an STS device when being put
down for a night’s sleep and the selected head and body position noted.
(See appendix for demonstration of how STS device is fitted.) The starting
position was semi-supine or supine, with the head turned to the left or to the
right. The immediate care-giving nurse had freedom to select the initial
sleeping position, according to the infant’s perceived needs. When
semi-supine was chosen as the start position, a rolled towel was placed behind
the raised shoulder. Every hour thereafter, the observed head and body positions
were noted and recorded. Variances from the positions selected were documented,
as were difficulties like restlessness, ‘escape’ from the device,
and possible dangerous positioning, such as facial obstruction by bedclothes,
soft toys and so on. The data were recorded by night-staff nurses at the
bedside, who were otherwise not involved in the study. Data were recorded as
hours’ observation points, and form the basis of the analyses that
follow.
ResultsTable 1. Hours of observation of infants wearing STS
devices
Table 2. Proportional maintenance of selected sleeping
position
*numbers in brackets indicate ratio of hours of
observation in which position not maintained
Table 3. Adverse events summary
*In no instance was a child actually able to turn into
the prone position. However, failure to apply the STS sleep wrap according to
the manufacturer’s instructions makes this a theoretical risk.
DiscussionIn assessing the results of this
simple data-collection exercise, several useful points can be made.
In the first instance, it would appear that the younger the
baby the easier it is to select and maintain a sleeping position with the STS
device. This is probably true of any similar behaviour the parents may be trying
to teach the child and probably relates to tolerance; in the neonatal period,
novelty is more readily accepted. As the babies become older, they become
stronger, louder and less likely to passively accept such impositions as a
relatively restrictive positioning device.
Overall, there were very few untoward experiences with the
STS device. In no single instance was a child ever at physical risk. However, in
two babies in the 0–3 month age group the device was applied too loosely.
This allowed a deal of unwanted movement that could conceivably have resulted in
an unmonitored child being able to turn over within the device sufficiently to
place itself at risk. However, when the device was firmly applied and pinned to
the overpants, as recommended by the manufacturer, this did not occur.
Not surprisingly, the babies’ heads were free to move
more than were their bodies. Nevertheless, for this sample of 31 babies
undergoing nearly 400 hours of monitored observation, the STS device was at
least 85% (mean 87%) successful in maintaining selected head position, and at
least 92% (mean 94%) successful in maintaining body position, across all age
groups.
Although the major flaw of very low patient numbers in some
of the groups precludes extrapolation to the wider population, it nevertheless
appears that the STS device may well be helpful to those wishing to maintain a
selected sleeping position in babies. As such it might prove a useful addition
to a therapeutic programme of active counter-positioning as treatment for
cranial moulding or plagiocephaly. Not surprisingly, it is most readily accepted
when introduced early in the baby’s life; indeed, its use in the treatment
of positional plagiocephaly may be obviated by the early introduction of
intelligent advice regarding sleeping position. We tell our families to practise
supine sleeping with the head turned to the left on night one, to the right on
night two and so on. It is in helping such families to achieve this goal,
especially as a training aid in the younger babies, or as a behaviour modifier
in the slightly older baby, that such a device would seem to be most useful. Its
efficacy in specifically altering the plagiocephalic deformation that is being
seen much more commonly today remains to be established (although, anecdotally,
it would indeed seem to be very effective in this regard). At the least,
however, our data have enabled us to recommend the device to our patients’
families as being effective and safe in maintaining a selected sleeping position
in babies less than a year of age.
Author information:
Tristan de Chalain, Consultant Surgeon, Paediatric Plastic Surgery, Cleft and
Craniofacial Surgery Service, Regional Centre for Plastic Surgery, Middlemore
Hospital, Auckland
Correspondence: Dr
Tristan de Chalain, Regional Centre for Plastic Surgery, Middlemore Hospital,
Private Bag 93311, Otahuhu, Auckland. Fax: (09) 276 0004; email: dechalain@middlemore.co.nz
References:
Appendix
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