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Published on: February 5, 2019
The Safe-T-Sleep device: safety and efficacy in maintaining infant sleeping position
1Regional Centre for Plastic Surgery, Middlemore Hospital, Otahuhu, Auckland. dechalain@middlemore.co.nz
Insights
The Safe-T-Sleep device safely maintains infant sleeping positions, aiding in the prevention of positional plagiocephaly without increasing the risk of sudden infant death syndrome (SIDS). This study found the device effective for infant positioning.
Area of Science:
- Pediatric sleep safety
- Craniofacial development
- Infant health and wellness
Background:
- Current infant sleep recommendations prioritize supine positioning to reduce sudden infant death syndrome (SIDS) risk.
- Prolonged supine sleeping can lead to positional plagiocephaly without synostosis (PWS), a common concern for parents.
- Parents face a dilemma balancing SIDS prevention with PWS concerns.
Purpose of the Study:
- To assess the safety and efficacy of the Safe-T-Sleep device in maintaining infant sleep positions.
- To evaluate the device's potential to facilitate semi-supine positioning, thereby mitigating PWS.
- This study did not evaluate the device's efficacy in treating existing plagiocephaly.
Main Methods:
- A prospective, hospital-based trial involving 31 infants aged 0-11 months.
- 396 hours of observational data were collected on device use.
- The study focused on the device's ability to maintain selected sleeping and head positions.
Main Results:
- The Safe-T-Sleep device successfully maintained selected body positions in 94% of observations.
- Head position was maintained in 87% of observed instances.
- No significant adverse events or complications were reported during the trial.
Conclusions:
- The Safe-T-Sleep device is deemed safe and effective for maintaining infant sleep positions.
- The device is recommended as an adjunct to active counter-positioning strategies.
- It can aid in the passive correction of incipient or established positional plagiocephaly in infants.
Aims:
The issue of infant sleeping position has socio-political ramifications. Current recommendations endorse supine sleeping as an aid to reducing the risk of sudden infant death syndrome (SIDS). Persistent sleeping of a newborn infant in the same position may induce plagiocephaly without synostosis (PWS). Parents in our craniofacial clinic, whose children present with PWS, often feel torn between apparently conflicting goals--avoiding SIDS and avoiding PWS. The Safe-T-Sleep device, a form of infant sleep wrap, purportedly allows safe semi-supine positioning, thus ameliorating PWS (by preventing the infant from lying on the cranial 'flat spot') while not increasing the risk of SIDS. Before recommending the device to parents in our plagiocephaly clinics, we designed a prospective, hospital-based trial to assess the safety and efficacy of the device in maintaining selected sleeping positions. This was not a trial of the efficacy of the Safe-T-Sleep device in treating plagiocephaly.
Methods:
The devices were trialed on 31 babies, between birth and 11 months of age. A total of 396 hours of observations were recorded.
Results:
The device maintained the selected body position in 94% of recorded observations and head position in 87%. There were no significant adverse events or complications associated with the use of the Safe-T-Sleep device.
Conclusions:
The device appears to be safe and effective. It is now being advocated in our clinic as an aid to active counter-positioning strategies to passively correct incipient or established positional plagiocephaly in younger babies.
