The Safe-T-Sleep device: safety and efficacy in maintaining infant sleeping position.

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.