None listed
Conditions
Brief summary
Infants are at risk of low oxygen levels and apparent life threatening events and even death whilst sleeping in infant car seats. A foam plastic insert was developed to improve the position of infants in car seats. Hypothesis: that the foam insert can prevent episodes of reduced oxygenation in infants in car seats. This study also quantified car seat use in the study group over a 6 week period.
Interventions
At 5 - 11 days age each infant was studied for one daytime sleep period (30 min to 3 hours duration) with polysomnogram recording, whilst seated in a standard car seat fitted with the foam plastic car seat insert device (fabric covered 2.5 cm thick foam 'H' shaped device with a slot cut in the top, the seat belt straps brought through the top slot and through a slim slot in the base)
Further to the sleep study the parents of infants were then asked to complete a 6 week diary of car seat use. The
At 5 - 11 days age each infant was studied for one daytime sleep period (30 min to 3 hours duration) with polysomnogram recording, whilst seated in a standard car seat fitted with the foam plastic car seat insert device (fabric covered 2.5 cm thick foam 'H' shaped device with a slot cut in the top, the seat belt straps brought through the top slot and through a slim slot in the base) Further to the sleep study the parents of infants were then asked to complete a 6 week diary of car seat use. They were required to state whether an insert was used during this time period.
Sponsors
University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Days to 11 Days
Healthy volunteers
Yes
Inclusion criteria
full term ( 37-42 weeks gestation) newborn infants healthy at time of the sleep study study performed at 5-11 days from birth.
Exclusion criteria
pre-maturity (<37 weeks gestation), any significant health concerns at recruitment
Outcome results
None listed