The effects of clothing layers on the thermoregulatory responses to short duration babywearing in babies under 12 months old.

Carrying babies in a sling, that is, babywearing, is a popular practice among new parents. Babies are thermally vulnerable and public health bodies advise to dress them in one extra layer than the adult. However, these guidelines do not consider babywearing and it is unclear whether babies' clothing insulation should be modified during babywearing. Here we quantified the effects of babies' clothing layers on the thermoregulatory responses to short duration babywearing in babies under 12 months old. Nine babies (4F/5M; 7.3 ± 3.1 months; 9 ± 2.5 kg) and 9 mothers (34 ± 3.0 years) performed two trials in a thermoneutral environment (23°C; 50%RH). During trials, babies wore either 1 (sleepsuit) or 2 (vest + sleepsuit) clothing layers, and mothers performed 15-min stepping exercise while babywearing. We recorded mothers and babies' tympanic temperature (Tty ), babies' local skin temperatures (Tsk ; on the carotid artery area, arm, abdomen, lower back, and thigh), and mothers' perception of babies' thermal state. Babies' Tty did not change after 15-min babywearing (mean change: -0.13°C [-0.30, +0.05]; p = .141), in either clothing trial (difference between trials: +0.05°C [-0.15, +0.25]; p = .591). On the contrary, local Tskin increased across all sites tested (mean increase = +0.71°C [+0.41, +1.01]; p = .038) and similarly between clothing trials, with the abdomen showing the largest change (+1.10°C [+0.32, +1.85]). Mothers did not perceive any change in babies' thermal state. We show that 15-min babywearing increase babies' skin, but not tympanic, temperature by up to 1.1°C on certain body regions, and that this effect is not exacerbated by adding 1 layer of light clothing to the baby.

In vitro and in vivo safety evaluation of Nephure™.

Nephure™ is a proprietary oxalate decarboxylase (OxDC) enzyme being developed as a food ingredient. In this study, the safety of Nephure™ was evaluated in a bacterial mutagenicity assay and in a sub-chronic (13-week) oral toxicity study in rats. Nephure™ did not show any mutagenic properties in the mutagenicity assay. In the 13-week sub-chronic oral toxicity study in which 10 Sprague Dawley rats per sex were administered 0, 118, 235 and 475 mg/kg bw/day (8260, 16450 and 33,250 Units/kg bw/day, respectively) of Nephure™ by gavage, male and female rats did not show any test article-related clinical observations or effects on body weight, body weight gain, food consumption, food efficiency, ophthalmology, functional observational battery parameters or motor activity. Furthermore, there were no changes in coagulation, clinical chemistry, urinalysis or hematology parameters, macroscopic/microscopic findings or organ weights that could be attributed to the test article. Based on these results, Nephure™ was not mutagenic and the no-adverse-effect level (NOAEL) in the 13-week study was determined to be 475 mg/kg bw/day (33,250 Units/kg bw/day). Evaluation of the estimated consumption of Nephure™, generation of the metabolite formate, and the current safety studies resulted in a conclusion of a tolerable upper limit of 3450 Units of OxDC activity/day (57.5 Units activity/kg bw/day), when Nephure™ is added to food to decrease dietary oxalate.