Abstract
BackgroundWeight is critical for the medical management of infants; however, scales can be unavailable or inaccessible in some practice settings. We recently developed and validated a robust infant weight estimation method based on chest circumference (CC) and head circumference (HC). This study was designed to determine the human factors (HF) experience with, and predictive performance of, an infant weight estimation device that implements this method.MethodsProspective, multi-center, observational, masked study of 486 preterm and term infants (0–90 days) assessed by 15 raters. Raters measured the infant using calibrated scales/measures and masked versions of the device. Raters also evaluated critical tasks associated with device use. Mean error (ME) and mean percentage error (MPE) were used to assess predictive performance.ResultAmong 486 infants enrolled (36.8 ± 4.0 weeks gestational age, 31.5 ± 28.6 days postnatal age), predicted weight correlated highly with actual weight (r = 0.97, ME: − 69 ± 257 g, MPE: − 1.3 ± 6.9%). Predicted weight was within 10 and 15% of actual weight in 86 and 99%, of infants. HF errors were low, 0.1–0.8% depending on task. In all cases raters were confident or very confident in their measurements.ConclusionThe device was statistically equivalent to the method on which it was based and approximated weight with acceptable variance from the true weight. HF data suggest the device is easy to use. This device can be used to estimate weight in infants when calibrated scales are impractical or unavailable.
Highlights
Weight is critical for the medical management of infants; scales can be unavailable or inaccessible in some practice settings
The data revealed that 0.6% of the 972 total babyTAPE measurements were discordant with the measurements made using the reference tape (Critical task #2)
With 86% of infants in this study predicted within 10% of actual and 99% predicted within 15% of actual, the babyTAPE is slightly more robust than the MercyTAPE evaluated using the same trial design, in which 76 and 98% of children were predicted within 10 and 20% of their actual weight, respectively [19]
Summary
Weight is critical for the medical management of infants; scales can be unavailable or inaccessible in some practice settings. We recently developed and validated a robust infant weight estimation method based on chest circumference (CC) and head circumference (HC). This study was designed to determine the human factors (HF) experience with, and predictive performance of, an infant weight estimation device that implements this method. Body weight is the foremost marker of health and health outcomes during infancy. It is essential for evaluating growth and development and is a critical factor in safe and effective medical management throughout childhood [1,2,3]. The method was based on a similar approach developed previously for weight estimation in children [11], and the resultant prototype (Mercy babyTAPE) is a variation on the U.S Food and Drug Administration cleared pediatric device (MercyTAPE). The method was based on a similar approach developed previously for weight estimation in children [11], and the resultant prototype (Mercy babyTAPE) is a variation on the U.S Food and Drug Administration cleared pediatric device (MercyTAPE). (https://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142469)
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