Protocol Deviation in Ensuring Accurate Weight Assessment in Newborns and Young Infants (babyTAPE)

Protocol Deviation data
Study Description
TAP02 objectives were to obtain anthropometric data to allow modification of the Mercy Method and Mercy TAPE to develop the babyTAPE for weight estimation in newborns and young infants. A total of 2097 infants were enrolled at eight sites, stratified to include a cross-section of newborn ages and sizes including preterm. Singular length and girth surrogates correlating most closely with weight were identified and a mathematical model for weight estimation in this population was developed and internally validated. Head circumference and chest circumference demonstrated the best correlations with weight and length and were among the most reproducible as reflected by intraclass correlation coefficients. The final model predicted weight within 10% and 15% of actual for 84% and 94% of infants, respectively, without bias for age measures or sex. No adverse device events were reported. The TAP02 study enrolled a total of 2097 infants, between 0 to 90 days of age at enrollment and stratified by postnatal and gestational age at birth.