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Background: A handheld optical device was developed to evaluate a newborn's skin maturity by assessing the photobiological properties of the tissue and processing it with other variables to predict early neonatal prognosis related to prematurity. This study assessed the device's ability to predict respiratory distress syndrome (RDS)., Methods: To assess the device's utility we enrolled newborns at childbirth in six urban perinatal centers from two multicenter single-blinded clinical trials. All newborns had inpatient follow-up until 72 h of life. We trained supervised machine learning models with data from 780 newborns in a Brazilian trial and provided external validation with data from 305 low-birth-weight newborns from another trial that assessed Brazilian and Mozambican newborns. The index test measured skin optical reflection with an optical sensor and adjusted acquired values with clinical variables such as birth weight and prenatal corticoid exposition for lung maturity, maternal diabetes, and hypertensive disturbances. The performance of the models was evaluated using intrasample k-parts cross-validation and external validation in an independent sample., Results: Models adjusting three predictors (skin reflection, birth weight, and antenatal corticoid exposure) or five predictors had a similar performance, including or not maternal diabetes and hypertensive diseases. The best global accuracy was 89.7 (95% CI: 87.4 to 91.8, with a high sensitivity of 85.6% (80.2 to 90.0) and specificity of 91.3% (95% CI: 88.7 to 93.5). The test correctly discriminated RDS newborns in external validation, with 82.3% (95% CI: 77.5 to 86.4) accuracy. Our findings demonstrate a new way to assess a newborn's lung maturity, providing potential opportunities for earlier and more effective care., Trial Registration: RBR-3f5bm5 (online access: http://www.ensaiosclinicos.gov.br/rg/RBR-3f5bm5/), and RBR-33mjf (online access: https://ensaiosclinicos.gov.br/rg/RBR-33rnjf/)., Competing Interests: The authors declare a patent deposit on behalf of the Universidade Federal de Minas Gerais and Fundação de Amparo a Pesquisa de Minas Gerais, Brazil (http://www.fapemig.br/en/). BR1020170235688 (CTIT-PN862)., (© 2023 Reis, Pappa, Nader, do Vale, Silveira Neves, Vitral, Mussagy, Norberto Dias and Romanelli.)

Introduction: A new medical device was previously developed to estimate gestational age (GA) at birth by processing a machine learning algorithm on the light scatter signal acquired on the newborn's skin. The study aims to validate GA calculated by the new device (test), comparing the result with the best available GA in newborns with low birth weight (LBW)., Methods: We conducted a multicenter, non-randomized, and single-blinded clinical trial in three urban referral centers for perinatal care in Brazil and Mozambique. LBW newborns with a GA over 24 weeks and weighing between 500 and 2,500 g were recruited in the first 24 h of life. All pregnancies had a GA calculated by obstetric ultrasound before 24 weeks or by reliable last menstrual period (LMP). The primary endpoint was the agreement between the GA calculated by the new device (test) and the best available clinical GA, with 95% confidence limits. In addition, we assessed the accuracy of using the test in the classification of preterm and SGA. Prematurity was childbirth before 37 gestational weeks. The growth standard curve was Intergrowth-21st, with the 10th percentile being the limit for classifying SGA., Results: Among 305 evaluated newborns, 234 (76.7%) were premature, and 139 (45.6%) were SGA. The intraclass correlation coefficient between GA by the test and reference GA was 0.829 (95% CI: 0.785-0.863). However, the new device (test) underestimated the reference GA by an average of 2.8 days (95% limits of agreement: -40.6 to 31.2 days). Its use in classifying preterm or term newborns revealed an accuracy of 78.4% (95% CI: 73.3-81.6), with high sensitivity (96.2%; 95% CI: 92.8-98.2). The accuracy of classifying SGA newborns using GA calculated by the test was 62.3% (95% CI: 56.6-67.8)., Discussion: The new device (test) was able to assess GA at birth in LBW newborns, with a high agreement with the best available GA as a reference. The GA estimated by the device (test), when used to classify newborns on the first day of life, was useful in identifying premature infants but not when applied to identify SGA infants, considering current algohrithm. Nonetheless, the new device (test) has the potential to provide important information in places where the GA is unknown or inaccurate., Competing Interests: The authors declare a patent deposit on behalf of the Universidade Federal de Minas Gerais and Fundação de Amparo a Pesquisade Minas Gerais, Brazil. The inventors were ZSNR, RNG, and BR1020170235688 (CTIT-PN862). BirthTech, a spin-off company, received a license to produce and commercialize this technology, and RG is its founder. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Vitral, Romanelli, Reis, Guimarães, Dias, Mussagy, Taunde, Neves, de São José, Pantaleão, Pappa, Gaspar and de Aguiar.)