Newborn skin reflection: Proof of concept for a new approach for predicting gestational age at birth. A cross-sectional study

Reis, Zilma Silveira Nogueira; Vitral, Gabriela Luiza Nogueira; Souza, Ingrid Michelle Fonseca de; Rego, Maria Albertina Santiago; Guimarães, R.

doi:10.48550/arxiv.1709.07985

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“…In the development phase of the device, the relationships between the maturation of the newborn's skin and the optical properties were studied and it is believed that, as the GA advances, the thickening of the layers of the epidermis and dermis leads to greater light reflection ( 21 , 31 , 32 ). It has been observed that this relationship is directly proportional until approximately 35 weeks of gestation ( 21 ), a moment that coincides with the complete development of the epidermis ( 33 ). Therefore, it is possible that the test performs better in estimating GA in preterm newborns than in term newborns.…”

Section: Discussionmentioning

confidence: 99%

“…During the proof of concept step of development ( 21 ), the sole was the site of the newborn body with a higher linear coefficient between the skin reflection and GA than others, with the advantage of attending the patient security recommendation for minimum manipulation of newborns. Furthermore, concerning the intervenient effect of humidity, environment temperature and light, and newborn incubator staying, they were removed with enhanced sensor design, achieving a prediction model without environmental variable adjustments ( 22 ).…”

Section: Methodsmentioning

confidence: 99%

“…By mitigating shortcomings in the quality of healthcare services ( 19 ), innovative solutions have the potential to save lives ( 20 ). In light of this, a new, affordable healthcare device has been developed that estimates GA with an artificial intelligence-based prediction model that uses the photobiological properties of the newborn's skin in combination with clinical variables ( 21 ). Assessing 781 newborns any weight, the discrimination between preterm and term newborns via the device had a similar area under the receiver operating characteristic curve (0.970, 95% CI: 0.959–0.981) compared with that for LMP- gestational age (0.957, 95% CI: 0.941–0.974) ( 22 ).…”

Section: Introductionmentioning

confidence: 99%

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Gestational age assessed by optical skin reflection in low-birth-weight newborns: Applications in classification at birth

et al. 2023

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IntroductionA 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).MethodsWe 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.ResultsAmong 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).DiscussionThe 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.

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