Newborn Skin Maturity Medical Device Validation for Gestational Age Prediction: Clinical Trial.

Background: Early access to antenatal care and high-cost technologies for pregnancy dating challenge early neonatal risk assessment at birth in resource-constrained settings. To overcome the absence or inaccuracy of postnatal gestational age (GA), we developed a new medical device to assess GA based on the photobiological properties of newborns' skin and predictive models.

Objective: This study aims to validate a device that uses the photobiological model of skin maturity adjusted to the clinical data to detect GA and establish its accuracy in discriminating preterm newborns.

A quantitative cross-sectional analysis of the melanin index in the skin of preterm newborns and its association with gestational age at birth.

Background: Estimation of gestational age (GA) is important to make timely decisions and provide appropriate neonatal care. Clinical maturity scales to estimate GA have used skin texture and color to assess maturity at birth facing situations of the uncertainty of pregnancy dating. The size and darkness of the areola around the nipple to grade skin characteristics are based on visual appearance.