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

ABSTRACT:

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.

Methods

A multicenter, single-blinded, and single-arm intention-to-diagnosis clinical trial evaluated the accuracy of a novel device for the detection of GA and preterm newborns. The first-trimeste

SUBMITTER: Reis ZSN 

PROVIDER: S-EPMC9494223 | biostudies-literature | 2022 Sep

REPOSITORIES: biostudies-literature