Premature or Small for Gestational Age Discrimination: International Multicenter Trial Protocol for Classification of the Low-Birth-Weight Newborn Through the Optical Properties of the Skin

作者：Zilma Silveira Nogueira Reis, Gabriela Luíza Nogueira Vitral, Rodney Nascimento Guimarães, Juliano de Souza Gaspar, Enrico A. Colosimo, Sérgio Taunde, Nilza Mussagy, Rita Rosado Santos, Diogo Ayres‐de‐Campos, Roberta Maia de Castro Romanelli · 发表于：JMIR Research Protocols · 年份：2020 · DOI：10.2196/16477 · 被引用次数：9 · 研究领域：Neonatal skin health care、Preterm Birth and Chorioamnionitis、Neonatal Respiratory Health Research

BACKGROUND: A low birth weight is an independent risk factor for adverse infant outcomes and a predictor of chronic disease in adulthood. In these situations, differentiating between prematurity and small for gestational age (SGA) or simultaneous conditions is essential to ensuring adequate care. Such diagnoses, however, depend on reliable pregnancy dating, which can be challenging in developing countries. A new medical optoelectronic device was developed to estimate gestational age (GA) at birth based on newborn skin reflection. OBJECTIVE: This study will aim to evaluate the device's ability to detect prematurity or SGA, or both conditions simultaneously as well as predict short-term pulmonary complications in a cohort of low-birth-weight newborns. METHODS: This study protocol was designed for a multicenter cohort including referral hospitals in Brazil and Mozambique. Newborns weighing 500-2500 g will be eligible for inclusion with the best GA available, considering the limited resources of low-income countries. Comparator-GA is based on reliable last menstrual period dating or ultrasound assessment before 24 weeks' gestation. Estimated GA at birth (Test-GA) will be calculated by applying a novel optoelectronic device to the newborn's skin over the sole. The average difference between Test-GA and Comparator-GA will be analyzed, as will the percentage of newborns who are correctly diagnosed as preterm or SGA. In addition, in a nested case-control study, the accuracy of skin r...