Prematurity detection evaluating interaction between the skin of the newborn and light: protocol for the preemie-test multicentre clinical trial in brazilian hospitals to validate a new medical device

• Autor(a) principal: Zilma Silveira Nogueirareis
• Data de Publicação: 2019
• Outros Autores: Marynea Silva Vale, Paulo de Jesus Hartamann Nader, Marta David Rocha de Moura, Regina Amélia Pessoa Lopes de Aguiar, Rodney Nascimento Guimarães, Maria Albertina Santiago Rego, Roberta Maia de Castro Romanelli, Juliano de Souza Gaspar, Gabriela Luiza Nogueira Vitral, Marconi Augusto Aguiar Dos Reis, Enrico Antônio Colósimo, Gabriela Silveira Neves
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Repositório Institucional da UFMG
• Texto Completo: http://hdl.handle.net/1843/55525; https://orcid.org/0000-0001-5689-3870
• topic: Childbirth; Newborn; Prematurity; Parto; Recém nascido; Recém-Nascido Prematuro

Introduction Recognising prematurity is critical in order to attend to immediate needs in childbirth settings, guiding the extent of medical care provided for newborns. A new medical device has been developed to carry out the preemie-test, an innovative approach to estimate gestational age (GA), based on the photobiological properties of the newborn's skin. First, this study will validate the preemie-test for GA estimation at birth and its accuracy to detect prematurity. Second, the study intends to associate the infant’s skin reflectance with lung maturity, as well as evaluate safety, precision and usability of a new medical device to offer a suitable product for health professionals during childbirth and in neonatal care settings.Methods and analysis Research protocol for diagnosis, singlegroup, singleblinding and singlearm multicenter clinical trial with a reference standard. Alive newborns, with 24 weeks or more of pregnancy age, will be enrolled during the first 24hours of life. Sample size is 787 subjects. The primary outcome is the difference between the GA calculated by the photobiological neonatal skin assessment methodology and the GA calculated by the comparator antenatal ultrasound or reliable last menstrual period (LMP). Immediate complications caused by pulmonary immaturity during the first 72hours of life will be associated with skin reflectance in a nested case–control study.Ethics and dissemination Each local independent ethics review board approved the trial protocol. The authors intend to share the minimal anonymised dataset necessary to replicate study findings