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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

2019; BMJ; Volume: 9; Issue: 3 Linguagem: Inglês

10.1136/bmjopen-2018-027442

2044-6055

Zilma Silveira Nogueira Reis, Rodney Nascimento Guimarães, Maria Albertina Santiago Rego, Roberta Maia de Castro Romanelli, Juliano de Souza Gaspar, Gabriela Luíza Nogueira Vitral, Marconi Augusto Aguiar dos Reis, Enrico A. Colosimo, Gabriela Silveira Neves, Marynéa Silva do Vale, Paulo de Jesus H Nader, Marta David Rocha de Moura, Regina Amélia Lopes Pessoa de Aguiar,

Infant Development and Preterm Care

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.Research protocol for diagnosis, single-group, single-blinding and single-arm multicenter clinical trial with a reference standard. Alive newborns, with 24 weeks or more of pregnancy age, will be enrolled during the first 24 hours 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 72 hours of life will be associated with skin reflectance in a nested case-control study.Each local independent ethics review board approved the trial protocol. The authors intend to share the minimal anonymised dataset necessary to replicate study findings.RBR-3f5bm5.