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Please use this identifier to cite or link to this item: http://hdl.handle.net/1843/55525
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dc.creatorZilma Silveira Nogueirareispt_BR
dc.creatorMarynea Silva Valept_BR
dc.creatorPaulo de Jesus Hartamann Naderpt_BR
dc.creatorMarta David Rocha de Mourapt_BR
dc.creatorRegina Amélia Pessoa Lopes de Aguiarpt_BR
dc.creatorRodney Nascimento Guimarãespt_BR
dc.creatorMaria Albertina Santiago Regopt_BR
dc.creatorRoberta Maia de Castro Romanellipt_BR
dc.creatorJuliano de Souza Gasparpt_BR
dc.creatorGabriela Luiza Nogueira Vitralpt_BR
dc.creatorMarconi Augusto Aguiar Dos Reispt_BR
dc.creatorEnrico Antônio Colósimopt_BR
dc.creatorGabriela Silveira Nevespt_BR
dc.date.accessioned2023-06-29T00:11:27Z-
dc.date.available2023-06-29T00:11:27Z-
dc.date.issued2019-01-25-
dc.citation.volume9pt_BR
dc.citation.issue3pt_BR
dc.citation.spage1pt_BR
dc.citation.epage7pt_BR
dc.identifier.doi10.1136/bmjopen-2018-027442pt_BR
dc.identifier.issn20446055pt_BR
dc.identifier.urihttp://hdl.handle.net/1843/55525-
dc.description.resumoIntroduction 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 findingspt_BR
dc.format.mimetypepdfpt_BR
dc.languageengpt_BR
dc.publisherUniversidade Federal de Minas Geraispt_BR
dc.publisher.countryBrasilpt_BR
dc.publisher.departmentICX - DEPARTAMENTO DE ESTATÍSTICApt_BR
dc.publisher.departmentMED - DEPARTAMENTO DE GINECOLOGIA OBSTETRÍCIApt_BR
dc.publisher.departmentMED - DEPARTAMENTO DE PEDIATRIApt_BR
dc.publisher.initialsUFMGpt_BR
dc.relation.ispartofBMJ Open-
dc.rightsAcesso Abertopt_BR
dc.subjectChildbirthpt_BR
dc.subjectNewbornpt_BR
dc.subjectPrematuritypt_BR
dc.subject.otherPartopt_BR
dc.subject.otherRecém nascidopt_BR
dc.subject.otherRecém-Nascido Prematuropt_BR
dc.titlePrematurity 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 devicept_BR
dc.typeArtigo de Periódicopt_BR
dc.url.externahttps://bmjopen.bmj.com/content/9/3/e027442.longpt_BR
dc.identifier.orcidhttps://orcid.org/0000-0001-5689-3870pt_BR
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