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

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dc.creatorZilma Silveira Nogueirareis
dc.creatorMarynea Silva Vale
dc.creatorPaulo de Jesus Hartamann Nader
dc.creatorMarta David Rocha de Moura
dc.creatorRegina Amélia Pessoa Lopes de Aguiar
dc.creatorRodney Nascimento Guimarães
dc.creatorMaria Albertina Santiago Rego
dc.creatorRoberta Maia de Castro Romanelli
dc.creatorJuliano de Souza Gaspar
dc.creatorGabriela Luiza Nogueira Vitral
dc.creatorMarconi Augusto Aguiar Dos Reis
dc.creatorEnrico Antônio Colósimo
dc.creatorGabriela Silveira Neves
dc.date.accessioned2023-06-29T00:11:27Z
dc.date.accessioned2025-09-09T01:19:35Z
dc.date.available2023-06-29T00:11:27Z
dc.date.issued2019-01-25
dc.format.mimetypepdf
dc.identifier.doi10.1136/bmjopen-2018-027442
dc.identifier.issn20446055
dc.identifier.urihttps://hdl.handle.net/1843/55525
dc.languageeng
dc.publisherUniversidade Federal de Minas Gerais
dc.relation.ispartofBMJ Open
dc.rightsAcesso Aberto
dc.subjectParto
dc.subjectRecém nascido
dc.subjectRecém-Nascido Prematuro
dc.subject.otherChildbirth
dc.subject.otherNewborn
dc.subject.otherPrematurity
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 device
dc.typeArtigo de periódico
local.citation.epage7
local.citation.issue3
local.citation.spage1
local.citation.volume9
local.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 findings
local.identifier.orcidhttps://orcid.org/0000-0001-5689-3870
local.publisher.countryBrasil
local.publisher.departmentICX - DEPARTAMENTO DE ESTATÍSTICA
local.publisher.departmentMED - DEPARTAMENTO DE GINECOLOGIA OBSTETRÍCIA
local.publisher.departmentMED - DEPARTAMENTO DE PEDIATRIA
local.publisher.initialsUFMG
local.url.externahttps://bmjopen.bmj.com/content/9/3/e027442.long

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