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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

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dc.contributor.authorReis, Zilma
dc.contributor.authorVitral, Gabriela
dc.contributor.authorGuimarães, Rodney
dc.contributor.authorGaspar, Juliano
dc.contributor.authorColosimo, Enrico
dc.contributor.authorTaunde, Sergio
dc.contributor.authorMussagy, Nilza
dc.contributor.authorSantos, Rita Rosado
dc.contributor.authorAyres-de-Campos, Diogo
dc.contributor.authorRomanelli, Roberta
dc.date.accessioned2022-06-06T13:37:18Z
dc.date.available2022-06-06T13:37:18Z
dc.date.issued2020
dc.description© Zilma Reis, Gabriela Vitral, Rodney Guimarães, Juliano Gaspar, Enrico Colosimo, Sergio Taunde, Nilza Mussagy, Rita Rosado Santos, Diogo Ayres-De-Campos, Roberta Romanelli. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 14.07.2020. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.pt_PT
dc.description.abstractBackground: 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 reflection in the prediction of prematurity-related respiratory problems will be evaluated. The estimated required sample size is 298 newborns. Results: Teams of health professionals were trained, and standard operating procedures were developed following the good practice guidelines for the clinical investigation of medical devices for human participants. The first recruitment started in March 2019 in Brazil. Data collection is planned to end in December 2020, and the results should be available in March 2021. Conclusions: The results of this clinical study have the potential to validate a new device to easily assess postnatal GA, supporting SGA identification when pregnancy dating is unreliable or unknown.pt_PT
dc.description.sponsorshipThis research was supported by a Grand Challenges Exploration grant from the Bill & Melinda Gates Foundation (Grant No. OPP1128907, Contract; http://www.gatesfoundation.org/) and the Fundação de Amparo a Pesquisa de Minas Gerais, Brazil (Grant Nos AUC-00032-15 and PPM 0247/16; http://www.fapemig.br/en/; nonprofit sector). This study is funded by Fundação Oswaldo Cruz – Rio de Janeiro, Brazil, Grand Challenges Canada’s programs, Government of Canada – Toronto, Canada (Grant No. R-ST-POC-1807-13515).pt_PT
dc.description.versioninfo:eu-repo/semantics/publishedVersionpt_PT
dc.identifier.citationJMIR Res Protoc. 2020 Jul 14;9(7):e16477pt_PT
dc.identifier.doi10.2196/16477pt_PT
dc.identifier.eissn1929-0748
dc.identifier.urihttp://hdl.handle.net/10451/53277
dc.language.isoengpt_PT
dc.peerreviewedyespt_PT
dc.publisherJMIR Publicationspt_PT
dc.relation.publisherversionhttps://www.researchprotocols.org/pt_PT
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/pt_PT
dc.subjectChildbirthpt_PT
dc.subjectEquipment and suppliespt_PT
dc.subjectFetal growth restrictionpt_PT
dc.subjectPhotomedicinept_PT
dc.subjectPrematuritypt_PT
dc.subjectSkin physiological phenomena.pt_PT
dc.titlePremature or small for gestational age discrimination: international multicenter trial protocol for classification of the low-birth-weight newborn through the optical properties of the skinpt_PT
dc.typejournal article
dspace.entity.typePublication
oaire.citation.issue7pt_PT
oaire.citation.titleJMIR Research Protocolspt_PT
oaire.citation.volume9pt_PT
person.familyNameRosado Santos
person.familyNameAyres-de-Campos
person.givenNameRita
person.givenNameDiogo
person.identifier.ciencia-id4414-0F40-DCFE
person.identifier.orcid0000-0002-9299-3366
person.identifier.orcid0000-0002-7136-6240
person.identifier.ridH-9131-2013
person.identifier.scopus-author-id6603806720
rcaap.rightsopenAccesspt_PT
rcaap.typearticlept_PT
relation.isAuthorOfPublication1b3ddefa-a369-46da-92fb-1d44f19992b8
relation.isAuthorOfPublication108dde37-683c-4dc3-b963-98afdcd0d8cd
relation.isAuthorOfPublication.latestForDiscovery108dde37-683c-4dc3-b963-98afdcd0d8cd

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