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

Detalhes bibliográficos
Autor(a) principal: Reis, Zilma
Data de Publicação: 2020
Outros Autores: Vitral, Gabriela, Guimarães, Rodney, Gaspar, Juliano, Colosimo, Enrico, Taunde, Sergio, Mussagy, Nilza, Santos, Rita Rosado, Ayres-de-Campos, Diogo, Romanelli, Roberta
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
Texto Completo: http://hdl.handle.net/10451/53277
Resumo: © 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.
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spelling 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 skinChildbirthEquipment and suppliesFetal growth restrictionPhotomedicinePrematuritySkin physiological phenomena.© 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.Background: 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.This 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).JMIR PublicationsRepositório da Universidade de LisboaReis, ZilmaVitral, GabrielaGuimarães, RodneyGaspar, JulianoColosimo, EnricoTaunde, SergioMussagy, NilzaSantos, Rita RosadoAyres-de-Campos, DiogoRomanelli, Roberta2022-06-06T13:37:18Z20202020-01-01T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10451/53277engJMIR Res Protoc. 2020 Jul 14;9(7):e1647710.2196/164771929-0748info:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2023-11-08T16:58:59Zoai:repositorio.ul.pt:10451/53277Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-19T22:04:15.423900Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse
dc.title.none.fl_str_mv 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
title 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
spellingShingle 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
Reis, Zilma
Childbirth
Equipment and supplies
Fetal growth restriction
Photomedicine
Prematurity
Skin physiological phenomena.
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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
author Reis, Zilma
author_facet Reis, Zilma
Vitral, Gabriela
Guimarães, Rodney
Gaspar, Juliano
Colosimo, Enrico
Taunde, Sergio
Mussagy, Nilza
Santos, Rita Rosado
Ayres-de-Campos, Diogo
Romanelli, Roberta
author_role author
author2 Vitral, Gabriela
Guimarães, Rodney
Gaspar, Juliano
Colosimo, Enrico
Taunde, Sergio
Mussagy, Nilza
Santos, Rita Rosado
Ayres-de-Campos, Diogo
Romanelli, Roberta
author2_role author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Repositório da Universidade de Lisboa
dc.contributor.author.fl_str_mv Reis, Zilma
Vitral, Gabriela
Guimarães, Rodney
Gaspar, Juliano
Colosimo, Enrico
Taunde, Sergio
Mussagy, Nilza
Santos, Rita Rosado
Ayres-de-Campos, Diogo
Romanelli, Roberta
dc.subject.por.fl_str_mv Childbirth
Equipment and supplies
Fetal growth restriction
Photomedicine
Prematurity
Skin physiological phenomena.
topic Childbirth
Equipment and supplies
Fetal growth restriction
Photomedicine
Prematurity
Skin physiological phenomena.
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.
publishDate 2020
dc.date.none.fl_str_mv 2020
2020-01-01T00:00:00Z
2022-06-06T13:37:18Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://hdl.handle.net/10451/53277
url http://hdl.handle.net/10451/53277
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv JMIR Res Protoc. 2020 Jul 14;9(7):e16477
10.2196/16477
1929-0748
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv JMIR Publications
publisher.none.fl_str_mv JMIR Publications
dc.source.none.fl_str_mv reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron:RCAAP
instname_str Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
instacron_str RCAAP
institution RCAAP
reponame_str Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
collection Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
repository.name.fl_str_mv Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação
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