{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"institution":[{"name":"Research Square"}],"indexed":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T00:53:40Z","timestamp":1740099220846,"version":"3.37.3"},"posted":{"date-parts":[[2022,4,13]]},"group-title":"In Review","reference-count":0,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2022,4,13]],"date-time":"2022-04-13T00:00:00Z","timestamp":1649808000000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100006506","name":"Minist\u00e9rio da Sa\u00fade","doi-asserted-by":"publisher","award":["PROCIS, project 23072.052747\/2017-51"],"award-info":[{"award-number":["PROCIS, project 23072.052747\/2017-51"]}],"id":[{"id":"10.13039\/501100006506","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"accepted":{"date-parts":[[2021,12,30]]},"abstract":"<title>Abstract<\/title>\n        <p>Background: The early access to prenatal care and high-cost technologies for pregnancy dating challenge the early neonatal risks assessment at birth in resource-constrained settings. To overcome the absence or low accuracy of postnatal gestational age, we developed a frugal innovation based on the photobiological properties of the newborn's skin and predictive models. Methods: A multicenter single-blinding, and single-arm clinical trial intention-to-diagnosis evaluated the accuracy of a novel device to detect gestational age and preterm newborns. The first-trimester ultrasound (US), a second comparator US, and the last menstrual period (LMP) data from antenatal reports were the references for gestational age at birth. A portable multiband reflectance photometer assessed 781 newborns\u2019 skin maturity and used machine learning models to predict gestational age, adjusted to birth weight and antenatal corticosteroid therapy exposure.  Results: As the primary outcome, the predicted gestational by the new test had high agreement with the reference gestational age calculated with the intraclass correlation coefficient (0.970 [95%CI: 0.965, 0.974]) similar values to the comparator-US and better than the comparator-LMP gestational ages. As secondary outcomes, the new test achieved 97.7% (95%CI: 96.5%, 98.6%) agreement with the reference gestational age within one-week error. This value surpassed those of comparator-US (91.3% [95%CI: 89.2%, 93.1%]), and of comparator-LMP gestational ages (64.1% [60.7% to 67.5%]). Bland-Altman limits of the new test were -7.1 to 4.7 days. Prematurity discrimination with the novel device had the area under the receiver operating characteristic curve (AUROC) (0.998 [95%CI: 0.997, 1.000]), similar to comparator-US (0.996 [95% CI: 0.993, 0.999)]; and superior to comparator-LMP gestational ages (0.957 [95%CI:0.941, 0.974]). In newborns with absent or unreliable LMP (n=451), the intent-to-discriminate analysis showed correct classifications with the new test of 96.5% (95%CI: 94.3%, 98.0%), while with the comparator-LMP gestational age was 69.6% (95% CI: 65.3%, 73.7%).  Interpretation: The assessment of the newborn's skin maturity adjusted by learning models promises accurate pregnancy dating at birth even without the antenatal ultrasound reference. Funding: Grand Challenges Exploration from the Bill &amp; Melinda Gates Foundation, <italic>Funda\u00e7\u00e3o de Amparo a Pesquisa de Minas Gerais<\/italic>, Brazilian Ministry of Health, CNPq - C<italic>onselho Nacional de Desenvolvimento Cient\u00edfico e Tecnol\u00f3gico.<\/italic><\/p>","DOI":"10.21203\/rs.3.rs-1216628\/v3","type":"posted-content","created":{"date-parts":[[2022,4,13]],"date-time":"2022-04-13T17:12:36Z","timestamp":1649869956000},"source":"Crossref","is-referenced-by-count":0,"title":["Newborn skin maturity model for gestational age prediction: a clinical trial for a novel medical device validation"],"prefix":"10.21203","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6374-9295","authenticated-orcid":false,"given":"Zilma Silveira Nogueira","family":"Reis","sequence":"first","affiliation":[{"name":"Department of Gynecology and Obstetrics, Faculty of Medicine, Universidade Federal de Minas Gerais, Brazil. Center for Artificial Intelligence, Innovation and Health, Universidade Federal de Minas Gerais, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5617-4470","authenticated-orcid":false,"given":"Rodney Nascimento","family":"Guimar\u00e3es","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Faculty of Medicine, Universidade Federal de Minas Gerais, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1660-0751","authenticated-orcid":false,"given":"Roberta Maia de Castro","family":"Romanelli","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Faculty of Medicine, Universidade Federal de Minas Gerais, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0670-9021","authenticated-orcid":false,"given":"Juliano de Souza","family":"Gaspar","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Faculty of Medicine, Universidade Federal de Minas Gerais, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6765-2968","authenticated-orcid":false,"given":"Gabriela Silveira","family":"Neves","sequence":"additional","affiliation":[{"name":"Hospital Sofia Feldman, Brazil. Department of Pediatrics, Faculty of Medicine, Universidade Federal de Minas Gerais, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1544-5470","authenticated-orcid":false,"given":"Marynea Silva do","family":"Vale","sequence":"additional","affiliation":[{"name":"Maternal and Child Unit, University Hospital, Universidade Federal do Maranh\u00e3o, EBSERH, Brazil."}]},{"given":"Paulo de Jesus H","family":"Nader","sequence":"additional","affiliation":[{"name":"University Hospital of Canoas, Universidade Luterana do Brasil, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7851-375X","authenticated-orcid":false,"given":"Martha David Rocha","family":"de Moura","sequence":"additional","affiliation":[{"name":"Hospital Materno Infantil de Bras\u00edlia, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7306-8776","authenticated-orcid":false,"given":"Gabriela Lu\u00edza Nogueira","family":"Vitral","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Faculty of Medicine, Universidade Federal de Minas Gerais, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5294-1361","authenticated-orcid":false,"given":"Marconi Augusto Aguiar dos","family":"Reis","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Faculty of Medicine, Universidade Federal de Minas Gerais, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2699-2963","authenticated-orcid":false,"given":"Marcia Margarida Mendon\u00e7a","family":"Pereira","sequence":"additional","affiliation":[{"name":"Maternal and Child Unit, University Hospital, Universidade Federal do Maranh\u00e3o, EBSERH, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6812-6687","authenticated-orcid":false,"given":"Patr\u00edcia Franco","family":"Marques","sequence":"additional","affiliation":[{"name":"Maternal and Child Unit, University Hospital, Universidade Federal do Maranh\u00e3o, EBSERH, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9360-6201","authenticated-orcid":false,"given":"Silvana Salgado","family":"Nader","sequence":"additional","affiliation":[{"name":"University Hospital of Canoas, Universidade Luterana do Brasil, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3220-1643","authenticated-orcid":false,"given":"Augusta Luize","family":"Harff","sequence":"additional","affiliation":[{"name":"University Hospital of Canoas, Universidade Luterana do Brasil, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9975-562X","authenticated-orcid":false,"given":"Ludmylla de Oliveira","family":"Beleza","sequence":"additional","affiliation":[{"name":"Hospital Materno Infantil de Bras\u00edlia, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8727-8328","authenticated-orcid":false,"given":"Maria Eduarda Canellas","family":"de Castro","sequence":"additional","affiliation":[{"name":"Hospital Materno Infantil de Bras\u00edlia, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2440-2242","authenticated-orcid":false,"given":"Rayner Guilherme","family":"Souza","sequence":"additional","affiliation":[{"name":"Department of Gynecology and Obstetrics, Faculty of Medicine, Universidade Federal de Minas Gerais, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0349-4494","authenticated-orcid":false,"given":"Gisele Lobo","family":"Pappa","sequence":"additional","affiliation":[{"name":"Center for Artificial Intelligence, Innovation and Health, Universidade Federal de Minas Gerais, Brazil. Computer Science Department, Universidade Federal de Minas Gerais, Brazil."}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2470-3539","authenticated-orcid":false,"given":"Regina Am\u00e9lia Pessoa Lopes","family":"de Aguiar","sequence":"additional","affiliation":[{"name":"State Health Department of Minas Gerais, Brazil"}]}],"member":"297","container-title":[],"original-title":[],"link":[{"URL":"https:\/\/www.researchsquare.com\/article\/rs-1216628\/v3","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.researchsquare.com\/article\/rs-1216628\/v3.html","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,4,13]],"date-time":"2022-04-13T17:13:55Z","timestamp":1649870035000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.researchsquare.com\/article\/rs-1216628\/v3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4,13]]},"references-count":0,"URL":"https:\/\/doi.org\/10.21203\/rs.3.rs-1216628\/v3","relation":{},"subject":[],"published":{"date-parts":[[2022,4,13]]},"subtype":"preprint"}}