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Gestational age assessed by optical skin reflection in low-birth-weight newborns: Applications in classification at birth
INTRODUCTION: A new medical device was previously developed to estimate gestational age (GA) at birth by processing a machine learning algorithm on the light scatter signal acquired on the newborn's skin. The study aims to validate GA calculated by the new device (test), comparing the result wi...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Frontiers Media S.A.
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10086374/ https://www.ncbi.nlm.nih.gov/pubmed/37056944 http://dx.doi.org/10.3389/fped.2023.1141894 |
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author | Vitral, Gabriela Luiza Nogueira Romanelli, Roberta Maia de Castro Reis, Zilma Silveira Nogueira Guimarães, Rodney Nascimento Dias, Ivana Mussagy, Nilza Taunde, Sergio Neves, Gabriela Silveira de São José, Carolina Nogueira Pantaleão, Alexandre Negrão Pappa, Gisele Lobo Gaspar, Juliano de Souza de Aguiar, Regina Amélia Pessoa Lopes |
author_facet | Vitral, Gabriela Luiza Nogueira Romanelli, Roberta Maia de Castro Reis, Zilma Silveira Nogueira Guimarães, Rodney Nascimento Dias, Ivana Mussagy, Nilza Taunde, Sergio Neves, Gabriela Silveira de São José, Carolina Nogueira Pantaleão, Alexandre Negrão Pappa, Gisele Lobo Gaspar, Juliano de Souza de Aguiar, Regina Amélia Pessoa Lopes |
author_sort | Vitral, Gabriela Luiza Nogueira |
collection | PubMed |
description | INTRODUCTION: A new medical device was previously developed to estimate gestational age (GA) at birth by processing a machine learning algorithm on the light scatter signal acquired on the newborn's skin. The study aims to validate GA calculated by the new device (test), comparing the result with the best available GA in newborns with low birth weight (LBW). METHODS: We conducted a multicenter, non-randomized, and single-blinded clinical trial in three urban referral centers for perinatal care in Brazil and Mozambique. LBW newborns with a GA over 24 weeks and weighing between 500 and 2,500 g were recruited in the first 24 h of life. All pregnancies had a GA calculated by obstetric ultrasound before 24 weeks or by reliable last menstrual period (LMP). The primary endpoint was the agreement between the GA calculated by the new device (test) and the best available clinical GA, with 95% confidence limits. In addition, we assessed the accuracy of using the test in the classification of preterm and SGA. Prematurity was childbirth before 37 gestational weeks. The growth standard curve was Intergrowth-21st, with the 10th percentile being the limit for classifying SGA. RESULTS: Among 305 evaluated newborns, 234 (76.7%) were premature, and 139 (45.6%) were SGA. The intraclass correlation coefficient between GA by the test and reference GA was 0.829 (95% CI: 0.785–0.863). However, the new device (test) underestimated the reference GA by an average of 2.8 days (95% limits of agreement: −40.6 to 31.2 days). Its use in classifying preterm or term newborns revealed an accuracy of 78.4% (95% CI: 73.3–81.6), with high sensitivity (96.2%; 95% CI: 92.8–98.2). The accuracy of classifying SGA newborns using GA calculated by the test was 62.3% (95% CI: 56.6–67.8). DISCUSSION: The new device (test) was able to assess GA at birth in LBW newborns, with a high agreement with the best available GA as a reference. The GA estimated by the device (test), when used to classify newborns on the first day of life, was useful in identifying premature infants but not when applied to identify SGA infants, considering current algohrithm. Nonetheless, the new device (test) has the potential to provide important information in places where the GA is unknown or inaccurate. |
format | Online Article Text |
id | pubmed-10086374 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-100863742023-04-12 Gestational age assessed by optical skin reflection in low-birth-weight newborns: Applications in classification at birth Vitral, Gabriela Luiza Nogueira Romanelli, Roberta Maia de Castro Reis, Zilma Silveira Nogueira Guimarães, Rodney Nascimento Dias, Ivana Mussagy, Nilza Taunde, Sergio Neves, Gabriela Silveira de São José, Carolina Nogueira Pantaleão, Alexandre Negrão Pappa, Gisele Lobo Gaspar, Juliano de Souza de Aguiar, Regina Amélia Pessoa Lopes Front Pediatr Pediatrics INTRODUCTION: A new medical device was previously developed to estimate gestational age (GA) at birth by processing a machine learning algorithm on the light scatter signal acquired on the newborn's skin. The study aims to validate GA calculated by the new device (test), comparing the result with the best available GA in newborns with low birth weight (LBW). METHODS: We conducted a multicenter, non-randomized, and single-blinded clinical trial in three urban referral centers for perinatal care in Brazil and Mozambique. LBW newborns with a GA over 24 weeks and weighing between 500 and 2,500 g were recruited in the first 24 h of life. All pregnancies had a GA calculated by obstetric ultrasound before 24 weeks or by reliable last menstrual period (LMP). The primary endpoint was the agreement between the GA calculated by the new device (test) and the best available clinical GA, with 95% confidence limits. In addition, we assessed the accuracy of using the test in the classification of preterm and SGA. Prematurity was childbirth before 37 gestational weeks. The growth standard curve was Intergrowth-21st, with the 10th percentile being the limit for classifying SGA. RESULTS: Among 305 evaluated newborns, 234 (76.7%) were premature, and 139 (45.6%) were SGA. The intraclass correlation coefficient between GA by the test and reference GA was 0.829 (95% CI: 0.785–0.863). However, the new device (test) underestimated the reference GA by an average of 2.8 days (95% limits of agreement: −40.6 to 31.2 days). Its use in classifying preterm or term newborns revealed an accuracy of 78.4% (95% CI: 73.3–81.6), with high sensitivity (96.2%; 95% CI: 92.8–98.2). The accuracy of classifying SGA newborns using GA calculated by the test was 62.3% (95% CI: 56.6–67.8). DISCUSSION: The new device (test) was able to assess GA at birth in LBW newborns, with a high agreement with the best available GA as a reference. The GA estimated by the device (test), when used to classify newborns on the first day of life, was useful in identifying premature infants but not when applied to identify SGA infants, considering current algohrithm. Nonetheless, the new device (test) has the potential to provide important information in places where the GA is unknown or inaccurate. Frontiers Media S.A. 2023-03-28 /pmc/articles/PMC10086374/ /pubmed/37056944 http://dx.doi.org/10.3389/fped.2023.1141894 Text en © 2023 Vitral, Romanelli, Reis, Guimarães, Dias, Mussagy, Taunde, Neves, de São José, Pantaleão, Pappa, Gaspar and de Aguiar. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY) (https://creativecommons.org/licenses/by/4.0/) . The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pediatrics Vitral, Gabriela Luiza Nogueira Romanelli, Roberta Maia de Castro Reis, Zilma Silveira Nogueira Guimarães, Rodney Nascimento Dias, Ivana Mussagy, Nilza Taunde, Sergio Neves, Gabriela Silveira de São José, Carolina Nogueira Pantaleão, Alexandre Negrão Pappa, Gisele Lobo Gaspar, Juliano de Souza de Aguiar, Regina Amélia Pessoa Lopes Gestational age assessed by optical skin reflection in low-birth-weight newborns: Applications in classification at birth |
title | Gestational age assessed by optical skin reflection in low-birth-weight newborns: Applications in classification at birth |
title_full | Gestational age assessed by optical skin reflection in low-birth-weight newborns: Applications in classification at birth |
title_fullStr | Gestational age assessed by optical skin reflection in low-birth-weight newborns: Applications in classification at birth |
title_full_unstemmed | Gestational age assessed by optical skin reflection in low-birth-weight newborns: Applications in classification at birth |
title_short | Gestational age assessed by optical skin reflection in low-birth-weight newborns: Applications in classification at birth |
title_sort | gestational age assessed by optical skin reflection in low-birth-weight newborns: applications in classification at birth |
topic | Pediatrics |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10086374/ https://www.ncbi.nlm.nih.gov/pubmed/37056944 http://dx.doi.org/10.3389/fped.2023.1141894 |
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