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Gestational age assessed by optical skin reflection in low-birth-weight newborns: Applications in classification at birth.

Authors :
Vitral GLN
Romanelli RMC
Reis ZSN
Guimarães RN
Dias I
Mussagy N
Taunde S
Neves GS
de São José CN
Pantaleão AN
Pappa GL
Gaspar JS
de Aguiar RAPL
Source :
Frontiers in pediatrics [Front Pediatr] 2023 Mar 28; Vol. 11, pp. 1141894. Date of Electronic Publication: 2023 Mar 28 (Print Publication: 2023).
Publication Year :
2023

Abstract

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).<br />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.<br />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).<br />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.<br />Competing Interests: The authors declare a patent deposit on behalf of the Universidade Federal de Minas Gerais and Fundação de Amparo a Pesquisade Minas Gerais, Brazil. The inventors were ZSNR, RNG, and BR1020170235688 (CTIT-PN862). BirthTech, a spin-off company, received a license to produce and commercialize this technology, and RG is its founder. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.<br /> (© 2023 Vitral, Romanelli, Reis, Guimarães, Dias, Mussagy, Taunde, Neves, de São José, Pantaleão, Pappa, Gaspar and de Aguiar.)

Details

Language :
English
ISSN :
2296-2360
Volume :
11
Database :
MEDLINE
Journal :
Frontiers in pediatrics
Publication Type :
Academic Journal
Accession number :
37056944
Full Text :
https://doi.org/10.3389/fped.2023.1141894