Newborn skin reflection: Proof of concept for a new approach for predicting gestational age at birth. A cross-sectional study

Reis, Zilma Silveira Nogueira; Vitral, Gabriela Luiza Nogueira; Souza, Ingrid Michelle Fonseca de; Rego, Maria Albertina Santiago; Guimarães, R.

doi:10.1371/journal.pone.0184734

Cited by 14 publications

(41 citation statements)

References 29 publications

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“…Moreover, our research group reported that neonatal skin reflectance, adjusted by clinical variables, was related to GA, with higher correlation than skin thickness ( R 2 = 0.828, P < 0.001) [ 42 ]. However, both analyses revealed bio-optical properties of the skin at birth as a target to improve maturity scores of GA prediction.…”

Section: Discussionmentioning

confidence: 99%

Skin thickness as a potential marker of gestational age at birth despite different fetal growth profiles: A feasibility study

et al. 2018

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BackgroundNew methodologies to estimate gestational age (GA) at birth are demanded to face the limited access to obstetric ultrasonography and imprecision of postnatal scores. The study analyzed the correlation between neonatal skin thickness and pregnancy duration. Secondarily, it investigated the influence of fetal growth profiles on tissue layer dimensions.Methods and findingsIn a feasibility study, 222 infants selected at a term-to-preterm ratio of 1:1 were assessed. Reliable information on GA was based on the early ultrasonography-based reference. The thicknesses of the epidermal and dermal skin layers were examined using high-frequency ultrasonography. We scanned the skin over the forearm and foot plantar surface of the newborns. A multivariate regression model was adjusted to determine the correlation of GA with skin layer dimensions. The best model to correlate skin thickness with GA was fitted using the epidermal layer on the forearm site, adjusted to cofactors, as follows: Gestational age (weeks) = −28.0 + 12.8 Ln (Thickness) − 4.4 Incubator staying; R2 = 0.604 (P<0.001). In this model, the constant value for the standard of fetal growth was statistically null. The dermal layer thickness on the forearm and plantar surfaces had a negative moderate linear correlation with GA (R = −0.370, P<0.001 and R = −0.421, P<0.001, respectively). The univariate statistical analyses revealed the influence of underweight and overweight profiles on neonatal skin thickness at birth. Of the 222 infants, 53 (23.9%) had inappropriate fetal growths expected for their GA. Epidermal thickness was not fetal growth standard dependent as follows: 172.2 (19.8) μm for adequate for GA, 171.4 (20.6) μm for SGA, and 177.7 (15.2) μm for LGA (P = 0.525, mean [SD] on the forearm).ConclusionsThe analysis highlights a new opportunity to relate GA at birth to neonatal skin layer thickness. As this parameter was not influenced by the standard of fetal growth, skin maturity can contribute to clinical applications.

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Section: Discussionmentioning

confidence: 99%

Skin thickness as a potential marker of gestational age at birth despite different fetal growth profiles: A feasibility study

et al. 2018

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“…Variations in light scattering through the skin are believed to be associated with changes in skin thickness, the concentration of chromophores, and light wavelength [ 14 ]. A novel technology was developed to estimate GA at birth (Test-GA) by analyzing the photobiological properties of the newborn’s skin in combination with clinical variables [ 15 ]. This noninvasive and nonionizing technology features a probe containing light emitters and receivers that is brought in contact with the skin over the sole.…”

Section: Introductionmentioning

confidence: 99%

“…This noninvasive and nonionizing technology features a probe containing light emitters and receivers that is brought in contact with the skin over the sole. A mathematical algorithm provides an estimated GA within seconds, combining the skin reflection with clinical adjusters, such as birth weight and incubator stay [ 15 ].…”

Section: Introductionmentioning

confidence: 99%

“…The timeline of the new medical device development involves sequential steps [ 16 ], represented in Figure 1 . The prototype of the device previously evaluated 115 newborns at 24-41 weeks’ gestation with promising results [ 15 ]. After insights from this first clinical experiment published in 2017, the technology received improvements to mitigate external influences in the test, such as humidity, ambient light, and to ease the user handling.…”

Section: Introductionmentioning

confidence: 99%

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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

et al. 2020

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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. Trial Registration ReBec: RBR-33rnjf; http://www.ensaiosclinicos.gov.br/rg/RBR-33rnjf/ International Registered Report Identifier (IRRID) DERR1-10.2196/16477

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“…The device under test is easy to use and every effort is being made to ensure that it has excellent accuracy, be it safe and low cost. The feasibility study provided a mathematical model to predict GA based on the skin reflectance adjusted to clinical variables (R 2 =0.828, p<0.001) 15. However, before the adoption or use of an innovation, an effectiveness trial of intervention is a critical step in the research chain regarding its the social utility when completing the translation from the proof of concept to clinical science 15.…”

Section: Introductionmentioning

confidence: 99%

Prematurity detection evaluating interaction between the skin of the newborn and light: protocol for the preemie-test multicentre clinical trial in Brazilian hospitals to validate a new medical device

Reis¹,

Guimarães

Rego

et al. 2019

BMJ Open

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IntroductionRecognising prematurity is critical in order to attend to immediate needs in childbirth settings, guiding the extent of medical care provided for newborns. A new medical device has been developed to carry out the preemie-test, an innovative approach to estimate gestational age (GA), based on the photobiological properties of the newborn’s skin. First, this study will validate the preemie-test for GA estimation at birth and its accuracy to detect prematurity. Second, the study intends to associate the infant’s skin reflectance with lung maturity, as well as evaluate safety, precision and usability of a new medical device to offer a suitable product for health professionals during childbirth and in neonatal care settings.Methods and analysisResearch protocol for diagnosis, singlegroup, singleblinding and singlearm multicenter clinical trial with a reference standard. Alive newborns, with 24 weeks or more of pregnancy age, will be enrolled during the first 24 hours of life. Sample size is 787 subjects. The primary outcome is the difference between the GA calculated by the photobiological neonatal skin assessment methodology and the GA calculated by the comparator antenatal ultrasound or reliable last menstrual period (LMP). Immediate complications caused by pulmonary immaturity during the first 72 hours of life will be associated with skin reflectance in a nested case–control study.Ethics and disseminationEach local independent ethics review board approved the trial protocol. The authors intend to share the minimal anonymised dataset necessary to replicate study findings.Trial registration numberRBR-3f5bm5.

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Newborn skin reflection: Proof of concept for a new approach for predicting gestational age at birth. A cross-sectional study

Cited by 14 publications

References 29 publications

Skin thickness as a potential marker of gestational age at birth despite different fetal growth profiles: A feasibility study

Skin thickness as a potential marker of gestational age at birth despite different fetal growth profiles: A feasibility study

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

Prematurity detection evaluating interaction between the skin of the newborn and light: protocol for the preemie-test multicentre clinical trial in Brazilian hospitals to validate a new medical device

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