BMJ Open (Protocol)
05 de março de 2019 – Online
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
Zilma Silveira Nogueira Reis, Rodney Nascimento Guimarães, Maria Albertina Santiago Rego, Roberta Maia de Castro Romanelli, Juliano de Souza Gaspar, Gabriela Luiza Nogueira Vitral, Marconi Augusto Aguiar dos Reis, Enrico Antônio Colósimo, Gabriela Silveira Neves, Marynea Silva Vale, Paulo de Jesus Hartamann Nader, Marta David Rocha de Moura, Regina Amélia Pessoa Lopes de Aguiar
Recognising 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 analysis
Research 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.
Strengths and limitations
Availability of trustworthy GA information is a prerequisite for preterm birth classification and healthcare decisions.24 In this light, the results of this clinical study have the potential to validate a new device for pregnancy dating. The preemie-test was prepared to operate with minimum operator intervention and for use by healthcare professionals anywhere a birth takes place without a reliable GA .
The purpose of medical research involving neonates is intended to improve clinical procedures.25 In this context, a clinical trial is a research study in which subjects are prospectively assigned to intervention and the effects of those interventions on health-related outcomes are thereby evaluated.26 However, clinical trials on medical devices face barriers when an effective standard procedure does not exist, as is the case of the comparator procedure.27 Our challenge in preparing the present protocol was the absence of a gold standard for pregnancy dating, since the fetal age begins on conception; however, this information is difficult to be accurately determined.7
The study began with the training of health professionals in September 2018.
Planned Date of First Enrolment: 1 February 2019.
Planned Date of Last Enrolment: 31 Decembe 2019.
Data analysis will be finalised, the results of which are expected in May 2020.
PLoS ONE (Research Article)
26 de abril de 2018 – California – US
Skin thickness as a potential marker of gestational age at birth despite different fetal growth profiles: A feasibility study
Gabriela Luiza Nogueira Vitral, Regina Amélia P. Lopes Aguiar, Ingrid Michelle Fonseca de Souza, Maria Albertina Santiago Rego, Rodney Nascimento Guimarães, Zilma Silveira Nogueira Reis
New 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 findings
In 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).
The 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.
PLoS ONE (Research Article)
20 de setembro de 2017 – California – US
Newborn skin reflection: Proof of concept for a new approach for predicting gestational age at birth. A cross-sectional study
Zilma Silveira Nogueira Reis, Gabriela Luiza Nogueira Vitral, Ingrid Michelle Fonseca de Souza, Maria Albertina Santiago Rego, Rodney Nascimento Guimaraes
Current methods to assess the gestational age during prenatal care or at birth are a global challenge. Disadvantages, such as low accessibility, high costs, and imprecision of clinical tests and ultrasonography measurements, may compromise health decisions at birth, based on the gestational age. Newborns’ organs and tissues can indirectly indicate their physical maturity, and we hypothesized that evolutionary changes in their skin, detected using an optoelectronic device meter, may aid in estimating the gestational age. This study analyzed the feasibility of using newborn skin reflectance to estimate the gestational age at birth noninvasively.
Methods and findings
A cross-sectional study evaluated the skin reflectance of selected infants, preferably premature, at birth. The first-trimester ultrasound was the reference for gestational age. A prototype of a new noninvasive optoelectronic device measured the backscattering of light from the skin, using a light emitting diode at wavelengths of 470 nm, 575 nm, and 630 nm. Univariate and multivariate regression analysis models were employed to predict gestational age, combining skin reflectance with clinical variables for gestational age estimation. The gestational age at birth of 115 newborns from 24.1 to 41.8 weeks of gestation correlated with the light at 630 nm wavelength reflectance 3.3 mm/6.5 mm ratio distant of the sensor, at the forearm and sole (Pearson’s correlation = 0.505, P < 0.001 and 0.710, P < 0.001, respectively). The best-combined variables to predict the gold standard gestational age at birth was the skin reflectance at wavelengths of 630 nm and 470 nm in combination with birth weight, phototherapy, and adjusted to include incubator stay, and sex (R2 = 0.828, P < 0.001). The main limitation of the study is that it was very specific to the premature population we studied and needs to be studied in a broader spectrum of newborns.
A novel automated skin reflectometer device, in combination with clinical variables, was able to predict the gestational age and could be useful when the information is in doubt or is unknown. Multivariable predictive models associated the skin reflectance with easy to obtain clinical parameters, at the birth scenario. External validation needs to be proven in an actual population with the real incidence of premature infants.
Third WHO Global Forum on Medical Devices
10 a 12 de maio de 2017 – Genebra – Suíça
Prematurity detection by light
Prof. Zilma Reis, Rodney Nascimento Guimarães, Gabriela Luíza Nogueira Vitral, Maria Albertina Santiago Rego, Ingrid Michelle Fonseca
Universidade Federal de Minas Gerais, Brazil
When a baby is born very small, less than 2.5 kg, he can be premature and birth attendants need warns to timely support him and make decisions as refer the baby to the hospital. Without the critical care, the newborn viability could be neglected, as well his potential of a healthy life. The best time to determine gestational age using ultrasound is during the first three months of gestation, a difficult approach to carrying on in low-income settings. We developed a low-cost, safety, and portable optoelectronic device that can immediately estimate if the newborn is premature. The technology is based on the skin reflectance. Our solution delivers a Premie-Test that addresses one answer to support a big global health problem: the quality of care at birth, facing the doubt or unknown on the chronology of gestation. The device is easy to manufacture without high-technological support. The approach is noninvasive, automated and it can be used wherever a birth happens, by health workers and midwives in health centres or at home. Our goal is to provide a device and prepare a guidance to assist decision to face the delivery of care when the baby is born small, improving neonatal survival. Contact: https://skinage.medicina.ufmg.br/index.php/en/.
A multiband reflectance photometric device for reveal gestational age at birth
Prof. Rodney Guimaraes, Zilma Reis
Universidade Federal de Minas Gerais (UFMG), Brazil
This work was motivated by the desire to develop a low cost device that can immediately estimate the age of a newborn at birth.
The most crucial information at birth are gestational age (GA) and weight, without this information the infant viability could be
neglected, as well his potential of a healthy life.
Nowadays, the gold standard to determine the GA is the first-trimester ultrasound. However, there is a discrepancy of approx-
imately five to seven days with the last menstrual period, and after that time the precision of the GA information will be even
more inaccurate. In addition, the ultrasound is a difficult approach to carrying on in clinical practice and considered inaccessible
in low-income settings.
Our solution addresses one answer to a low-cost technology to support a big global health problem: the quality of care at birth
and neonatal period, facing the doubt or unknown on the chronology of gestation. Premature newborns are more vulnerable to
death during the first days, and following days of life, severe childhood neurological disability, and lifelong complications.
X Congresso Mineiro de Ginecologia e Obstetrícia
10 a 13 de maio de 2017 – Belo Horizonte – Brasil
Avaliação da idade gestacional no momento do parto por diferentes referenciais clínicos: um desafio atual
Ingrid Michelle F. de Souza¹ , Carolina N. de São José³, Paola C. Silva², Gabriela L. N. Vitral¹, Wagner B. Magalhães¹, Maria Albertina S. Rego¹, Rodney N. Guimarães¹, Zilma S. N. Reis¹
¹Faculdade de Medicina da Universidade Federal de Minas Gerais; ²Hospital Sofia Feldman; ³Faculdade de Ciências Médicas de Minas Gerais
A cronologia da gestação é o principal marcador de sobrevida do recém nascido e acredita-se que sua determinação precisa afeta os resultados perinatais. A informação correta da idade gestacional (IG) permite que a gravidez seja conduzida adequadamente, além de fundamentar intervenções neonatais apropriadas. Além disso, é a base para a estatística de prematuridade, orientando políticas públicas. Os métodos atuais de estimativa da IG dependem da data da última menstruação (DUM), muitas vezes incerta, ou desconhecida ou de preferência de um ultrassom (US), realizado no primeiro trimestre da gravidez, o que nem sempre é acessível.
XV Congresso Brasileiro de Informática em Saúde
27 a 30 de novembro de 2016 – Goiânia – Brasil
Meu Pré-natal – Aplicativo para dispositivos móveis
Marcelo R Santos Jr¹ , Dimitri Santos¹ , Isaias J R Oliveira¹ , Zilma Reis¹
¹Faculdade de Medicina da UFMG, Belo Horizonte, MG
Uma nova forma de comunicação entre os profissionais de saúde e seus pacientes advém da popularização dos dispositivos móveis e dos aplicativos de apoio ao cuidado. Esta demonstração apresenta um aplicativo para o uso em dispositivos móveis, capaz de subsidiar informações relevantes sobre a gestação, parto e amamentação, de forma a contribuir para o processo de educação em saúde para as mulheres. Desenvolvido por uma equipe multidisciplinar acadêmica em uma universidade pública, o aplicativo já se encontra disponível gratuitamente e o usuário-alvo são as gestantes e puérperas. O aplicativo Meu Pré-natal proporciona informações confiáveis sobre cuidados na gravidez, parto e puerpério, incentivando o cuidado pré-natal e de forma complementar ao cuidado do profissional de saúde, sem jamais substituí-lo. Disponibiliza textos com linguagem acessível ao público leigo, imagens e vídeo, com interface que permite navegação fácil e intuitiva entre seus módulos. Acredita-se que o projeto seja capaz de apoiar a gestante e seu bebê no centro da atenção pré-natal, permitindo uma participação mais ativa e que ofereça informações e funcionalidades que a apoiarão durante toda sua gravidez, parto e pós-parto.
Aplicativo, Educação em saúde, Pré-natal, Relações Comunidade-Instituição, Dispositivos móveis.
Determinação automática da espessura da epiderme em imagens ultrassonográficas
Gabriela Vitral¹ , Michelle Fonseca¹ , Wagner Magalhães¹ , Rodney Guimarães¹ , Zilma Reis¹
¹Faculdade de Medicina da Universidade Federal de Minas Gerais, UFMG, Belo Horizonte, MG
A estimativa das dimensões de órgãos humanas através de imagens médicas trouxe avanços importantes no diagnóstico de doenças. A automação de medidas tem o potencial de reduzir interferências examinador-dependentes. O objetivo desse estudo foi desenvolver um software para estimar automaticamente a espessura da epiderme humana, a partir de uma imagem obtida por ultrassom. O software foi desenvolvido em linguagem Phyton, sendo capaz de detectar as bordas irregulares da epiderme e estimar sua espessura utilizando uma técnica estatística conhecida como bootstrap. Foram realizados testes em 90 imagens. O software se mostrou prático e satisfatório para profssionais de saúde, possibilitando sua utilização de forma racional e oportuna na medida indireta da espessura da epiderme humana.
Pele; Software; Informática Médica; Diagnostico por imagem.