Prematurity detection using the interaction between light and the skin of the newborn

Conditions

Premature Birth

Gabriela Silveira Neves, Zilma Silveira Nogueira Reis, Roberta Maia de Castro Romanelli, James Batchelor

JMIR Biomedical Engineering2023-12-25

Respiratory distress syndrome prediction at birth by optical skin maturity assessment and machine learning models for limited-resource settings: a development and validation study

Zilma Silveira Nogueira Reis, Gisele L. Pappa, Paulo de Jesus H Nader, Marynéa Silva do Vale, Gabriela Silveira Neves et al. (9 authors)

Frontiers in Pediatrics2023-11-151 citations

10.3389/fped.2023.1264527

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

Zilma Silveira Nogueira Reis, Gabriela Luíza Nogueira Vitral, Rodney Nascimento Guimarães, Juliano de Souza Gaspar, Enrico A. Colosimo et al. (10 authors)

JMIR Research Protocols2020-05-069 citations

10.2196/16477

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 et al. (13 authors)

BMJ Open2019-03-0111 citations

10.1136/bmjopen-2018-027442

Interventions

Experimental group, single arm with 787 newborns assessed during the first twenty four hours of life with a non invasive prototype of medical device which measures the reflectance of the skin when it

E05.196.712

F02.463.593.524

Eligibility

Age

No minimum to 24 Hours

Inclusion criteria

Inclusion criteria: Alive newborn; enrollment during first twenty four hours of life; be equal or more than twenty four weeks of gestational; fetal had an obstetric ultrasound assessment before fourteen weeks of pregnancy; fetal had obstetric ultrasound assessment equal or after fourteen gestational weeks.In a nested case control study, newborns selected within the first 72 hours of life, discharge or death if they occur first with respiratory distress syndrome or transient tachypnea diagnosis; control newborn will randomly paired by ranges of gestational age

Exclusion criteria

Exclusion criteria: Be malformatted with structural skin alterations; with skin modifiers as follow, anhydramnios, hydrops, or chorioamnionitis. In the nested case control study the existence of extrapulmonary conditions with tachypnea not due to prematurity

Design outcomes

Primary

Measure	Time frame
Primary outcome 1: The difference between the gestational age calculated by the photobiological neonatal skin assessment in relation to the age calculated by the comparators, at birth. Data availability statement: the authors plan to share the minimal deidentified data set necessary to replicate study findings. The coordinator of the clinical trial will provide data access under reasonable request since the original study citation is warranted.;Primary outcome 2: Proportion of the preterm newborn correctly detected at birth, based on the photobiological test of the skin, within one week error, in relation to the comparators.	—

Measure

Time frame

Primary outcome 1: The difference between the gestational age calculated by the photobiological neonatal skin assessment in relation to the age calculated by the comparators, at birth. Data availability statement: the authors plan to share the minimal deidentified data set necessary to replicate study findings. The coordinator of the clinical trial will provide data access under reasonable request since the original study citation is warranted.;Primary outcome 2: Proportion of the preterm newborn correctly detected at birth, based on the photobiological test of the skin, within one week error, in relation to the comparators.

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Secondary

Measure	Time frame
Secondary outcome 1: The difference between the error of the new test in relation to the error of the comparators to detect gestational age at birth, taking two groups randomly selected in the study database.;Secondary outcome 2: To establish the ease of use of the Preemie-Test measurement as a potential method of preterm newborn diagnosis.;Secondary outcome 3: To describe the relationship between the skin reflectance measurement of the newborn with the respiratory distress syndrome, with diagnosis based on clinical and radiological findings, until seventy two hours after birth.;Secondary outcome 4: To describe the relationship between the skin reflectance measurement of the newborn with the transient tachypnea of the newborn, with diagnosis based on clinical findings, until seventy two hours after birth.;Secondary outcome 5: To describe the relationship between the skin reflectance measurement of the newborn with a ventilatory support need due to pulmonary immaturity, until seventy two hours after birth.;Secondary outcome 6: To describe the relationship between the skin reflectance measurement of the newborn with neonatal care intensive unit admission need due to pulmonary immaturity, until seventy two hours after birth.	—

Measure

Time frame

Secondary outcome 1: The difference between the error of the new test in relation to the error of the comparators to detect gestational age at birth, taking two groups randomly selected in the study database.;Secondary outcome 2: To establish the ease of use of the Preemie-Test measurement as a potential method of preterm newborn diagnosis.;Secondary outcome 3: To describe the relationship between the skin reflectance measurement of the newborn with the respiratory distress syndrome, with diagnosis based on clinical and radiological findings, until seventy two hours after birth.;Secondary outcome 4: To describe the relationship between the skin reflectance measurement of the newborn with the transient tachypnea of the newborn, with diagnosis based on clinical findings, until seventy two hours after birth.;Secondary outcome 5: To describe the relationship between the skin reflectance measurement of the newborn with a ventilatory support need due to pulmonary immaturity, until seventy two hours after birth.;Secondary outcome 6: To describe the relationship between the skin reflectance measurement of the newborn with neonatal care intensive unit admission need due to pulmonary immaturity, until seventy two hours after birth.

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Countries

Brazil

Contacts

Public ContactZilma Reis

Faculdade de Medicina da Universidade Federal de Minas Gerais

zilma.medicina@gmail.com5531985177473

Outcome results

None listed