Slow fetal growth and fetal malnutrition. Premature Birth. Hyaline Membrane Disease. Transient Tachypnea of the Newborn.
Conditions
Interventions
Experimental group, single arm: 298 newborns with low birth weight, lower than 2500 grams, assessed during the first 24 hours of life with a prototype of a non invasive medical device which measures t
Device
Sponsors
Faculdade de Medicina da Universidade Federal de Minas Gerais
Fundação Oswaldo Cruz
Eligibility
Age
0 Hours to 24 Hours
Inclusion criteria
Inclusion criteria: Alive newborn. Be until the first 24 hours of life. Be equal or more than 24 weeks of gestational age at birth. Birthweight less than 2500 grams. Fetal had an obstetric ultrasound assessment before 24 weeks of pregnancy or pregnant women had trustable last menstrual period. Regarding the nested control case study be newborn with diagnosing of neonatal respiratory distress syndrome or transient tachypnea assessed until 72 hours after birth. Controls will be randomly paired by ranges of gestational age.
Exclusion criteria
Exclusion criteria: Be malformatted with a compromise of the structure of the skin. Has anhydramnios or fetal hydrops or genodermatoses or chorioamnionitis. In the nested case-control study present extrapulmonary conditions with tachypnea not due to prematurity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome 1: The difference between the gestational age at birth, calculated by the photobiological neonatal skin assessment methodology in relation to the age calculated by the comparators. 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 his skin, within one week error in relation to the comparators. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome 1: Proportion of the small-for-gestational-age newborn correctly detected, based on the photobiological test of the skin and the fetal growth standard of the Intergrowth 21st Group, in relation to the comparators.;Secondary outcome 2: 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, during the first seventy two hours of life.;Secondary outcome 3: 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, during the first seventy two hours of life.;Secondary outcome 4: To describe the relationship between the skin reflectance measurement of the newborn with a ventilatory support need due to pulmonary immaturity, during the first seventy two hours of life. ;Secondary outcome 5: To describe the relationship between the skin reflectance measurement of the newborn with neonatal care intensive unit admission needs, during the first seventy two hours of life, due to pulmonary immaturity. | — |
Countries
Brazil, Mozambique
Contacts
Public ContactZilma Reis
Faculdade de Medicina da Universidade Federal de Minas Gerais
Outcome results
None listed