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

Abstract

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.

Newborn skin maturity models for gestational age prediction

“…Among 366 (46.9%) preterm newborns, 235 (30.1%) had a gestational age at birth less than 37 to 32 weeks, and 131 (16.8%) had a gestational age less than 32 to 24 weeks, achieving approximately the expected arranged proportion for the sampling. 20 The frequency of fetal abnormal growth classi cation at birth was 116 (14.9%) who were small for gestational age and 59 (7.6%) who were large for gestational age.…”

Newborn skin maturity models for gestational age prediction

“…Among 366 (46.9%) preterm newborns, 235 (30.1%) had a gestational age at birth less than 37 to 32 weeks, and 131 (16.8%) had a gestational age less than 32 to 24 weeks, achieving approximately the expected arranged proportion for the sampling. 20 A number of the newborns (n= 273, 35.0%) received ACTFM, following local protocols. The frequency of fetal abnormal growth classi cation at birth was 116 (14.9%) who were small for gestational age and 59 (7.6%) who were large for gestational age.…”

“…Eligibility criteria, participants' timeline, and the procedures followed the clinical protocol. 20 In short, we assessed the skin maturity of live newborns with at least 24 weeks or more of gestational age. All of them had their gestational age estimated by clinical parameters, with the embryo measurement mandatorily assessed by ultrasound exam at <14 weeks of gestation.…”

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

“…For this, the GA modeling prediction is based on the result of another ongoing clinical trial (registration number RBR-3f5bm5). This study is taking place at 5 Brazilian centers with the analysis of the skin reflection and clinical data of 787 newborns, with 24-42 weeks of gestation, using strict rules of the crown–rump length ultrasound measurement for pregnancy dating [ 17 ]. We expect to establish the prediction model toward the end of the RBR-3f5bm5 clinical trial in September 2020.…”

“…Clinical variables are presented in a digital screen immediately after the newborn skin assessment. Since February 2019, a clinical trial is taking place in 5 Brazilian hospitals to advance the GA prediction modeling, using a sample of 787 newborns [ 17 ]. The planned date of last enrollment is July 2020.…”