Background Early access to antenatal care and high-cost technologies for pregnancy dating challenge early neonatal risk assessment at birth in resource-constrained settings. To overcome the absence or inaccuracy of postnatal gestational age (GA), we developed a new medical device to assess GA based on the photobiological properties of newborns’ skin and predictive models. Objective This study aims to validate a device that uses the photobiological model of skin maturity adjusted to the clinical data to detect GA and establish its accuracy in discriminating preterm newborns. Methods A multicenter, single-blinded, and single-arm intention-to-diagnosis clinical trial evaluated the accuracy of a novel device for the detection of GA and preterm newborns. The first-trimester ultrasound, a second comparator ultrasound, and data regarding the last menstrual period (LMP) from antenatal reports were used as references for GA at birth. The new test for validation was performed using a portable multiband reflectance photometer device that assessed the skin maturity of newborns and used machine learning models to predict GA, adjusted for birth weight and antenatal corticosteroid therapy exposure. Results The study group comprised 702 pregnant women who gave birth to 781 newborns, of which 366 (46.9%) were preterm newborns. As the primary outcome, the GA as predicted by the new test was in line with the reference GA that was calculated by using the intraclass correlation coefficient (0.969, 95% CI 0.964-0.973). The paired difference between predicted and reference GAs was −1.34 days, with Bland-Altman limits of −21.2 to 18.4 days. As a secondary outcome, the new test achieved 66.6% (95% CI 62.9%-70.1%) agreement with the reference GA within an error of 1 week. This agreement was similar to that of comparator-LMP-GAs (64.1%, 95% CI 60.7%-67.5%). The discrimination between preterm and term newborns via the device had a similar area under the receiver operating characteristic curve (0.970, 95% CI 0.959-0.981) compared with that for comparator-LMP-GAs (0.957, 95% CI 0.941-0.974). In newborns with absent or unreliable LMPs (n=451), the intent-to-discriminate analysis showed correct preterm versus term classifications with the new test, which achieved an accuracy of 89.6% (95% CI 86.4%-92.2%), while the accuracy for comparator-LMP-GA was 69.6% (95% CI 65.3%-73.7%). Conclusions The assessment of newborn’s skin maturity (adjusted by learning models) promises accurate pregnancy dating at birth, even without the antenatal ultrasound reference. Thus, the novel device could add value to the set of clinical parameters that direct the delivery of neonatal care in birth scenarios where GA is unknown or unreliable. International Registered Report Identifier (IRRID) RR2-10.1136/bmjopen-2018-027442

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.

ResumoO presente estudo avaliou a incidência de hipercalemia (potássio > 6mEq/l) em RNPs com peso < 1250 gramas e idade gestacional < 32 semanas nas primeiras 72 horas de vida, nascidos no Hospital de Clínicas de Porto Alegre, no período de 1 ano. A incidência de hipercalemia foi de 38,5% (potássio > 6 mEq/l) e de 15,4% com níveis de potássio passíveis de arritmias cardíacas (KP > 6,7 mEq/l).A população foi dividida em 2 grupos: grupo KN com potássio < 6mEq/l (16 casos) e grupo KE com potássio > 6 mEq/l (10 casos). A conduta no controle hidroeletrolítico e na manutenção do ambiente térmico neutro foi a mesma nos 2 grupos. Nenhum dos grupos recebeu potássio nas primeiras 36 horas de vida.O grupo KE apresentou níveis de potássio mais elevados durante todo o estudo. As médias dos pesos de nascimento dos grupos não diferiram significativamente (KN = 963 gr; KE = 987 gr). O grupo KN apresentou idade gestacional (29,3 semanas X 30,8 semanas) e índice de Apgar no primeiro minuto (3,18 X 5,7) significativamente menores (p = 0,004 e p = 0,015 respectivamente). Não houve diferença significativa entre os dois grupos em relação a hemorragia intraventricular, acidose, doença da membrana hialina, níveis de insulina, glicemia, índice glicemia/ insulina, taxa de filtração glomerular, diurese, potássio urinário, excreção fracionada de sódio, excreção fracionada de potássio e índice tubular de aldosterona. O nível de aldosterona foi significativamente maior no grupo KE com 24 horas de vida (212,8 ng/dl X 110,2 ng/dl, p=0,029). Sugere-se que nenhum dos fatores estudados é responsável pela hipercalemia não oligúrica do recém-nascido de muito baixo peso, salientando-se, entretanto, a importância de controlar os níveis de potássio sérico nesses recém-nascidos.J. pediatr. (Rio J.). 1996; 72(3):143-150: hipercalemia, recém-nascido prematuro, aldosterona, função renal. AbstractThe present study evaluated the incidence of hyperkalemia in premature babies born at the Hospital de Clínicas de Porto Alegre (birthweight < 1250 grams and gestational age < 32 weeks) during the first 72 hours of life in a one year period. The incidence of hyperkalemia was of 38.5% (potassium levels >6 mEq/l) and 15.4% with potassium levels subject to cardiac arrhythmia (> 6.7 mEq/l).The population was divided into two groups: group KN with potassium < 6 mEq/l (n=16) and group KE with potassium > 6 mEq/l (n=10). The hydroelectrolyte management and maintenance of neutral thermal environment was the same for both groups. Neither group received potassium in the first 36 hours of life.The KE group presented higher potassium levels during all the study. The mean birthweights of the groups were similar (KN = 963 gr; KE = 987 gr). The KN group presented a mean gestational age (29.3 weeks x 30.8 weeks) and Apgar Score in the first minute of life (3.18 x 5.7) significantly lower (p = 0.004 and p = 0,015 respectively) than the KE group. There were no significant differences between both groups in relation to the intraventricular hemorrhage, acidosis, hialine membrane disea...

Background and aims:Retinopathy of prematurity (ROP) occurs when abnormal blood vessels grow and spread throughout the retina in immature retina. The disease is one of the main causes of childhood blindness in the world. Risk factors include low birth weight (VLBW), prolonged oxygen therapy, blood transfusions, use of surfactant, septicemia 1,2,3,4 . The aim of this study was to evaluate the incidence of ROP, associated risk factors, in neonates with birth weight ≤1,500 grams and / or gestational age ≤32 weeks (VLBW) in a neonatal intensive care unit (NICU) at the University Hospital in Canoas. MethodsRetrospective study of infants admitted in NICU during two years (2015)(2016). Inclusion criteria was all the VLBW discharged from NICU in the study period.The eye examination was carried out on the 28th day of life. In cases where ROP was diagnosed, they were followed weekly, by the same pediatric ophthalmologist . The analysis technique included pupil dilation with phenylephrine 2.5% + tropicamide 0.5%, one hour before examination. it was used anesthetic eyedrops of proximetacaine and carried out retinal mapping in 360 º with lens of 28 diopters, by means of indirect ophthalmoscopy. Quantitative variables were described by mean and standard deviation or interquartile range and median. Qualitative variables were described by absolute and relative frequencies. To compare means, the t-student test was applied. In asymmetry, the Mann-Whitney test was used. In the comparison of proportions, Pearson's chi-square or Fisher's exact tests were applied. For control of confounding factors, the Poisson Regression analysis was applied. To determine the best cutoff point for ROP, considering the time of mechanical ventilation and gestational age, the Receiver Operating Characteristic curve (ROC) was applied prioritizing the sensitivity of these variables. The level of significance was 5%. The SPSS software version 21.0 was used. The study was approved by the research ethics committee of the Lutheran University of Brazil, under protocol number 2008-546H.

A multicenter clinical trial evaluated the accuracy of a novel device to detect preterm newborns. A portable multiband reflectance photometric device assessed 781 newborns’ skin maturity and used machine learning models to predict reference gestational age, adjusting it to birth weight and antenatal corticosteroid therapy exposure. The day difference between the reference and the test had a median of -1.4 (IQR: -2.1). Using established methods such as comparator ultrasound and last menstrual period (LMP), the medians were 0 (IQR: 4) and 0.01 (IQR: 4), respectively. For prematurity discrimination, the area under the receiver operating characteristic curve (AUROC) was 0.986 (95% CI: 0.977 to 0.994). In newborns with absent or unreliable LMP, the intent-to-discriminate analysis showed that the test generated correct classifications 95.8% of the time. The assessment of the newborn's skin maturity adjusted by learning models promises accurate pregnancy dating at birth without the use of antenatal ultrasound reference.