Newborn Skin Maturity Medical Device Validation for Gestational Age Prediction: Clinical Trial.

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.

Protective measures feasibility for infants of low income SARS-CoV-2 positive breastfeeding mothers: a prospective multicenter cohort study.

AIM: The aim was to evaluate the feasibility of protective measures for infants of low-income SARS-CoV-2 positive breastfeeding mothers. BACKGROUND: Breastfeeding mothers with SARS-CoV-2 positive should avoid exposing the infant through protective measures (PM), but it could be challenging in a low-income population. METHODS: A prospective, multicenter study was conducted between July and October 2020 (BRACOVID). The participants were recruited at birth and interviewed through a structured questionnaire at seven and 14 days in the home environment. The feasibility of PM during breastfeeding at home was defined by guidelines recommendations (mask using, handwashing, and distancing from newborn when not breastfeeding). Three groups according to the feasibility of guidelines: complete guidelines feasibility (CG): all PM; partial guidelines feasibility (PG): at least one PM feasible; no guidelines (NG): infeasibility to all of PM. Flu-like neonatal symptoms, mothers' breastfeeding practices. We evaluated the association between PM feasibility and socioeconomic factors. RESULTS: 117 infected mothers from 17 Brazilian hospitals were enrolled. 47 (40%) mothers followed all recommendations, 14 (11.9%) could not practice at least one recommendation, and 50 (42.7%) did not execute any of them. The breastfeeding rate was 98%. Factors associated with infeasibility were monthly family income < 92.7 dollars/person, high housing density (>1 inhabitant/room), teenage mothers, responsive feeding, and poor schooling. Regarding infants' flu-like symptoms, 5% presented symptoms at fourteen days (NG group). CONCLUSION: The guidelines were not applied to infants of SARs-CoV-positive mothers in 54.6% of the dyads since the recommendations were unviable in their environments. During pandemics, we should look for feasible and effective guidelines to protect neonates from low-income populations. IMPLICATIONS FOR NURSING MANAGEMENT: Poor socioeconomic conditions lead to the unfeasibility of protective measures for infants of low-income SARS-CoV-2 positive breastfeeding mothers during the isolation period in the pandemics. The orientations and the support provided to dyad should consider the socioeconomic factors to guide feasible measures in the home environment and promote adequate protections; only an individual approach will allow a safe environment for low-income infants.

Factors associated with red blood cell transfusions in very-low-birth-weight preterm infants in Brazilian neonatal units.

BACKGROUND: Preterm infants in neonatal intensive care units frequently receive red blood cells (RBC) transfusions due to the anemia of prematurity. A number of variables related to gestational age, severity of illness and transfusion practices adopted in the neonatal unit where the neonate was born may contribute to the prescription of RBC transfusions. This study aimed to analyse the frequency and factors associated with RBC transfusions in very-low-birth-weight preterm infants. METHODS: A prospective cohort of 4283 preterm infants (gestational age: 29.9 ± 2.9 weeks; birth weight: 1084 ± 275 g) carried out at 16 university hospitals in Brazil between January 2009 and December 2011 was analysed. Factors associated with RBC transfusions were evaluated using univariate and multiple logistic regression analysis. RESULTS: A total of 2208 (51.6%) infants received RBC transfusions (variation per neonatal unit: 34.1% to 66.4%). RBC transfusions were significantly associated with gestational age (OR: -1.098; 95%CI: -1.12 to -1.04), SNAPPE II score (1.01; 1.00-1.02), apnea (1.69; 1.34-2.14), pulmonary hemorrhage (2.65; 1.74-4.031), need for oxygen at 28 days of life (1.56; 1.17-2.08), clinical sepsis (3.22; 2.55-4.05), necrotising enterocolitis (3.80; 2.26-6.41), grades III/IV intraventricular hemorrhage (1.64; 1.05-2.58), mechanical ventilation (2.27; 1.74-2.97), use of umbilical catheter (1.86; 1.35-2.57), parenteral nutrition (2.06; 1.27-3.33), >60 days of hospitalization (5.29; 4.02-6.95) and the neonatal unit where the neonate was born. CONCLUSIONS: The frequency of RBC transfusions varied among neonatal intensive care units. Even after adjusting for adverse health conditions and therapeutic interventions, the neonatal unit continued to influence transfusion practices in very-low birth-weight infants.

Renal deficit and associated factors in children born with low birth weight.

INTRODUCTION: Kidney problems may be due to low birth weight alone or may occur in association with other conditions. The objective this study was to evaluate the association between maternal and birth characteristics, anthropometric measurements, and kidney function deficit in low birth weight infants. METHODS: Cross-sectional study with children who were born weighing < 2500 grams and were under outpatient follow-up. Maternal factors investigated were prenatal care and presence of hypertension, diabetes, and infection during pregnancy. The children's variables were sex, gestational age, birth weight, Apgar score, use of nephrotoxic medications, age, body weight at the time of evaluation, height, and serum creatinine and cystatin C dosages. The glomerular filtration rate (GFR) was estimated with the combined Zapittelli equation. Multivariate logistic regression model was used for identification of associated factors, with renal function deficit (GFR < 60 mL/min/1.73 m2) as the dependent variable. RESULTS: Of the 154 children evaluated, 34.42% had kidney function deficit. Most of them had a gestational age > 32 weeks (56.6%), a mean birth weight of 1439.7 grams, and mean estimated GFR of 46.9 ± 9.3 mL/min/1.73 m2. There was a significant association of GFR < 60 mL/min/1.73 m2 with children's current weight and use of nephrotoxic drugs. DISCUSSION: Children born with low birth weight had a high prevalence of kidney function deficit and current normal weight was a protective factor while the use of nephrotoxic drugs during perinatal period increased the chance of kidney deficit. These findings reinforce the need to evaluate the kidney function in these children, especially those who use nephrotoxic drugs.

Probable vertical transmission identified within six hours of life.

We present the case of 33 weeks + weeks pregnant patient (G1P0), with proven COVID-19 infection by RT-PCR and, at admission, she presented with a dry cough and "tiredness when talking,". Chest computed tomography was performed, which showed the presence of attenuations with ground glass opacification and bilateral consolidations. She then had a cesarean section because of maternal respiratory decompensation. She was transferred to the ICU of the same hospital with an O2 catheter. The newborn was transferred to the neonatal ICU of the same hospital in ambient air and maintained in respiratory and contact isolation. RT-PCR was collected for SARS-COV-2 at 6 h of life, which was positive. Faced with the knowledge gap on vertical transmission, RT-PCR for SARS-COV-2 at 6 h of life gives cause for concern, thus representing the possibility of vertical transmission by SARS-COV-2, although additional investigations are required.

Renal deficit and associated factors in children born with low birth weight / Déficit renal e fatores associados em crianças nascidas com baixo peso

ABSTRACT Introduction: Kidney problems may be due to low birth weight alone or may occur in association with other conditions. The objective this study was to evaluate the association between maternal and birth characteristics, anthropometric measurements, and kidney function deficit in low birth weight infants. Methods: Cross-sectional study with children who were born weighing < 2500 grams and were under outpatient follow-up. Maternal factors investigated were prenatal care and presence of hypertension, diabetes, and infection during pregnancy. The children's variables were sex, gestational age, birth weight, Apgar score, use of nephrotoxic medications, age, body weight at the time of evaluation, height, and serum creatinine and cystatin C dosages. The glomerular filtration rate (GFR) was estimated with the combined Zapittelli equation. Multivariate logistic regression model was used for identification of associated factors, with renal function deficit (GFR < 60 mL/min/1.73 m2) as the dependent variable. Results: Of the 154 children evaluated, 34.42% had kidney function deficit. Most of them had a gestational age > 32 weeks (56.6%), a mean birth weight of 1439.7 grams, and mean estimated GFR of 46.9 ± 9.3 mL/min/1.73 m2. There was a significant association of GFR < 60 mL/min/1.73 m2 with children's current weight and use of nephrotoxic drugs. Discussion: Children born with low birth weight had a high prevalence of kidney function deficit and current normal weight was a protective factor while the use of nephrotoxic drugs during perinatal period increased the chance of kidney deficit. These findings reinforce the need to evaluate the kidney function in these children, especially those who use nephrotoxic drugs.

RESUMO Introdução: Problemas renais podem ser devido apenas ao baixo peso ao nascer ou podem ocorrer em associação com outras condições. O objetivo deste estudo foi avaliar a associação entre características maternas e de nascimento, medidas antropométricas e déficit da função renal em bebês de baixo peso ao nascer. Métodos: Estudo transversal com crianças que nasceram com peso < 2500 gramas e estavam sob acompanhamento ambulatorial. Os fatores maternos investigados foram cuidados pré-natal e presença de hipertensão, diabetes e infecção durante a gravidez. As variáveis das crianças foram sexo, idade gestacional, peso ao nascer, índice Apgar, uso de medicamentos nefrotóxicos, idade, peso corporal no momento da avaliação, altura e dosagens séricas de creatinina e cistatina C. A taxa de filtração glomerular (TFG) foi estimada com a equação combinada de Zapittelli. Utilizou-se um modelo de regressão logística multivariada para identificação de fatores associados, com déficit da função renal (TFG < 60 mL/min/1,73 m2) como variável dependente. Resultados: Das 154 crianças avaliadas, 34,42% apresentaram déficit da função renal. A maioria tinha idade gestacional > 32 semanas (56,6%), peso médio ao nascer de 1439,7 gramas, e TFG média estimada de 46,9 ± 9,3 mL/min/1,73 m2. Houve uma associação significativa da TFG < 60 mL/min/1,73 m2 com o peso atual das crianças e o uso de medicamentos nefrotóxicos. Discussão: Crianças nascidas com baixo peso apresentaram alta prevalência de déficit da função renal e o peso atual normal foi um fator de proteção, enquanto o uso de medicamentos nefrotóxicos durante o período perinatal aumentou a chance de déficit renal. Estes achados reforçam a necessidade de avaliar a função renal destas crianças, especialmente aquelas que usam medicamentos nefrotóxicos.

T-piece versus self-inflating bag ventilation in preterm neonates at birth.

OBJECTIVE: To verify whether the use of the T-piece resuscitator compared with the self-inflating bag in preterm infants ventilated at birth modifies survival to hospital discharge without major morbidities. DESIGN: Pragmatic prospective cohort study. SETTING: 20 Brazilian university hospitals of Brazilian Network on Neonatal Research. Patients were 1962 inborn infants in 2014-2015 ventilated at birth with 23-33' weeks gestation and birth weight 400-1499 g without malformations. Patients transferred until the 27th day after birth were excluded. INTERVENTIONS: Positive pressure ventilation at birth with T-piece resuscitator or self-inflating bag without positive end expiratory pressure valve. Intervention with ventilation followed the Brazilian Society of Pediatrics guidelines. The choice of the equipment was at the neonatologist's discretion in each delivery. The main outcome measures were survival to hospital discharge without bronchopulmonary dysplasia, severe peri-intraventricular haemorrhage and periventricular leucomalacia. Logistic regression adjusted for confounding variables was applied for main outcome. RESULTS: 1456 (74%) were only ventilated with T-piece resuscitator and 506 (26%) with the self-inflating bag. The characteristics of those ventilated with T-Piece resuscitator versus self-inflating bag were birth weight 969 ± 277 vs 941 ± 279 g, gestational age 28.2±2.5 vs 27.8±2.7 weeks and survival to hospital discharge without major morbidities 47% vs 35%. Logistic regression adjusted for maternal characteristics, obstetric and neonatal morbidities showed that the T-piece resuscitator increased the chance of survival to hospital discharge without major morbidities (OR=1.38; 95% CI 1.06 to 1.80; Hosmer-Lemeshow goodness of fit: 0.695). CONCLUSION: This study is the first that highlights the effectiveness of T-piece resuscitator ventilation in improving relevant outcomes in preterm neonates.

Probable vertical transmission identified within six hours of life

SUMMARY We present the case of 33 weeks + weeks pregnant patient (G1P0), with proven COVID-19 infection by RT-PCR and, at admission, she presented with a dry cough and "tiredness when talking,". Chest computed tomography was performed, which showed the presence of attenuations with ground glass opacification and bilateral consolidations. She then had a cesarean section because of maternal respiratory decompensation. She was transferred to the ICU of the same hospital with an O2 catheter. The newborn was transferred to the neonatal ICU of the same hospital in ambient air and maintained in respiratory and contact isolation. RT-PCR was collected for SARS-COV-2 at 6 h of life, which was positive. Faced with the knowledge gap on vertical transmission, RT-PCR for SARS-COV-2 at 6 h of life gives cause for concern, thus representing the possibility of vertical transmission by SARS-COV-2, although additional investigations are required.

RESUMO Apresentamos o caso de uma paciente grávida de 33 semanas + (G1P0), com infecção de COVID-19 comprovada por RT-PCR que, na admissão, apresentava tosse seca e "cansaço ao falar". Foi realizada tomografia computadorizada do tórax, que mostrou a presença de atenuações com opacidade em vidro fosco e consolidações bilaterais. Ela então passou por uma cesariana devido a descompensação respiratória materna. Em seguida, foi transferida para a UTI do mesmo hospital com um cateter de O2. O recém-nascido foi transferido para a UTI neonatal do mesmo hospital, em ar ambiente, e mantido em isolamento respiratório e de contato. Material para o RT-PCR para SARS-COV-2 foi coletado às 6h de vida, e o resultado do teste foi positivo. Perante a lacuna de conhecimento sobre a transmissão vertical, o resultado positivo do RT-PCR para SARS-COV-2 às 6h de vida é motivo de preocupação, pois representa uma possível transmissão vertical do SARS-COV-2, embora investigações adicionais sejam necessárias.

Acalvaria primária: relato de caso / Primary acalvaria: a case report

Acalvaria é uma malformação congênita rara de patogênese desconhecida, na qual os ossos da abóbada craniana, a dura-máter e a musculatura associada estão ausentes, mas o sistema nervoso central costuma estar preservado. A teoria fisiopatogênica mais aceita sugere um defeito pós-neurulação, com disposição normal do ectoderma embrionário. O objetivo deste relato é descrever os achados de imagem neonatais da acalvaria primária.

Acalvaria is a rare congenital malformation of unknown pathogenesis characterized by the absence of the flat bones of the cranial vault, dura mater and associated muscles, while the central nervous system is usually preserved. The most accepted physiopathogenic theory suggests the presence of a postneurulation defect with normal placement the embryonic ectoderm. The present report describes neonatal imaging findings of primary acalvaria.