RESUMEN
OBJECTIVE: It is currently unknown whether adjunctive azithromycin prophylaxis at the time of non-elective cesarean has differential effects on neonatal outcomes in the context of prematurity. The objective of this study was to compare whether neonatal outcomes differ in term and preterm infants exposed to adjunctive azithromycin prophylaxis before non-elective cesarean delivery. STUDY DESIGN: A planned secondary analysis of a multi-center randomized controlled trial that enrolled women with singleton pregnancies ≥24 weeks gestation undergoing non-elective cesarean delivery (during labor or ≥4 h after membrane rupture). Women received standard antibiotic prophylaxis and were randomized to either adjunctive azithromycin (500 mg) or placebo. The primary composite outcome was neonatal death, suspected or confirmed neonatal sepsis, and serious neonatal morbidities (NEC, PVL, IVH, BPD). Secondary outcomes included NICU admission, neonatal readmission, culture positive infections and prevalence of resistant organisms. Odds ratios (OR) for the effect of azithromycin versus placebo were compared between gestational age strata (preterm [less than 37 weeks] versus term [37 weeks or greater]). Tests of interaction examined homogeneity of treatment effect with gestational age. RESULTS: The analysis includes 2,013 infants, 226 preterm (11.2%) and 1,787 term. Mean gestational ages were 34 and 39.5 weeks, respectively. Within term and preterm strata, maternal and delivery characteristics were similar between the azithromycin and placebo groups. There was no difference in the odds of composite neonatal outcome between those exposed to azithromycin versus placebo in preterm neonates (OR 0.82, 95% CI 0.48-1.41) and in term neonates (OR 1.06, 95% CI 0.77-1.46), with no difference between gestational age strata (p = 0.42). Analysis of secondary outcomes also revealed no differences in treatment effects within or between gestational age strata. CONCLUSION: Exposure to adjunctive azithromycin antibiotic prophylaxis for non-elective cesarean delivery does not increase neonatal morbidity or mortality in term or preterm infants. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov, NCT01235546.
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Antibacterianos , Profilaxis Antibiótica , Azitromicina , Cesárea , Recien Nacido Prematuro , Humanos , Azitromicina/uso terapéutico , Azitromicina/administración & dosificación , Femenino , Profilaxis Antibiótica/métodos , Recién Nacido , Embarazo , Cesárea/estadística & datos numéricos , Antibacterianos/uso terapéutico , Antibacterianos/administración & dosificación , Adulto , Edad Gestacional , Nacimiento a Término , Enfermedades del Recién Nacido/prevención & control , Enfermedades del Recién Nacido/epidemiologíaRESUMEN
BACKGROUND: Neonatal hypoglycaemia is the most common metabolic disorder in infants, and may be influenced by maternal glycaemic control. This systematic review evaluated the effect of intrapartum maternal glycaemic control on neonatal hypoglycaemia. METHODS: We included randomised controlled trials (RCTs), quasi-RCTs, non-randomised studies of interventions, and cohort or case-control studies that examined interventions affecting intrapartum maternal glycaemic control compared to no or less stringent control. We searched four databases and three trial registries to November 2023. Quality assessments used Cochrane Risk of Bias 1 or the Effective Public Health Practice Project Quality Assessment Tool. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Meta-analysis was performed using random-effects models analysed separately for women with or without diabetes. The review was registered prospectively on PROSPERO (CRD42022364876). RESULTS: We included 46 studies of women with diabetes and five studies of women without diabetes: one RCT, 32 cohort and 18 case-control studies (11,273 participants). For women with diabetes, the RCT showed little to no difference in the incidence of neonatal hypoglycaemia between tight versus less tight intrapartum glycaemic control groups (76 infants, RR 1.00 (0.45, 2.24), p = 1.00, low certainty evidence). However, 11 cohort studies showed tight intrapartum glycaemic control may reduce neonatal hypoglycaemia (6,152 infants, OR 0.44 (0.31, 0.63), p < 0.00001, I2 = 58%, very low certainty evidence). For women without diabetes, there was insufficient evidence to determine the effect of tight intrapartum glycaemic control on neonatal hypoglycaemia. CONCLUSIONS: Very uncertain evidence suggests that tight intrapartum glycaemic control may reduce neonatal hypoglycaemia in infants of women with diabetes. High-quality RCTs are required.
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Control Glucémico , Hipoglucemia , Humanos , Hipoglucemia/prevención & control , Embarazo , Femenino , Recién Nacido , Control Glucémico/métodos , Embarazo en Diabéticas/prevención & control , Glucemia/análisis , Diabetes Gestacional/prevención & control , Enfermedades del Recién Nacido/prevención & controlRESUMEN
BACKGROUND: Placental management strategies such as umbilical cord milking and delayed cord clamping may provide a range of benefits for the newborn. The aim of this review was to assess the effectiveness of umbilical cord milking and delayed cord clamping for the prevention of neonatal hypoglycaemia. METHODS: Three databases and five clinical trial registries were systematically reviewed to identify randomised controlled trials comparing umbilical cord milking or delayed cord clamping with control in term and preterm infants. The primary outcome was neonatal hypoglycaemia (study defined). Two independent reviewers conducted screening, data extraction and quality assessment. Quality of the included studies was assessed using the Cochrane Risk of Bias tool (RoB-2). Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Meta-analysis using a random effect model was done using Review Manager 5.4. The review was registered prospectively on PROSPERO (CRD42022356553). RESULTS: Data from 71 studies and 14 268 infants were included in this review; 22 (2 537 infants) compared umbilical cord milking with control, and 50 studies (11 731 infants) compared delayed with early cord clamping. For umbilical cord milking there were no data on neonatal hypoglycaemia, and no differences between groups for any of the secondary outcomes. We found no evidence that delayed cord clamping reduced the incidence of hypoglycaemia (6 studies, 444 infants, RR = 0.87, CI: 0.58 to 1.30, p = 0.49, I2 = 0%). Delayed cord clamping was associated with a 27% reduction in neonatal mortality (15 studies, 3 041 infants, RR = 0.73, CI: 0.55 to 0.98, p = 0.03, I2 = 0%). We found no evidence for the effect of delayed cord clamping for any of the other outcomes. The certainty of evidence was low for all outcomes. CONCLUSION: We found no data for the effectiveness of umbilical cord milking on neonatal hypoglycaemia, and no evidence that delayed cord clamping reduced the incidence of hypoglycaemia, but the certainty of the evidence was low.
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Hipoglucemia , Clampeo del Cordón Umbilical , Cordón Umbilical , Humanos , Hipoglucemia/prevención & control , Recién Nacido , Cordón Umbilical/cirugía , Femenino , Embarazo , Clampeo del Cordón Umbilical/métodos , Factores de Tiempo , Ensayos Clínicos Controlados Aleatorios como Asunto , Enfermedades del Recién Nacido/prevención & control , ConstricciónRESUMEN
OBJECTIVE: To evaluate the efficacy of antenatal corticosteroids in reducing neonatal respiratory complications when administered to those at risk of preterm delivery between 34 and 36 6/7 weeks of gestation. METHODS: This was a single-center, triple-blind, randomized, placebo-controlled trial in southern India enrolling pregnant participants at risk of preterm delivery between 34 and 36 6/7 weeks of gestation. Computer-generated block randomization was used with participants randomized to either one course of intramuscular betamethasone or placebo. The primary outcome was a composite of treatment for respiratory distress in the neonate, defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life. Neonatal secondary outcomes were transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, hypoglycemia, stillbirth, and early neonatal death; maternal secondary outcomes were chorioamnionitis, postpartum hemorrhage, puerperal fever, and length of hospitalization. All analyses were based on intention to treat. A sample size of 1,200 was planned with 80% power to detect a 30% reduction in rates of respiratory distress. After a planned interim analysis, enrollment was stopped for futility. RESULTS: From March 2020 to August 2022, 847 participants were recruited, with 423 participants randomized to betamethasone and 424 participants randomized to placebo. There were 22 individuals lost to follow-up. There was no statistically significant difference in the primary outcome (betamethasone 4.9% vs placebo 4.8%, relative risk 1.03, 95% CI, 0.57-1.84, number needed to treat 786). There were no statistically significant differences in secondary neonatal or maternal outcomes. CONCLUSION: Betamethasone administered in the late-preterm period to those at risk for preterm delivery did not reduce the need for treatment of neonatal respiratory distress. CLINICAL TRIAL REGISTRATION: Clinical Trials Registry of India, CTRI/2019/09/021321.
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Enfermedades del Recién Nacido , Nacimiento Prematuro , Síndrome de Dificultad Respiratoria del Recién Nacido , Síndrome de Dificultad Respiratoria , Recién Nacido , Embarazo , Femenino , Humanos , Nacimiento Prematuro/prevención & control , Betametasona/uso terapéutico , Corticoesteroides/uso terapéutico , Glucocorticoides/uso terapéutico , Síndrome de Dificultad Respiratoria del Recién Nacido/prevención & control , Enfermedades del Recién Nacido/prevención & controlRESUMEN
BACKGROUND: Poor feeding, among other factors, predisposes neonates to hypoglycaemia. Early feeding is widely recommended to prevent hypoglycaemia in those at risk, but the effectiveness of this is uncertain. This review aimed to summarise and analyse the evidence on the effectiveness of early feeding for prevention of neonatal hypoglycaemia. METHODS: Four databases and three clinical trial registries were searched from inception to May 24, 2023. Published and unpublished randomised controlled trials (RCTs), quasi-RCTs, cluster randomised trials, non-randomised studies of interventions, and observational studies with comparison groups were considered for inclusion with no language or publication date restrictions. We included studies of neonates who were fed early (within 60 min of birth or study defined) versus delayed. Study quality was assessed using the Cochrane Risk of Bias 1 tool or Effective Public Health Practice Project Quality Assessment tool. Certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. RevMan 5.4.1 or R was used to synthesise results in random-effects meta-analyses. This review was registered prospectively with PROSPERO (CRD42022378904). RESULTS: A total of 175,392 participants were included across 19 studies, of which two were RCTs, 14 cohort studies, two cross-sectional studies, and one a case-control study. Most studies (13/19) were conducted in low- or lower-middle-income countries. Early feeding may be associated with reduced neonatal hypoglycaemia (four cohort studies, 744 infants, odds ratio [OR] 0.19 (95% CI: 0.10-0.35), p < 0.00001, I2 = 44%) and slightly reduced duration of initial hospital stay (one cohort study, 1,673 infants, mean difference: -0.20 days [95% CI: -0.31 to -0.09], p = 0.0003), but the evidence is very uncertain. One RCT found early feeding had little or no effect on the risk of neonatal mortality, but three cohort studies found early feeding may be associated with reduced risk (136,468 infants, OR 0.51 [95% CI: 0.37-0.72]; low certainty evidence; p <0.0001; I2 = 54%). CONCLUSION: We found that early feeding may reduce the incidence of neonatal hypoglycaemia, but the evidence is very uncertain. Given its many other benefits, early feeding should continue to be recommended. This review was primarily funded by the Aotearoa Foundation and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health.
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Hipoglucemia , Humanos , Recién Nacido , Hipoglucemia/prevención & control , Factores de Tiempo , Ensayos Clínicos Controlados Aleatorios como Asunto , Enfermedades del Recién Nacido/prevención & controlRESUMEN
BACKGROUND: Neonatal hypoglycemia (NH) is the most prevalent metabolic disorder in neonates and glucose gel in oral solution is a relatively new treatment option for NH. We aimed to determine whether oral glucose gel can prevent NH. METHODS: We conducted an open literature search using PubMed, Embase, Cochrane Library, and Web of Science. We used relative risk as the statistical data, expressed each outcome effect as a 95% confidence interval, and conducted a heterogeneity test. If heterogeneity statistics indicated that I2 was ≥ 50%, the random effects model analysis was used; otherwise, the fixed effects model analysis was conducted, and sensitivity analyses were conducted for all outcomes. RESULTS: In this review, we included a total of 10 studies involving 4801 neonates. Meta-analysis revealed that there were no significant differences between the preventive oral glucose gel group and the control group in terms of blood glucose concentration, glucose concentration 30 minutes after the first breastfeeding, length of stay, Bayley-III composite score, subsequent need for intravenous injection of glucose, 24-hour glucose > 50 mg/dL, separation from mother for treatment of hypoglycemia/admitted to neonatal intensive care unit for hypoglycemia, normoglycemia after 1 to 2 treatments, or normoglycemia after more than 2 treatments, breastfeeding at discharge, delayed feeding, neurosensory impairment, parental satisfaction, developmental delay, and seizure. The subsequent intake was significantly lower in the glucose gel group compared to the control group. INTERPRETATION: The use of oral glucose gel as a preventative measure may not reduce the incidence of NH. In order to assess the efficacy of glucose gel in preventing NH, a more high-quality, large-sample, and rigorously designed randomized controlled trial is required.
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Hipoglucemia , Enfermedades del Recién Nacido , Recién Nacido , Femenino , Humanos , Glucosa/uso terapéutico , Hipoglucemia/prevención & control , Hipoglucemia/tratamiento farmacológico , Administración Oral , Lactancia Materna , Geles/uso terapéutico , Enfermedades del Recién Nacido/prevención & control , Enfermedades del Recién Nacido/tratamiento farmacológicoRESUMEN
Importance: Insulin is recommended for pregnant persons with preexisting type 2 diabetes or diabetes diagnosed early in pregnancy. The addition of metformin to insulin may improve neonatal outcomes. Objective: To estimate the effect of metformin added to insulin for preexisting type 2 or diabetes diagnosed early in pregnancy on a composite adverse neonatal outcome. Design, Setting, and Participants: This randomized clinical trial in 17 US centers enrolled pregnant adults aged 18 to 45 years with preexisting type 2 diabetes or diabetes diagnosed prior to 23 weeks' gestation between April 2019 and November 2021. Each participant was treated with insulin and was assigned to add either metformin or placebo. Follow-up was completed in May 2022. Intervention: Metformin 1000 mg or placebo orally twice per day from enrollment (11 weeks -<23 weeks) through delivery. Main Outcome and Measures: The primary outcome was a composite of neonatal complications including perinatal death, preterm birth, large or small for gestational age, and hyperbilirubinemia requiring phototherapy. Prespecified secondary outcomes included maternal hypoglycemia and neonatal fat mass at birth, and prespecified subgroup analyses by maternal body mass index less than 30 vs 30 or greater and those with preexisting vs diabetes early in pregnancy. Results: Of the 831 participants randomized, 794 took at least 1 dose of the study agent and were included in the primary analysis (397 in the placebo group and 397 in the metformin group). Participants' mean (SD) age was 32.9 (5.6) years; 234 (29%) were Black, and 412 (52%) were Hispanic. The composite adverse neonatal outcome occurred in 280 (71%) of the metformin group and in 292 (74%) of the placebo group (adjusted odds ratio, 0.86 [95% CI 0.63-1.19]). The most commonly occurring events in the primary outcome in both groups were preterm birth, neonatal hypoglycemia, and delivery of a large-for-gestational-age infant. The study was halted at 75% accrual for futility in detecting a significant difference in the primary outcome. Prespecified secondary outcomes and subgroup analyses were similar between groups. Of individual components of the composite adverse neonatal outcome, metformin-exposed neonates had lower odds to be large for gestational age (adjusted odds ratio, 0.63 [95% CI, 0.46-0.86]) when compared with the placebo group. Conclusions and Relevance: Using metformin plus insulin to treat preexisting type 2 or gestational diabetes diagnosed early in pregnancy did not reduce a composite neonatal adverse outcome. The effect of reduction in odds of a large-for-gestational-age infant observed after adding metformin to insulin warrants further investigation. Trial Registration: ClinicalTrials.gov Identifier: NCT02932475.
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Diabetes Mellitus Tipo 2 , Diabetes Gestacional , Hipoglucemiantes , Insulina , Metformina , Adulto , Femenino , Humanos , Recién Nacido , Embarazo , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Gestacional/tratamiento farmacológico , Hipoglucemia/inducido químicamente , Hipoglucemiantes/administración & dosificación , Hipoglucemiantes/efectos adversos , Hipoglucemiantes/uso terapéutico , Enfermedades del Recién Nacido/inducido químicamente , Enfermedades del Recién Nacido/etiología , Enfermedades del Recién Nacido/prevención & control , Insulina/administración & dosificación , Insulina/efectos adversos , Insulina/uso terapéutico , Insulina Regular Humana/uso terapéutico , Metformina/administración & dosificación , Metformina/efectos adversos , Metformina/uso terapéutico , Nacimiento Prematuro/inducido químicamente , Nacimiento Prematuro/epidemiología , Nacimiento Prematuro/etiología , Adolescente , Adulto Joven , Persona de Mediana EdadAsunto(s)
Anticuerpos Antivirales , Enfermedades del Recién Nacido , Infecciones por Virus Sincitial Respiratorio , Virus Sincitial Respiratorio Humano , Humanos , Lactante , Virus Sincitial Respiratorio Humano/efectos de los fármacos , Virus Sincitial Respiratorio Humano/inmunología , Infecciones por Virus Sincitial Respiratorio/tratamiento farmacológico , Infecciones por Virus Sincitial Respiratorio/inmunología , Infecciones por Virus Sincitial Respiratorio/prevención & control , Anticuerpos Antivirales/inmunología , Anticuerpos Antivirales/uso terapéutico , Enfermedades del Recién Nacido/tratamiento farmacológico , Enfermedades del Recién Nacido/inmunología , Enfermedades del Recién Nacido/prevención & control , Vacunas contra Virus Sincitial RespiratorioRESUMEN
Neonatal hypoglycemia affects up to 15% of all newborns. Despite the high prevalence there is no uniform definition of neonatal hypoglycemia, and existing guidelines differ significantly in terms of when and whom to screen for hypoglycemia, and where to set interventional thresholds and treatment goals. In this review, we discuss the difficulties to define hypoglycemia in neonates. Existing knowledge on different strategies to approach this problem will be reviewed with a focus on long-term neurodevelopmental outcome studies and results of interventional trials. Furthermore, we compare existing guidelines on the screening and management of neonatal hypoglycemia. We summarize that evidence-based knowledge about whom to screen, how to screen, and how to manage neonatal hypoglycemia is limited - particularly regarding operational thresholds (single values at which to intervene) and treatment goals (what blood glucose to aim for) to reliably prevent neurodevelopmental sequelae. These research gaps need to be addressed in future studies, systematically comparing different management strategies to progressively optimize the balance between prevention of neurodevelopmental sequelae and the burden of diagnostic or therapeutic procedures. Unfortunately, such studies are exceptionally challenging because they require large numbers of participants to be followed for years, as mild but relevant neurological consequences may not become apparent until mid-childhood or even later. Until there is clear, reproducible evidence on what blood glucose levels may be tolerated without negative impact, the operational threshold needs to include some safety margin to prevent potential long-term neurocognitive impairment from outweighing the short-term burden of hypoglycemia prevention during neonatal period.
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Enfermedades Fetales , Hipoglucemia , Enfermedades del Recién Nacido , Femenino , Recién Nacido , Humanos , Niño , Glucemia , Hipoglucemia/diagnóstico , Hipoglucemia/prevención & control , Hipoglucemia/epidemiología , Enfermedades del Recién Nacido/diagnóstico , Enfermedades del Recién Nacido/prevención & control , Progresión de la EnfermedadRESUMEN
BACKGROUNDS: Due to immaturity of their immune system, passive maternal immunization is essential for newborns during their first months of life. Therefore, in the current context of intense circulation of SARS-CoV-2, identifying factors influencing the transfer ratio (TR) of neutralizing antibodies against SARS-CoV-2 (NAb) appears important. METHODS: Our study nested in the COVIPREG cohort (NCT04355234), included mothers who had a SARS-CoV-2 PCR positive during their pregnancy and their newborns. Maternal and neonatal NAb levels were measured with the automated iFlash system. RESULTS: For the 173 mother-infant pairs included in our study, the median gestational age (GA) at delivery was 39.4 weeks of gestation (WG), and 29.7 WG at maternal SARS-CoV-2 infection. Using a multivariate logistic model, having a NAb TR above 1 was positively associated with a longer delay from maternal positive SARS-CoV-2 PCR to delivery (aOR 1.09, 95% CI: 1.03 - 1.17) and with a later GA at delivery (aOR = 1.58, 95% CI: 1.09 - 2.52). It was negatively associated with being a male newborn (aOR 0.21, 95% CI: 0.07 - 0.59). In 3rd trimester SARS-CoV-2 infected mothers, NAb TR was inferior to VZV, toxoplasmosis, CMV, measle and rubella's TR. However, in 1st or 2nd trimester infected mothers, only measle TR was different from NAb TR. CONCLUSION: Male newborn of mothers infected by SARS-CoV-2 during their pregnancy appear to have less protection against SARS-CoV-2 in their first months of life than female newborns. Measle TR was superior to NAb TR even in case of 1st or 2nd trimester maternal SARS-CoV-2 infection. Future studies are needed to investigate possible differences in transmission of NAb following infection vs vaccination and its impact on TR.
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Anticuerpos Neutralizantes , COVID-19 , Enfermedades del Recién Nacido , Transmisión Vertical de Enfermedad Infecciosa , Intercambio Materno-Fetal , Complicaciones del Embarazo , SARS-CoV-2 , SARS-CoV-2/inmunología , Anticuerpos Neutralizantes/sangre , Anticuerpos Neutralizantes/inmunología , Intercambio Materno-Fetal/inmunología , Edad Gestacional , Humanos , Masculino , Femenino , COVID-19/sangre , COVID-19/inmunología , COVID-19/prevención & control , Parto Obstétrico , Anticuerpos Antivirales/sangre , Anticuerpos Antivirales/inmunología , Embarazo , Recién Nacido , Caracteres Sexuales , Vacunas contra la COVID-19 , Vacunación , Complicaciones del Embarazo/sangre , Complicaciones del Embarazo/inmunología , Enfermedades del Recién Nacido/inmunología , Enfermedades del Recién Nacido/prevención & control , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Paris , AdultoAsunto(s)
Anticuerpos Monoclonales Humanizados , Antivirales , Enfermedades del Recién Nacido , Recien Nacido Prematuro , Infecciones por Virus Sincitial Respiratorio , Humanos , Lactante , Recién Nacido , Anticuerpos Monoclonales Humanizados/uso terapéutico , Antivirales/uso terapéutico , Hospitalización , Palivizumab , Infecciones por Virus Sincitial Respiratorio/prevención & control , Infecciones por Virus Sincitial Respiratorio/tratamiento farmacológico , Nacimiento a Término , Enfermedades del Recién Nacido/tratamiento farmacológico , Enfermedades del Recién Nacido/prevención & controlRESUMEN
BACKGROUND: Group B Streptococcus (GBS) is the leading cause of neonatal morbidity and mortality in developed countries. This study aims primarily to estimate the prevalence of maternal GBS positivity and secondarily to evaluate the compliance and the effectiveness of the current GBS prevention protocol. METHODS: This retrospective study has considered 27382 single pregnancies carried to delivery between 2001 and 2014 at our Obstetrics and Gynecology clinic. All women carrying a singleton pregnancy in the considered period were eligible to be included in this study. RESULTS: The GBS swab was positive in 17.66% of cases, negative in 51.93%, and unknown in 30.41%. Data collected revealed that out of the total of GBS-positive women, 3362 were treated with antibiotic prophylaxis, and 1331 were not. There were no differences between cases admitted to Neonatal Intensive Care Unit and perinatal deaths between treated and non-treated GBS-positive pregnancies. Moreover, the data showed that 74.62% of patients between 34 and 37 weeks of gestation at the time of delivery were treated with antibiotic prophylaxis unnecessarily, and 25.38% of patients >37 weeks of gestation whose GBS status at delivery was unknown would have required intrapartum antibiotic prophylaxis. The only risk factor for chorioamnionitis among GBS-positive women in multivariate logistic regression analysis was an early gestational age (OR 0.61; 95% CI: 0.56-0.66; P<0.05). CONCLUSIONS: GBS prevalence was found to be 17.66%, and prophylaxis in colonized patients was carried out correctly according to our internal procedure allowing a low incidence of adverse outcomes. Finally, the only risk factor associated with chorioamnionitis in GBS patients was early gestational age at delivery.
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Corioamnionitis , Enfermedades del Recién Nacido , Complicaciones Infecciosas del Embarazo , Infecciones Estreptocócicas , Embarazo , Recién Nacido , Humanos , Femenino , Complicaciones Infecciosas del Embarazo/tratamiento farmacológico , Complicaciones Infecciosas del Embarazo/epidemiología , Complicaciones Infecciosas del Embarazo/prevención & control , Estudios Retrospectivos , Infecciones Estreptocócicas/tratamiento farmacológico , Infecciones Estreptocócicas/epidemiología , Infecciones Estreptocócicas/prevención & control , Transmisión Vertical de Enfermedad Infecciosa/prevención & control , Streptococcus agalactiae , Enfermedades del Recién Nacido/epidemiología , Enfermedades del Recién Nacido/prevención & controlRESUMEN
Sitio web de la institución Fundación de Ayuda de Recien Nacido con Problemas Neurológicos (NeNe) ubicada en España y contiene cursos, publicaciones, podcasts y otros con la misión de la mejora en la atención y el diagnóstico precoz de los problemas neurológicos del recién nacido permitirá disminuir su impacto médico, familiar y social, contribuyendo a reducir las tasas de discapacidad por problemas neurológicos y mejorar los niveles de calidad de vida de los niños afectados y de su entorno.
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Enfermedades del Sistema Nervioso/prevención & control , Enfermedades del Recién Nacido/prevención & controlAsunto(s)
Enfermedades del Recién Nacido , Complicaciones Infecciosas del Embarazo , Infecciones Estreptocócicas , Femenino , Humanos , Recién Nacido , Enfermedades del Recién Nacido/diagnóstico , Enfermedades del Recién Nacido/prevención & control , Embarazo , Infecciones Estreptocócicas/tratamiento farmacológico , Infecciones Estreptocócicas/epidemiología , Infecciones Estreptocócicas/prevención & control , Streptococcus agalactiaeAsunto(s)
Tamizaje Neonatal/historia , Tamizaje Neonatal/métodos , Tamizaje Neonatal/organización & administración , Enfermedades del Recién Nacido/diagnóstico , Enfermedades del Recién Nacido/prevención & control , Fenilcetonurias/diagnóstico , Argentina , Hiperplasia Suprarrenal Congénita/diagnóstico , Hipotiroidismo Congénito/diagnóstico , Fibrosis Quística/diagnóstico , Galactosemias/diagnósticoRESUMEN
Multiparameter continuous physiological monitoring (MCPM) technologies are critical in the clinical management of high-risk neonates; yet, these technologies are frequently unavailable in many African healthcare facilities. We conducted a prospective clinical feasibility study of EarlySense's novel under-mattress MCPM technology in neonates at Pumwani Maternity Hospital in Nairobi, Kenya. To assess feasibility, we compared the performance of EarlySense's technology to Masimo's Rad-97 pulse CO-oximeter with capnography technology for heart rate (HR) and respiratory rate (RR) measurements using up-time, clinical event detection performance, and accuracy. Between September 15 and December 15, 2020, we collected and analyzed 470 hours of EarlySense data from 109 enrolled neonates. EarlySense's technology's up-time per neonate was 2.9 (range 0.8, 5.3) hours for HR and 2.1 (range 0.9, 4.0) hours for RR. The difference compared to the reference was a median of 0.6 (range 0.1, 3.1) hours for HR and 0.8 (range 0.1, 2.9) hours for RR. EarlySense's technology identified high HR and RR events with high sensitivity (HR 81%; RR 83%) and specificity (HR 99%; RR 83%), but was less sensitive for low HR and RR (HR 0%; RR 14%) although maintained specificity (HR 100%; RR 95%). There was a greater number of false negative and false positive RR events than false negative and false positive HR events. The normalized spread of limits of agreement was 9.6% for HR and 28.6% for RR, which met the a priori-identified limit of 30%. EarlySense's MCPM technology was clinically feasible as demonstrated by high percentage of up-time, strong clinical event detection performance, and agreement of HR and RR measurements compared to the reference technology. Studies in critically ill neonates, assessing barriers and facilitators to adoption, and costing analyses will be key to the technology's development and potential uptake and scale-up.
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Maternidades , Hospitales Públicos , Enfermedades del Recién Nacido/diagnóstico , Enfermedades del Recién Nacido/prevención & control , Monitoreo Fisiológico/métodos , Reacciones Falso Negativas , Reacciones Falso Positivas , Estudios de Factibilidad , Femenino , Frecuencia Cardíaca , Humanos , Recién Nacido , Kenia , Límite de Detección , Embarazo , Estudios Prospectivos , Frecuencia Respiratoria , RiesgoRESUMEN
BACKGROUND: Management of high-risk newborns should involve the use of standardized protocols and training, continuous and specialized brain monitoring with electroencephalography (EEG), amplitude integrated EEG, Near Infrared Spectroscopy, and neuroimaging. Brazil is a large country with disparities in health care assessment and some neonatal intensive care units (NICUs) are not well structured with trained personnel able to provide adequate neurocritical care. To reduce this existing gap, an advanced telemedicine model of neurocritical care called Protecting Brains and Saving Futures (PBSF) Guidelines was developed and implemented in a group of Brazilian NICUs. METHODS: A prospective, multicenter, and observational study will be conducted in all 20 Brazilian NICUs using the PBSF Guidelines as standard-of-care. All infants treated accordingly to the guidelines during Dec 2021 to Nov 2024 will be eligible. Ethical approval was obtained from participating centers. The primary objective is to describe adherence to the PBSF Guidelines and clinical outcomes, by center and over a 3-year period. Adherence will be measured by quantification of neuromonitoring, neuroimaging exams, sub-specialties consultation, and clinical case discussions and videoconference meetings. Clinical outcomes of interest are detection of seizures during hospitalization, use of anticonvulsants, inotropes, and fluid resuscitation, death before hospital discharge, length of hospital stay, and referral of patients to specialized follow-up. DISCUSSION: The study will provide evaluation of PBSF Guidelines adherence and its impact on clinical outcomes. Thus, data from this large prospective, multicenter, and observational study will help determine whether neonatal neurocritical care via telemedicine can be effective. Ultimately, it may offer the necessary framework for larger scale implementation and development of research projects using remote neuromonitoring. TRIAL REGISTRATION: NCT03786497, Registered 26 December 2018, https://www.clinicaltrials.gov/ct2/show/NCT03786497?term=protecting+brains+and+saving+futures&draw=2&rank=1.
Asunto(s)
Encéfalo/fisiología , Atención a la Salud/normas , Enfermedades del Recién Nacido/prevención & control , Unidades de Cuidado Intensivo Neonatal/normas , Guías de Práctica Clínica como Asunto/normas , Convulsiones/diagnóstico , Telemedicina/métodos , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Estudios Multicéntricos como Asunto , Neuroimagen , Monitorización Neurofisiológica , Estudios Observacionales como Asunto , Estudios Prospectivos , Convulsiones/diagnóstico por imagen , Grabación en VideoAsunto(s)
Enfermedades del Recién Nacido/prevención & control , Muerte Perinatal/prevención & control , Embarazo Gemelar , Nacimiento Prematuro/prevención & control , Progesterona/administración & dosificación , Administración Intravaginal , Cuello del Útero/diagnóstico por imagen , Enterocolitis Necrotizante/prevención & control , Femenino , Humanos , Recién Nacido , Embarazo , Resultado del TratamientoRESUMEN
AIM: We observed wide variation in the management of babies at risk of hypoglycaemia who participated in the hPOD (hypoglycaemia Prevention with Oral Dextrose gel) multicentre trial of prophylactic dextrose gel. The aim of this study was to identify whether this may be due to variations in the clinical guidelines used by participating hospitals. METHODS: Guidelines for management of neonatal hypoglycaemia used by participating hospitals were reviewed. Recommendations regarding definition, risk factors, monitoring and treatment were compared between countries, hospital type (tertiary or secondary) and neonatal intensive care unit size (≤12 cots and >12 cots). RESULTS: The 18 hospitals used 20 guidelines. The recommended diagnostic threshold for hypoglycaemia ranged from <2.0 mmol/L to <2.6 mmol/L, and glucose oxidase method of testing was recommended in seven (47%) of 15 guidelines. There was broad agreement about which infants should be monitored. Oral dextrose was the recommended first line of treatment in 17 of 20 guidelines, but the glucose threshold at which this should be used varied (≤2.6 mmol/L in New Zealand, 1.5-2.6 mmol/L in Australia). Re-checking blood glucose concentrations after oral dextrose was recommended at 30 min in most (10/11, 91%) New Zealand guidelines but at 60 min in most (4/6, 67%) Australian guidelines. There was greatest variation in recommended thresholds for referral to paediatric services or neonatal intensive care unit, and administration of intravenous dextrose. There were no significant differences between guidelines used by tertiary and secondary hospitals, or large and small hospitals. CONCLUSION: There is wide variation in guideline recommendations for the management of neonatal hypoglycaemia across New Zealand and Australian neonatal units.
Asunto(s)
Hipoglucemia , Enfermedades del Recién Nacido , Australia , Glucemia/análisis , Niño , Geles/uso terapéutico , Glucosa/uso terapéutico , Humanos , Hipoglucemia/diagnóstico , Hipoglucemia/tratamiento farmacológico , Hipoglucemia/prevención & control , Lactante , Recién Nacido , Enfermedades del Recién Nacido/tratamiento farmacológico , Enfermedades del Recién Nacido/prevención & control , Nueva ZelandaRESUMEN
OBJECTIVE: To assess the incidence of maternal group B Streptococcus (GBS) infection in England. DESIGN: Population surveillance augmented through data linkage. SETTING: England. POPULATION: All pregnant women accessing the National Health Service (NHS) in England. METHODS: Invasive GBS (iGBS) infections during pregnancy or within 6 weeks of childbirth were identified by linking Public Health England (PHE) national microbiology surveillance data for 2014 to NHS hospital admission records. Capsular serotypes of GBS were determined by reference laboratory typing of clinical isolates from women aged 15-44 years. Post-caesarean section surgical site infection (SSI) caused by GBS was identified in 21 hospitals participating in PHE SSI surveillance (2009-2015). MAIN OUTCOME MEASURES: iGBS rate per 1000 maternities; risk of GBS SSI per 1000 caesarean sections. RESULTS: Of 1601 patients diagnosed with iGBS infections in England in 2014, 185 (12%) were identified as maternal infections, a rate of 0.29 (95% CI 0.25-0.33) per 1000 maternities and representing 83% of all iGBS cases in women aged 18-44 years. Seven (3.8%) were associated with miscarriage. Fetal outcome identified excess rates of stillbirth (3.4 versus 0.5%) and extreme prematurity (<28 weeks of gestation, 3.7 versus 0.5%) compared with national averages (P < 0.001). Caesarean section surveillance in 27 860 women (21 hospitals) identified 47 cases of GBS SSI, with an estimated 4.24 (3.51-5.07) per 1000 caesarean sections, a median time-to-onset of 10 days (IQR 7-13 days) and ten infections that required readmission. Capsular serotype analysis identified a diverse array of strains with serotype III as the most common (43%). CONCLUSIONS: Our assessment of maternal GBS infection in England indicates the potential additional benefit of GBS vaccination in preventing adverse maternal and fetal outcomes.