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OBJECTIVE: On 2/2019, the Neonatal Antimicrobial Stewardship Program at Nationwide Children's Hospital recommended reducing empirical antibiotic therapy for early-onset sepsis (EOS) from 48 to 24 hours with a TIME-OUT. We describe our experience with this guideline and assess its safety. METHODS: Retrospective review of newborns evaluated for possible EOS at 6 NICUs from 12/2018-7/2019. Safety endpoints were re-initiation of antibiotics within 7 days after discontinuation of the initial course, positive bacterial blood or cerebrospinal fluid culture in the 7 days after antibiotic discontinuation, and overall and sepsis-related mortality. RESULT: Among 414 newborns evaluated for EOS, 196 (47%) received a 24 hour rule-out sepsis antibiotic course while 218 (53%) were managed with a 48 hour course. The 24-hour rule-out group were less likely to have antibiotics re-initiated and did not differ in the other predefined safety endpoints. CONCLUSION: Antibiotic therapy for suspected EOS may be discontinued safely within 24 hours.
Subject(s)
Intensive Care Units, Neonatal , Sepsis , Child , Infant, Newborn , Humans , Sepsis/drug therapy , Anti-Bacterial Agents/therapeutic use , Retrospective StudiesABSTRACT
BACKGROUND: Antimicrobial defined daily dose (DDD), a standardized metric to assess antimicrobial consumption in adult population, has limitations hampering its use in neonatal patients. This study proposes an alternative DDD design applicable for neonates. METHODS: Neonates (<1 month-old) from 6 Spanish hospitals during a 12-months period were included. Weight and weeks gestational age of each neonate were the variables collected. DDD (g) for each antimicrobial was calculated by multiplying the obtained weight times the recommended dose (mg/kg) of the antimicrobial for the most common infectious indication selected by the Delphi method. RESULTS: A total of 4820 neonates were included. Mean age was 36.72 weeks of gestational age and Mean weight was 2.687kg. Standardized DDD (intravenous; oral route) for representative antimicrobials were: Amoxicillin (0.08; 0.08), amoxicillin-clavulanic acid (0.27; 0.08), ampicillin (0.27; x), cloxacillin (0.13; 0.13), penicillin G sodium (0.12), cefazolin (0.13), cefuroxime (0.27; x), cefotaxime (0.27), ceftazidime (0.27), ceftriaxone (0.13), cefepime (0.27) piperacillin-tazobactam (0.54), aztreonam (0.24), azithromycin (0.03; 0.03), clindamycin (0.04; 0.04), amikacin (0.04), gentamicin (0.01), metronidazole (0.04; 0.08), ciprofloxacin (0.04; 0.05), levofloxacin (x;x), fluconazole (0.02; 0.02), itraconazole (0.01; 0.01), fosfomycin (0.27). Restricted antimicrobials: meropenem (0.11), teicoplanin (0.02), vancomycin (0.08; 0.11), linezolid (0.08; 0.08), daptomycin (x), amphotericin B liposomal (0.01). CONCLUSIONS: A useful method for antimicrobial DDD measurement in neonatology has been designed to monitor antimicrobial consumption in hospital settings. It should be validated in further studies and thereby included in the design for neonatal antimicrobial stewardship programs in the future.
Subject(s)
Anti-Infective Agents , Antimicrobial Stewardship , Anti-Bacterial Agents/therapeutic use , Ceftriaxone , Ciprofloxacin , Humans , Infant , Infant, NewbornABSTRACT
BackgroundAntimicrobial defined daily dose (DDD), a standardized metric to assess antimicrobial consumption in adult population, has limitations hampering its use in neonatal patients. This study proposes an alternative DDD design applicable for neonates.MethodsNeonates (<1 month-old) from 6 Spanish hospitals during a 12-months period were included. Weight and weeks gestational age of each neonate were the variables collected. DDD (g) for each antimicrobial was calculated by multiplying the obtained weight times the recommended dose (mg/kg) of the antimicrobial for the most common infectious indication selected by the Delphi method.ResultsA total of 4820 neonates were included. Mean age was 36.72 weeks of gestational age and Mean weight was 2.687kg. Standardized DDD (intravenous; oral route) for representative antimicrobials were: Amoxicillin (0.08; 0.08), amoxicillin-clavulanic acid (0.27; 0.08), ampicillin (0.27; x), cloxacillin (0.13; 0.13), penicillin G sodium (0.12), cefazolin (0.13), cefuroxime (0.27; x), cefotaxime (0.27), ceftazidime (0.27), ceftriaxone (0.13), cefepime (0.27) piperacillin-tazobactam (0.54), aztreonam (0.24), azithromycin (0.03; 0.03), clindamycin (0.04; 0.04), amikacin (0.04), gentamicin (0.01), metronidazole (0.04; 0.08), ciprofloxacin (0.04; 0.05), levofloxacin (x;x), fluconazole (0.02; 0.02), itraconazole (0.01; 0.01), fosfomycin (0.27). Restricted antimicrobials: meropenem (0.11), teicoplanin (0.02), vancomycin (0.08; 0.11), linezolid (0.08; 0.08), daptomycin (x), amphotericin B liposomal (0.01).
AntecedentesLa dosis diaria definida de antimicrobianos (DDD), un método estandarizado para evaluar el consumo de antimicrobianos en la población adulta, tiene limitaciones que dificultan su uso en la población neonatal. Este estudio propone un diseño alternativo de la DDD aplicable a los recién nacidos.MétodosSe incluyeron neonatos (<1 mes) de 6 hospitales españoles durante un período de 12 meses. El peso y las semanas de edad gestacional de cada recién nacido fueron las variables recogidas. Las DDD (g) de cada antimicrobiano se calcularon multiplicando el peso obtenido por la dosis recomendada (mg/kg) del antimicrobiano para la indicación infecciosa más común seleccionada por el método Delphi.ResultadosSe incluyeron un total de 4.820 recién nacidos. La edad media fue de 36,72 semanas de edad gestacional y el peso medio fue de 2,687kg. La DDD estandarizado (intravenoso; oral) para antimicrobianos seleccionados fueron: amoxicilina (0,08; 0,08), amoxicilina-ácido clavulánico (0,27; 0,08), ampicilina (0,27; x), cloxacilina (0,13; 0,13), penicilina G sódica (0,12), cefazolina (0,13), cefuroxima (0,27; x), cefotaxima (0,27), ceftazidima (0,27), ceftriaxona (0,13), cefepima (0,27) piperacilina-tazobactam (0,54), aztreonam (0,24), azitromicina (0,03; 0,03) clindamicina (0,04; 0,04), amikacina (0,04), gentamicina (0,01), metronidazol (0,04; 0,08), ciprofloxacina (0,04; 0,05), levofloxacina (x; x), fluconazol (0,02; 0,02), itraconazol (0,01; 0,01), fosfomicina (0,27). Antimicrobianos restringidos: meropenem (0,11), teicoplanina (0,02), vancomicina (0,08; 0,11), linezolid (0,08; 0,08), daptomicina (x), anfotericina B liposomal (0, 01).ConclusionesSe ha diseñado un método útil para la medición de las DDD de antimicrobianos en neonatología para controlar el consumo de antimicrobianos en entornos hospitalarios. Debería validarse en estudios posteriores para incluirse en el diseño de los programas de administración de antimicrobianos neonatales en el futuro.
Subject(s)
Humans , Infant, Newborn , Health Sciences , Anti-Bacterial Agents , Neonatology , Dosage , Communicable Diseases , Drug Therapy , Microbiology , Infant, NewbornABSTRACT
BACKGROUND: Antimicrobial defined daily dose (DDD), a standardized metric to assess antimicrobial consumption in adult population, has limitations hampering its use in neonatal patients. This study proposes an alternative DDD design applicable for neonates. METHODS: Neonates (<1 month-old) from 6 Spanish hospitals during a 12-months period were included. Weight and weeks gestational age of each neonate were the variables collected. DDD (g) for each antimicrobial was calculated by multiplying the obtained weight times the recommended dose (mg/kg) of the antimicrobial for the most common infectious indication selected by the Delphi method. RESULTS: A total of 4820 neonates were included. Mean age was 36.72 weeks of gestational age and Mean weight was 2.687kg. Standardized DDD (intravenous; oral route) for representative antimicrobials were: Amoxicillin (0.08; 0.08), amoxicillin-clavulanic acid (0.27; 0.08), ampicillin (0.27; x), cloxacillin (0.13; 0.13), penicillin G sodium (0.12), cefazolin (0.13), cefuroxime (0.27; x), cefotaxime (0.27), ceftazidime (0.27), ceftriaxone (0.13), cefepime (0.27) piperacillin-tazobactam (0.54), aztreonam (0.24), azithromycin (0.03; 0.03), clindamycin (0.04; 0.04), amikacin (0.04), gentamicin (0.01), metronidazole (0.04; 0.08), ciprofloxacin (0.04; 0.05), levofloxacin (x;x), fluconazole (0.02; 0.02), itraconazole (0.01; 0.01), fosfomycin (0.27). Restricted antimicrobials: meropenem (0.11), teicoplanin (0.02), vancomycin (0.08; 0.11), linezolid (0.08; 0.08), daptomycin (x), amphotericin B liposomal (0.01). CONCLUSIONS: A useful method for antimicrobial DDD measurement in neonatology has been designed to monitor antimicrobial consumption in hospital settings. It should be validated in further studies and thereby included in the design for neonatal antimicrobial stewardship programs in the future.
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INTRODUCCIÓN: La repercusión de la infección materna por SARS-CoV-2 y su riesgo de transmisión vertical es aún poco conocido. Las recomendaciones de las sociedades científicas buscan proporcionar seguridad para el recién nacido sin comprometer los beneficios del contacto precoz. El objetivo del estudio es describir las características y la evolución de recién nacidos de madres infectadas por SARS-CoV-2, así como las medidas implementadas siguiendo las recomendaciones de la Sociedad Española de Neonatología. MATERIAL Y MÉTODOS: Estudio observacional, prospectivo y unicentro de cohortes. Se diseñó un circuito específico para madres con infección por SARS-CoV-2 y sus hijos. Se recogieron datos epidemiológicos y clínicos de las madres y sus recién nacidos. Se realizó PCR al nacer y a los 14 días. RESULTADOS: Se incluyeron 73 madres y 75 neonatos. El 95,9% de infecciones maternas fueron diagnosticadas durante el tercer trimestre, el 43,8% fueron asintomáticas. La mediana de edad gestacional fue de 38 semanas (RIC: 37-40), el 25,9% de los neonatos requirió ingreso. En el 68% se realizó contacto piel con piel en paritorio y el 80% recibieron lactancia materna o donada exclusiva durante su estancia. No se objetivaron resultados positivos de PCR en la primera muestra obtenida nada más nacer, se objetivó un caso de PCR positiva en un neonato asintomático a los 14 días. CONCLUSIONES: El riesgo de transmisión de la infección por SARS-CoV-2 es bajo cumpliendo los protocolos de la Sociedad Española de Neonatología, permitiendo el alojamiento conjunto de madre e hijo, el contacto precoz y el establecimiento eficaz de la lactancia materna
INTRODUCTION: The impact of maternal SARS-CoV-2 infection and its risk of vertical transmission is still not well known. Recommendations from scientific societies seek to provide safety for newborns without compromising the benefits of early contact. The aim of the study is to describe characteristics and evolution of newborns born to mothers with SARS-CoV-2 infection, as well as the implemented measures following recommendations from the Sociedad Española de Neonatología. METHODS: Observational, prospective and single-center cohort study. A specific circuit was designed for mothers with SARS-CoV-2 infection and their newborns. Epidemiological and clinical data were collected. PCR were performed in newborns at delivery and at 14 days of age. RESULTS: 73 mothers and 75 newborns were included in the study. 95.9% of maternal infections were diagnosed during the third trimester of pregnancy, 43.8% were asymptomatic. Median gestational age was 38 weeks (IQR: 37-40), 25.9% of newborns required admission to Neonatology. Skin-to-skin mother care was performed in 68% of newborns, 80% received exclusive maternal or donated breast milk during hospital stay. No positive PCR results were observed in newborns at delivery, one case of positive PCR was observed in an asymptomatic neonate at 14 days of age. CONCLUSIONS: Risk of SARS-CoV-2 transmission is low when complying to the recommendations issued by Sociedad Española de Neonatología, allowing rooming-in and promoting breastfeeding
Subject(s)
Humans , Female , Pregnancy , Infant, Newborn , Adult , Pregnancy Complications, Infectious/epidemiology , Coronavirus Infections/epidemiology , Pneumonia, Viral/epidemiology , Pandemics , Coronavirus Infections/prevention & control , Pneumonia, Viral/prevention & control , Prospective Studies , Cohort Studies , Risk FactorsABSTRACT
BACKGROUND: Global assessment of antimicrobial agents prescribed to infants in the neonatal intensive care unit (NICU) may inform antimicrobial stewardship efforts. METHODS: We conducted a one-day global point prevalence study of all antimicrobials provided to NICU infants. Demographic, clinical, and microbiologic data were obtained including NICU level, census, birth weight, gestational/chronologic age, diagnoses, antimicrobial therapy (reason for use; length of therapy), antimicrobial stewardship program (ASP), and 30-day in-hospital mortality. FINDINGS: On July 1, 2019, 26% of infants (580/2,265; range, 0-100%; median gestational age, 33 weeks; median birth weight, 1800 g) in 84 NICUs (51, high-income; 33, low-to-middle income) from 29 countries (14, high-income; 15, low-to-middle income) in five continents received ≥1 antimicrobial agent (92%, antibacterial; 19%, antifungal; 4%, antiviral). The most common reasons for antibiotic therapy were "rule-out" sepsis (32%) and "culture-negative" sepsis (16%) with ampicillin (40%), gentamicin (35%), amikacin (19%), vancomycin (15%), and meropenem (9%) used most frequently. For definitive treatment of presumed/confirmed infection, vancomycin (26%), amikacin (20%), and meropenem (16%) were the most prescribed agents. Length of therapy for culture-positive and "culture-negative" infections was 12 days (median; IQR, 8-14) and 7 days (median; IQR, 5-10), respectively. Mortality was 6% (42%, infection-related). An NICU ASP was associated with lower rate of antibiotic utilization (p = 0·02). INTERPRETATION: Global NICU antibiotic use was frequent and prolonged regardless of culture results. NICU-specific ASPs were associated with lower antibiotic utilization rates, suggesting the need for their implementation worldwide. FUNDING: Merck & Co.; The Ohio State University College of Medicine Barnes Medical Student Research Scholarship.
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INTRODUCTION: The impact of maternal SARS-CoV-2 infection and its risk of vertical transmission is still not well known. Recommendations from scientific societies seek to provide safety for newborns without compromising the benefits of early contact. The aim of the study is to describe characteristics and evolution of newborns born to mothers with SARS-CoV-2 infection, as well as the implemented measures following recommendations from the Sociedad Española de Neonatología. METHODS: Observational, prospective and single-center cohort study. A specific circuit was designed for mothers with SARS-CoV-2 infection and their newborns. Epidemiological and clinical data were collected. PCR were performed in newborns at delivery and at 14 days of age. RESULTS: 73 mothers and 75 newborns were included in the study. 95.9% of maternal infections were diagnosed during the third trimester of pregnancy, 43.8% were asymptomatic. Median gestational age was 38 weeks (IQR: 37-40), 25.9% of newborns required admission to Neonatology. Skin-to-skin mother care was performed in 68% of newborns, 80% received exclusive maternal or donated breast milk during hospital stay. No positive PCR results were observed in newborns at delivery, one case of positive PCR was observed in an asymptomatic neonate at 14 days of age. CONCLUSIONS: Risk of SARS-CoV-2 transmission is low when complying to the recommendations issued by Sociedad Española de Neonatología, allowing rooming-in and promoting breastfeeding.
INTRODUCCIÓN: La repercusión de la infección materna por SARS-Cov-2 y su riesgo de transmisión vertical es aún poco conocido. Las recomendaciones de las sociedades científicas buscan proporcionar seguridad para el recién nacido sin comprometer los beneficios del contacto precoz. El objetivo del estudio es describir las características y evolución de recién nacidos de madres infectadas por SARS-CoV2, así como las medidas implementadas siguiendo las recomendaciones de la Sociedad Española de Neonatología. MATERIAL Y MÉTODOS: Estudio observacional, prospectivo y unicentro de cohortes. Se diseñó un circuito específico para madres con infección por SARS-CoV2 y sus hijos. Se recogieron datos epidemiológicos y clínicos de las madres y sus recién nacidos. Se realizó PCR al nacer y a los 14 días. RESULTADOS: Se incluyeron 73 madres y 75 neonatos. El 95.9% de infecciones maternas fueron diagnosticadas durante el tercer trimestre, el 43.8% fueron asintomáticas. La mediana de edad gestacional fue 38 semanas (RIC:3740), el 25.9% de los neonatos requirió ingreso. En el 68% se realizó contacto piel con piel en paritorio y el 80% recibieron lactancia materna o donada exclusiva durante su estancia. No se objetivaron resultados positivos de PCR en la primera muestra obtenida nada más nacer, se objetivó 1 caso de PCR positiva en un neonato asintomático a los 14 días. CONCLUSIONES: El riesgo de transmisión de la infección por SARS-CoV2 es bajo cumpliendo los protocolos de la Sociedad Española de Neonatología, permitiendo el alojamiento conjunto de madre e hijo, el contacto precoz y el establecimiento eficaz de la lactancia materna.
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INTRODUCTION: The impact of maternal SARS-CoV-2 infection and its risk of vertical transmission is still not well known. Recommendations from scientific societies seek to provide safety for newborns without compromising the benefits of early contact. The aim of the study is to describe characteristics and evolution of newborns born to mothers with SARS-CoV-2 infection, as well as the implemented measures following recommendations from the Sociedad Española de Neonatología. METHODS: Observational, prospective and single-center cohort study. A specific circuit was designed for mothers with SARS-CoV-2 infection and their newborns. Epidemiological and clinical data were collected. PCR were performed in newborns at delivery and at 14 days of age. RESULTS: 73 mothers and 75 newborns were included in the study. 95.9% of maternal infections were diagnosed during the third trimester of pregnancy, 43.8% were asymptomatic. Median gestational age was 38 weeks (IQR: 37-40), 25.9% of newborns required admission to Neonatology. Skin-to-skin mother care was performed in 68% of newborns, 80% received exclusive maternal or donated breast milk during hospital stay. No positive PCR results were observed in newborns at delivery, one case of positive PCR was observed in an asymptomatic neonate at 14 days of age. CONCLUSIONS: Risk of SARS-CoV-2 transmission is low when complying to the recommendations issued by Sociedad Española de Neonatología, allowing rooming-in and promoting breastfeeding.
Subject(s)
COVID-19 , Infectious Disease Transmission, Vertical/statistics & numerical data , Pregnancy Complications, Infectious , Adult , Breast Feeding , COVID-19/diagnosis , COVID-19/epidemiology , COVID-19/therapy , COVID-19/transmission , COVID-19 Testing , Female , Humans , Infant Care/methods , Infant, Newborn , Male , Perinatal Care/methods , Pregnancy , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/epidemiology , Pregnancy Complications, Infectious/therapy , Prospective Studies , Spain/epidemiologyABSTRACT
OBJECTIVES: To describe neonatal and maternal characteristics of the largest prospective cohort of newborns from mothers with coronavirus disease 2019 (COVID-19), the data of which were prospectively collected from the nationwide registry of the Spanish Society of Neonatology. METHODS: Between March 8, 2020, and May 26, 2020, the data of 503 neonates born to 497 mothers diagnosed with COVID-19 during pregnancy or at the time of delivery were collected by 79 hospitals throughout Spain. RESULTS: Maternal symptoms were similar to that of the general population, with 5% of severe forms. In 45.8% of asymptomatic women at the time of delivery, severe acute respiratory syndrome coronavirus 2 infection was detected because of recommendations established in Spain to perform COVID-19 screening in all women admitted to the hospital for labor. The rate of preterm deliveries was 15.7% and of cesarean deliveries, 33%. The most common diagnostic test was detection of viral RNA by polymerase chain reaction of nasopharyngeal swabs at a median age of 3 hours after delivery (1-12 hours). Almost one-half of neonates were left skin-to-skin after delivery, and delayed clamping of umbilical cords was performed in 43% of neonates. Also, 62.3% of asymptomatic neonates were managed with rooming-in. Maternal milk was received by 76.5% of neonates, 204 of them as exclusive breastfeeding. CONCLUSIONS: The current study indicates that there is no need for separation of mothers from neonates, allowing delayed cord clamping and skin-to-skin contact along with maintenance of breastfeeding in a high percentage of newborns from mothers with COVID-19.
Subject(s)
COVID-19/epidemiology , Pregnancy Complications, Infectious/epidemiology , Adult , Breast Feeding , COVID-19/transmission , Cesarean Section/statistics & numerical data , Female , Humans , Infant, Newborn , Infant, Premature , Infectious Disease Transmission, Vertical , Kangaroo-Mother Care Method , Pandemics , Pregnancy , Prospective Studies , Registries , Rooming-in Care , SARS-CoV-2 , Spain/epidemiologyABSTRACT
Objective: Coronavirus disease 2019 (COVID-19) cases caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continue to increase worldwide. Although some data from pediatric series are available, more evidence is required, especially in neonates, a group with specific characteristics that deserve special attention. This study aimed to describe general and clinical characteristics, management, and treatment of postnatal-acquired (community and nosocomial/hospital-acquired) COVID-19 neonatal cases in Spain. Methods: This was a national prospective epidemiological study that included cases from a National Registry supported by the Spanish Society of Neonatology. Neonates with postnatal SARS-CoV-2 infection were included in this study. General data and infection-related information (mode and source of transmission, age at diagnosis, clinical manifestations, need for hospitalization, admission unit, treatment administered, and complementary studies performed, hospital stay associated with the infection) were collected. Results: A total of 40 cases, 26 community-acquired and 14 nosocomial were registered. Ten were preterm newborns (2 community-acquired and 8 nosocomial COVID-19 cases). Mothers (in both groups) and healthcare workers (in nosocomial cases) were the main source of infection. Hospital admission was required in 22 community-acquired cases [18 admitted to the neonatal intermediate care unit (NIMCU) and 4 to the neonatal intensive care unit (NICU)]. Among nosocomial COVID-19 cases (n = 14), previously admitted for other reasons, 4 were admitted to the NIMCU and 10 to the NICU. Ten asymptomatic patients were registered (5 in each group). In the remaining cases, clinical manifestations were generally mild in both groups, including upper respiratory airways infection, febrile syndrome or acute gastroenteritis with good overall health. In both groups, most severe cases occurred in preterm neonates or neonates with concomitant pathologies. Most of the cases did not require respiratory support. Hydroxychloroquine was administered to 4 patients in the community-acquired group and to 2 patients in the nosocomial group. Follow-up after hospital discharge was performed in most patients. Conclusions: This is the largest series of COVID-19 neonatal cases in Spain published to date. Although clinical manifestations were generally mild, prevention, treatment, and management in this group are essential.
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BACKGROUND: Noninvasive ventilation is being increasingly used on preterm infants to reduce ventilator lung injury and bronchopulmonary dysplasia. The aim of this study was to evaluate the effectiveness of synchronized nasal intermittent positive pressure ventilation (SNIPPV) to prevent intubation in premature infants. METHODS: Prospective observational study of SNIPPV use on preterm infants of less than 32 weeks' gestation. All patients were managed using a prospective protocol intended to reduce invasive mechanical ventilation (iMV) use. Previous respiratory status, as well as respiratory outcomes and possible secondary side effects were analyzed. RESULTS: SNIPPV was used on 78 patients: electively to support extubation on 25 ventilator-dependent patients and as a rescue therapy after nasal continuous positive airway pressure failure on 53 patients. For 92% of patients in the elective group and 66% in the rescue group, iMV was avoided over the following 72 hours. No adverse effects were detected, and all patients were in a stable condition even if intubation was eventually needed. CONCLUSIONS: The application of SNIPPV in place of or to remove mechanical ventilation avoids intubation in 74.4% of preterm infants with respiratory failure. No adverse effects were detected.
