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OBJECTIVE: To define percentile charts for arterial oxygen saturation (SpO2), heart rate (HR), and cerebral oxygen saturation (crSO2) during the first 15 minutes after birth in neonates born very or extremely preterm and with favorable outcome. STUDY DESIGN: We conducted a secondary-outcome analysis of neonates born preterm included in the Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth III (COSGOD III) trial with visible cerebral oximetry measurements and with favorable outcome, defined as survival without cerebral injuries until term age. We excluded infants with inflammatory morbidities within the first week after birth. SpO2 was obtained by pulse oximetry, and electrocardiogram or pulse oximetry were used for measurement of HR. crSO2 was assessed with near-infrared spectroscopy. Measurements were performed during the first 15 minutes after birth. Percentile charts (10th to 90th centile) were defined for each minute. RESULTS: A total of 207 neonates born preterm with a gestational age of 29.7 (23.9-31.9) weeks and a birth weight of 1200 (378-2320) g were eligible for analyses. The 10th percentile of SpO2 at minute 2, 5, 10, and 15 was 32%, 52%, 83%, and 85%, respectively. The 10th percentile of HR at minute 2, 5, 10, and 15 was 70, 109, 126, and 134 beats/min, respectively. The 10th percentile of crSO2 at minute 2, 5, 20, and 15 was 15%, 27%, 59%, and 63%, respectively. CONCLUSIONS: This study provides new centile charts for SpO2, HR, and crSO2 for neonates born extremely or very preterm with favorable outcome. Implementing these centiles in guiding interventions during the stabilization process after birth might help to more accurately target oxygenation during postnatal transition period.
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Frequência Cardíaca , Lactente Extremamente Prematuro , Oximetria , Saturação de Oxigênio , Humanos , Recém-Nascido , Frequência Cardíaca/fisiologia , Saturação de Oxigênio/fisiologia , Feminino , Masculino , Oximetria/métodos , Valores de Referência , Espectroscopia de Luz Próxima ao Infravermelho , Recém-Nascido Prematuro , Oxigênio/metabolismo , Oxigênio/sangue , Encéfalo/metabolismo , Idade GestacionalRESUMO
Changes in the organization of the clinical care wards, requested by the SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) pandemic, have influenced the environmental circulation of other pathogens. The implementation of prevention procedures may have led to a decrease in the incidence of healthcare-associated infections. We aimed to investigate the impact of prevention and control measures for preventing the COVID-19 spread on the incidence of bacterial sepsis and invasive fungal infections in neonates and infants requiring major surgery. We compared the incidence of bacterial and fungal sepsis and their risk factors observed before the SARS-CoV-2 pandemic (from 01/10/2018 to 29/02/2020) with those observed during the pandemic (from 01/03/2020 to 07/05/2021) in 13 level III Neonatal Intensive Care Units in Italy, through a secondary analysis of data, collected during a prospective multicenter study (REF). The patients enrolled were infants within three months of life, hospitalized in the two periods in the participating centers to undergo major surgery. Among 541 enrolled patients, 324 (59.9%) were born in the pre-pandemic period and 217 (40.1%) during the pandemic. The incidence density (ID) of any infection in the pre-pandemic period was 16.0/1000 patient days versus 13.6/1000 patient days in the pandemic period (p < 0.001). One hundred and forty-five (145/324; 44.8%) patients developed at least one episode of bacterial sepsis in the pre-pandemic period, versus 103/217 (31.8%) patients, during the pandemic (p = 0.539). Concerning fungal sepsis, 12 (3.7%) patients had one episode in the pre-pandemic period versus 11 (5.1%) patients during the pandemic (p = 0.516). The most significant differences observed in the use of healthcare procedures were the reduction of CVC days, the reduced use of antibiotics pre-surgery, and that of proton pump inhibitors during the SARS-CoV-2 pandemic compared with the previous period. CONCLUSIONS: In our cohort of patients with major surgical needs, the reduction of CVC days, pre-surgery antibiotics administration, and current use of proton pump inhibitors, during the SARS-CoV-2 pandemic, led to a decrease in the incidence of late-onset sepsis. WHAT IS KNOWN: ⢠Most cases of late-onset sepsis in neonates are referred to as central line-associated bloodstream infections. ⢠In adults, the COVID-19 outbreak negatively influenced healthcare-associated infection rates and infection clusters within hospitals. WHAT IS NEW: ⢠In neonates and infants undergoing major surgery the incidence density of infections was lower in the pandemic period than before. ⢠The most significant differences observed in the use of healthcare procedures were the reduction of CVC days, the reduced use of antibiotics before surgery, and that of proton pump inhibitors during the pandemic compared with previously.
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COVID-19 , Infecção Hospitalar , Sepse , Adulto , Recém-Nascido , Humanos , Lactente , SARS-CoV-2 , COVID-19/epidemiologia , Estudos Prospectivos , Pandemias/prevenção & controle , Incidência , Inibidores da Bomba de Prótons , Sepse/epidemiologia , Sepse/etiologia , Infecção Hospitalar/epidemiologia , Itália/epidemiologia , AntibacterianosRESUMO
AIM: Smaller cerebellar volumes in very low-birthweight (VLBW) infants at term have been related to adverse cognitive outcomes, and this study evaluated whether these volumes were associated with a growth in body composition during hospital stays. METHODS: We prospectively recruited 42 VLBW infants from an Italian neonatal unit between January 2013 and August 2015. Cerebellar volumes and body composition were measured by magnetic resonance imaging (MRI) and air-displacement plethysmography, respectively, at 40 weeks of gestational age and anthropometric and nutritional data were collected. We also included 20 term-born controls. RESULTS: The mean gestational age and birthweight of the VLBW infants were 29.4 (±1.9) weeks and 1120 (±290) g. There was a positive correlation between cerebellar volumes and daily weight gain from birth to term (R2 = 0.26, p = 0.001), weight (R2 = 0.25, p = 0.001), length (R2 = 0.16, p = 0.01), fat mass (R2 = 0.15, p = 0.01) and fat-free mass at term (R2 = 0.20, p = 0.003). In multiple regression analysis, daily weight gain, mechanical ventilation and postconceptional age at MRI were independently associated with cerebellar volumes. Anthropometric data and cerebellar volumes were similar between VLBW and control infants. CONCLUSION: Higher growth, higher fat mass and fat-free mass were associated with larger cerebellar volumes in VLBW infants at term.
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Cerebelo/anatomia & histologia , Recém-Nascido Prematuro/crescimento & desenvolvimento , Recém-Nascido de muito Baixo Peso/crescimento & desenvolvimento , Composição Corporal , Desenvolvimento Infantil , Feminino , Humanos , Recém-Nascido , Masculino , Estado Nutricional , Tamanho do Órgão , Estudos Prospectivos , Análise de RegressãoAssuntos
Recém-Nascido Prematuro , Leite , Animais , Conteúdo Gastrointestinal , Humanos , Lactente , Recém-Nascido , Leite HumanoRESUMO
OBJECTIVE: To compare growth, fat mass (FM), and fat-free mass in surgical infants vs matched controls at similar postconceptional age (PCA). STUDY DESIGN: Anthropometric and body composition measurements by air-displacement plethysmography (PeaPod-Infant Body Composition System; LMI, Concord, California) were performed at the same PCA in 21 infants who received gastrointestinal surgery and in 21 controls matched for gestational age, birth weight, and sex. RESULTS: Despite similar anthropometry at birth, postsurgical infants were shorter (50.4 [4.7] cm vs 53.2 [4.1] cm, P = .001), lighter (3516 [743] g vs 3946 [874] g, P < .001), and had lower FM content (%FM 14.8 [4.7]% vs 20.2 [5.8]%, P < .0001) than their peers at similar PCA (43 [4] weeks). All surgical infants but 1 (20/21) received parenteral nutrition (PN). Mean PN duration was 40 (30) days. Five infants in the control group received PN because of prematurity for 15 (9-30) days. Nine infants in the surgical group and 1 in the control group had PN-associated cholestasis. CONCLUSIONS: Neonates having surgery for gastrointestinal diseases were shorter, had lower weight, and lower FM content than their peers, despite receiving more PN. Body composition evaluation and monitoring may help optimize growth in these newborns.
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Tecido Adiposo/fisiopatologia , Composição Corporal/fisiologia , Peso Corporal , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Gastroenteropatias/cirurgia , Antropometria , Peso ao Nascer , Estudos de Casos e Controles , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Doenças do Recém-Nascido , Masculino , Nutrição ParenteralRESUMO
PURPOSE: Breastfeeding women may suffer from migraine. While we have many drugs for its treatment and prophylaxis, the majority are poorly studied in breastfeeding women. We conducted a review of the most common anti-migraine drugs (AMDs) and we determined their lactation risk. METHODS: For each AMD, we collected all retrievable data from Hale's Medications and Mother Milk (2012), from the LactMed database (2014) of the National Library of Medicine, and from a MedLine Search of relevant studies published in the last 10 years. RESULTS: According to our review, AMDs safe during breastfeeding are as follows: low-dose acetylsalicylic acid (ASA), ibuprofen, sumatriptan, metoprolol, propranolol, verapamil, amitriptyline, escitalopram, paroxetine, sertraline, acetaminophen, caffeine, and metoclopramide. AMDs compatible with breastfeeding but warranting caution are as follows: diclofenac, ketoprofen, naproxen, most new triptans, topiramate, valproate, venlafaxine, and cyproheptadine. Finally, high-dose ASA, atenolol, nadolol, cinnarizine, flunarizine, ergotamine, methysergide, and pizotifen are contraindicated. CONCLUSIONS: According to our review, the majority of the revised AMDs were assessed to be compatible with breastfeeding.
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Aleitamento Materno , Transtornos de Enxaqueca/tratamento farmacológico , Antagonistas Adrenérgicos beta/farmacocinética , Antagonistas Adrenérgicos beta/uso terapêutico , Analgésicos não Narcóticos/farmacocinética , Analgésicos não Narcóticos/uso terapêutico , Animais , Anti-Inflamatórios não Esteroides/farmacocinética , Anti-Inflamatórios não Esteroides/uso terapêutico , Anticonvulsivantes/farmacocinética , Anticonvulsivantes/uso terapêutico , Antidepressivos/farmacocinética , Antidepressivos/uso terapêutico , Bloqueadores dos Canais de Cálcio/farmacocinética , Bloqueadores dos Canais de Cálcio/uso terapêutico , Feminino , Humanos , Transtornos de Enxaqueca/metabolismo , Triptaminas/farmacocinética , Triptaminas/uso terapêuticoRESUMO
BACKGROUND: Benefits of different types of family-centred care (FCC) interventions in neonatal intensive care units (NICUs) have been reported. However, a comprehensive review of existing FCC intervention studies was lacking. OBJECTIVE: This review aimed at synthesising the characteristics of FCC interventions, related outcomes and measurement methods in randomised controlled trials (RCTs) in NICU, and providing menus of options to favour implementation and further research. METHODS: We searched PubMed, EMBASE, Web of Science and the Cochrane Library up to 31 January 2022. Interventions were mapped according to five categories as defined by a previous Cochrane review. We described outcome types, measurement populations, measurement methods and timelines. Subgroup analyses were also performed. RESULTS: Out of 6583 studies identified, 146 met eligibility criteria. Overall, 52 (35.6%) RCTs tested more than one category of intervention, with a large variety of combinations, with the most frequent category of intervention being the educational (138 RCTs, 94.5%). We identified a total of 77 different intervention packages, and RCTs comparing the same interventions were lacking. The 146 RCTs reported on 425 different outcomes, classified in 13 major categories with parental mental health (61 RCTs, 41.8% of total RCTs) being the most frequent category in parents, and neurobehavioural/developmental outcomes being the most frequent category in newborns (62 RCTs, 42.5%). For several categories of outcomes almost every RCT used a different measurement method. Educational interventions targeting specifically staff, fathers, siblings and other family members were lacking or poorly described. Only one RCT measured outcomes in health workers, two in siblings and none considered other family members. CONCLUSIONS: A large variety of interventions, outcomes and measurement methods were used in FCC studies in NICU. The derived menus of options should be helpful for researchers and policy makers to identify interventions most suitable in each setting and to further standardise research methods.
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Unidades de Terapia Intensiva Neonatal , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Recém-NascidoRESUMO
Introduction: Breastfeeding is a fundamental biological function in mammals, allowing the progeny to develop in a physiological way. A physical and emotional dialog between mothers and offspring during breastfeeding has been described as part of the attachment relationship, and a synchronicity between maternal and neonatal brains can be hypothesized. This study aimed to assess if neonatal and maternal cortical areas activated during breastfeeding are functionally synchronized since the second day of life. Materials and Methods: Twenty mothers and their term newborns were enrolled. Cortical activation during breastfeeding was identified by multichannel near-infrared spectroscopy, which detects changes in haemoglobin concentration from multiple cortical regions. Functional activity was simultaneously detected (hyperscanning) in mothers and newborns' frontal and motor/primary somatosensory cortical areas during the first 5 minutes of breastfeeding. Cluster analysis and Student's t test were used to detect oxygenated haemoglobin increase, as cortical activation estimate. Wavelet transform coherence (WTC) analysis was used to identify a possible synchronization between maternal and neonatal activated cortical regions. Results: Mothers showed an activation of the central motor/primary somatosensory cortex, above the sagittal fissure. In newborns, the bilateral frontal cortex was activated. WTC analysis revealed two different cyclical synchronizations between mothers and infants' activated cortical regions. Conclusions: Such evidence may reflect a very early common sharing of experiences, possibly associated with reciprocal dynamic motor adjustments, hormonal coregulation, and somatic stimulations and sensations. The observed cyclical neural synchronization, between the mother and her newborn's cortex during breastfeeding, may play an important role in promoting their bonding.
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Aleitamento Materno , Relações Mãe-Filho , Mães , Espectroscopia de Luz Próxima ao Infravermelho , Humanos , Feminino , Recém-Nascido , Adulto , Mães/psicologia , Masculino , Sincronização Cortical/fisiologia , Córtex Somatossensorial/fisiologiaRESUMO
BACKGROUND: This study aimed at documenting the levels of stress, depression, anxiety and participation in care among mothers versus fathers of newborns hospitalised in a third-level neonatal intensive care unit (NICU) in Northern Italy. METHODS: Parental stress, depression and anxiety were assessed by the Parental Stressor Scale in NICU (PSS:NICU), the Edinburgh Postnatal Depression Scale (EPDS) and the State-Trait Anxiety Inventory (STAI). Participation in care was evaluated with the Index of Parental Participation. Differences between mothers and fathers were assessed with the Mood's median test and z-test, respectively for continuous and discrete variables. Multivariate analyses controlling for potential confounders were performed to confirm gender differences. RESULTS: 191 parents (112 mothers and 79 fathers) were enrolled. Mothers reported significantly higher median scores for stress (2.9 vs 2.2, p<0.001) and trait anxiety (37 vs 32, p=0.004) and higher depression rates (EPDS ≥12: 43.8% vs 19.0%, p<0.001). 'High stress' (PSS:NICU ≥3) was reported by 45.5% of mothers compared with 24.1% of fathers (p=0.004). The frequency of the three conditions simultaneously was significantly higher among mothers (20.0% vs 3.8%, p=0.016), with the vast majority of mothers (76.0%) suffering from at least one condition compared with less than half of fathers (45.3%, p<0.001). Participation in care was more frequent in mothers (median score: 19 vs 15, p<0.001), with the exception of activities related to advocacy (median 5 vs 4, p=0.053). In a multivariate analysis, gender differences in mental health outcomes did not change. CONCLUSIONS: Routine screening of mental distress among parents of infants in NICU is warranted, and gender differences need to be acknowledged in order to deliver tailored support and to promote collaboration with the family of vulnerable newborns. Knowledge and skills on how to prevent and cope with mental distress of parents should be part of the core curriculum of staff working in NICU.
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Depressão , Unidades de Terapia Intensiva Neonatal , Feminino , Lactente , Humanos , Recém-Nascido , Estudos Transversais , Depressão/epidemiologia , Depressão/diagnóstico , Estresse Psicológico/epidemiologia , Estresse Psicológico/psicologia , Pais/psicologia , Ansiedade/epidemiologia , Ansiedade/diagnóstico , Ansiedade/psicologiaRESUMO
BACKGROUND: Different definitions of family-centred care (FCC) exist in the newborn setting, and many FCC interventions have been tested, while a comprehensive review synthesising characteristics of existing intervention studies is still lacking. OBJECTIVE: This review aims at summarising the characteristics of randomised controlled trials (RCTs) on FCC interventions in neonatal intensive care units. METHODS: We searched PubMed, Embase, Web of Science and the Cochrane Library up to 31 January 2022, and reference lists of included studies and other reviews. Interventions were grouped into five categories according to a previous Cochrane review: (1) family support, (2) educational, (3) communication, (4) environmental interventions and (5) family-centred policies. Subgroup analyses by time period (RCTs published before vs after 2016) and by country income (based on the World Bank Classification) were conducted. RESULTS: Out of 6583 retrieved studies, 146 RCTs met the eligibility criteria, with 53 (36.3%) RCTs published after 2016. Overall, 118 (80.8%) RCTs were conducted in high-income countries, 28 (19.1%) in middle-income countries and none in low-income countries. Only two RCTs were multicountry. Although mothers were the most frequent caregiver involved, fathers were included in 41 RCTs (28.1%). Very few studies were conducted in at-term babies (nine RCTs); siblings (two RCTs) and other family members (two RCTs), maternity care units (two RCTs). The role of health professionals was unclear in 65 (44.5%) RCTs. A large variety of intervention combinations was tested, with 52 (35.6%) RCTs testing more than 1 category of interventions, and 24 (16.4%) RCTs including all 5 categories. CONCLUSION: There is a large and rising number of RCTs on FCC interventions in neonatal intensive care units, with specific research gaps. The large variety of FCC interventions, their high complexity, the need to tailor them to the local context and major gaps in implementation suggest that implementation research is the current priority.
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Unidades de Terapia Intensiva Neonatal , Ensaios Clínicos Controlados Aleatórios como Assunto , Humanos , Recém-NascidoRESUMO
BACKGROUND: Studies comparing the frequency of different mental health conditions across different settings and evaluating their association with parental participation in newborn care are lacking. We aimed at evaluating the frequency of parental stress, anxiety and depression, along with the level of participation in newborn care, among parents of newborns in Italy, Brazil and Tanzania. METHODS: Parental stress, anxiety, depression and participation in care were assessed prospectively in parents of newborns in eight neonatal intensive care units (NICUs) utilising: the Parental Stressor Scale in NICU (PSS:NICU); the Edinburgh Postnatal Depression Scale (EPDS) and EPDS-Anxiety subscale (EPDS-A); the Index of Parental Participation in NICU (IPP-NICU). Univariate and multivariate analyses were conducted. RESULTS: Study outcomes were assessed on 742 parents (Brazil=327, Italy=191, Tanzania=224). Observed scores suggested a very high frequency of stress, anxiety and depression, with an overall estimated frequency of any of the mental health condition of 65.1%, 52.9% and 58.0% in Brazil, Italy, Tanzania, respectively (p<0.001). EPDS scores indicating depression (cut-off: ≥13 for Brazil and Tanzania, ≥12 for Italy) were significantly more frequent in Tanzania (52.3%) when compared with either Brazil (35.8%) and Italy (33.3%) (p<0.001). Parental participation in care was also significantly higher in Tanzania (median IPP-NICU=24) than in the other two countries (median=21 for Brazil, 18 for Italy, p<0.001). Severe stress (PSS:NICU ≥4) was significantly more frequently reported in Brazil (22.6%), compared with Italy (4.7%) and Tanzania (0%, p<0.001). Factors independently associated with either parental stress, anxiety or depression varied by country, and a significant association with parental participation in care was lacking. CONCLUSIONS: Study findings suggest that parental stress, anxiety and depression are extremely frequent in NICUs in all countries despite diversity in the setting, and requiring immediate action. Further studies should explore the appropriate level of parental participation in care in different settings.
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Ansiedade , Depressão , Unidades de Terapia Intensiva Neonatal , Pais , Estresse Psicológico , Humanos , Unidades de Terapia Intensiva Neonatal/estatística & dados numéricos , Estudos Prospectivos , Feminino , Masculino , Estresse Psicológico/epidemiologia , Ansiedade/epidemiologia , Ansiedade/psicologia , Recém-Nascido , Depressão/epidemiologia , Depressão/psicologia , Itália/epidemiologia , Adulto , Pais/psicologia , Tanzânia/epidemiologia , Brasil/epidemiologia , Escalas de Graduação PsiquiátricaAssuntos
Adjuvantes Anestésicos/administração & dosagem , Anestesia/métodos , Dexmedetomidina/administração & dosagem , Recém-Nascido Prematuro , Midazolam/administração & dosagem , Administração Intranasal , Dexmedetomidina/efeitos adversos , Humanos , Hipnóticos e Sedativos/administração & dosagem , Hipnóticos e Sedativos/efeitos adversos , Recém-Nascido , Imageamento por Ressonância Magnética/métodos , Estudos ProspectivosRESUMO
BACKGROUND: Although twin gestation is well recognized to be associated with impaired fetal and postnatal growth, specific data about body composition of twins in the first month of life are scarce. OBJECTIVE: The aim of this study was to compare the body composition of twins, evaluated with air-displacement plethysmography, to that of singletons of similar gestational age and adequacy of growth, during the first month of life. We tested the hypothesis that the quality of growth would be similar. METHODS: Anthropometric and air-displacement plethysmography measurements were performed in 18 pairs of twins and in 36 singleton neonates, longitudinally, from birth to the 30th day of life. Each twin was matched to a singleton infant of similar gestational age and birth weight z-score. RESULTS: With regard to anthropometric measures, the only difference was a lower weight in twins versus singletons on the 15th day of life. With regard to body composition, we did not find any difference between groups at any time point. Fat mass increased significantly from day 1 to day 30 in both twins and singletons. CONCLUSION: In terms of body composition, twins do not differ from singletons of similar gestational age and weight, either at birth or in early postnatal life.
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Composição Corporal , Gêmeos , Tecido Adiposo , Antropometria , Peso ao Nascer , Estudos de Casos e Controles , Feminino , Idade Gestacional , Humanos , Recém-Nascido , Estudos Longitudinais , Masculino , Pletismografia , Análise de Regressão , Gêmeos Dizigóticos , Gêmeos MonozigóticosRESUMO
BACKGROUND: Extrauterine growth restriction (EUGR) is common among very low birth weight (VLBW) infants and associated with poor neurodevelopmental outcomes. There are two types of EUGR definitions (cross-sectional and longitudinal) and many growth charts for monitoring postnatal growth. Aims of our study were 1) to compare the rate of small for gestational rate (SGA) and EUGR in a population of VLBW infants, both according to different growth charts (Fenton, INeS charts and Intergrowth-21) and different definitions; 2) to identify risk factors for EUGR. METHODS: This is a single centre retrospective observational study, including all VLBW infants born between January 2009 and December 2018. Anthropometric measures were obtained at birth and at discharge and presented as z-scores according to three growth charts (Fenton, INeS charts, Intergrowth-21). Maternal, clinical and nutritional data were retrieved from clinical records. RESULTS: 228 VLBW were included. Percentage of SGA did not change significantly according to the three different growth charts (Fenton 22.4%, INeS charts 22.8%, Intergrowth 28.2%, p 0.27). Prevalence of EUGR was significantly higher when INeS and Fenton charts were used, compared to Intergrowth charts regardless of EUGR-definition (cross sectional-EUGR: Fenton 33.5%, INeS charts 40.9%, Intergrowth-21 23.8%, p 0.001; longitudinal-EUGR (loss of 1SDS): Fenton 15%, INeS charts 20.4%, Intergrowth 4%, p <0.001). In our population a longer time to reach 100 ml/kg/day of enteral feeding increased of 18% the risk of longitudinal EUGR. Late onset sepsis and retinopathy of prematurity were associated with an increased risk of longitudinal EUGR, although not significantly, while having a preeclamptic mother was associated with a reduced risk. CONCLUSIONS: We confirmed a wide variability of EUGR rates when using different charts and definitions, highlighting that Intergrowth-21 charts identify less EUGR when compared to INeS and Fenton charts. Standardized criteria for defining EUGR are warranted in order to facilitate comparisons between studies and to improve the nutritional management of VLBW infants.
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Gráficos de Crescimento , Recém-Nascido de muito Baixo Peso , Recém-Nascido , Lactente , Feminino , Humanos , Estudos Transversais , Estudos Retrospectivos , Idade Gestacional , Peso ao NascerRESUMO
OBJECTIVE: To investigate whether monitoring of cerebral tissue oxygen saturation using near infrared spectroscopy in addition to routine monitoring combined with defined treatment guidelines during immediate transition and resuscitation increases survival without cerebral injury of premature infants compared with standard care alone. DESIGN: Multicentre, multinational, randomised controlled phase 3 trial. SETTING: 11 tertiary neonatal intensive care units in six countries in Europe and in Canada. PARTICIPANTS: 1121 pregnant women (<32 weeks' gestation) were screened prenatally. The primary outcome was analysed in 607 of 655 randomised preterm neonates: 304 neonates in the near infrared spectroscopy group and 303 in the control group. INTERVENTION: Preterm neonates were randomly assigned to either standard care (control group) or standard care plus monitoring of cerebral oxygen saturation with a dedicated treatment guideline (near infrared spectroscopy group) during immediate transition (first 15 minutes after birth) and resuscitation. MAIN OUTCOME MEASURE: The primary outcome, assessed using all cause mortality and serial cerebral ultrasonography, was a composite of survival without cerebral injury. Cerebral injury was defined as any intraventricular haemorrhage or cystic periventricular leukomalacia, or both, at term equivalent age or before discharge. RESULTS: Cerebral tissue oxygen saturation was similar in both groups. 252 (82.9%) out of 304 neonates (median gestational age 28.9 (interquartile range 26.9-30.6) weeks) in the near infrared spectroscopy group survived without cerebral injury compared with 238 (78.5%) out of 303 neonates (28.6 (26.6-30.6) weeks) in the control group (relative risk 1.06, 95% confidence interval 0.98 to 1.14). 28 neonates died (near infrared spectroscopy group 12 (4.0%) v control group 16 (5.3%): relative risk 0.75 (0.33 to 1.70). CONCLUSION: Monitoring of cerebral tissue oxygen saturation in combination with dedicated interventions in preterm neonates (<32 weeks' gestation) during immediate transition and resuscitation after birth did not result in substantially higher survival without cerebral injury compared with standard care alone. Survival without cerebral injury increased by 4.3% but was not statistically significant. TRIAL REGISTRATION: ClinicalTrials.gov NCT03166722.
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Lesões Encefálicas , Oxigênio , Recém-Nascido , Lactente , Humanos , Feminino , Gravidez , Encéfalo/diagnóstico por imagem , Saturação de Oxigênio , Recém-Nascido Prematuro , Idade GestacionalRESUMO
The effectiveness of "inadequate" intrapartum antibiotic prophylaxis (IAP administered < 4 h prior to delivery) in preventing early-onset sepsis (EOS) is debated. Italian prospective surveillance cohort data (2003-2022) were used to study the type and duration of IAP according to the timing of symptoms onset of group B streptococcus (GBS) and E. coli culture-confirmed EOS cases. IAP was defined "active" when the pathogen yielded in cultures was susceptible. We identified 263 EOS cases (GBS = 191; E. coli = 72). Among GBS EOS, 25% had received IAP (always active when beta-lactams were administered). Most IAP-exposed neonates with GBS were symptomatic at birth (67%) or remained asymptomatic (25%), regardless of IAP duration. Among E. coli EOS, 60% were IAP-exposed. However, IAP was active in only 8% of cases, and these newborns remained asymptomatic or presented with symptoms prior to 6 h of life. In contrast, most newborns exposed to an "inactive" IAP (52%) developed symptoms from 1 to >48 h of life. The key element to define IAP "adequate" seems the pathogen's antimicrobial susceptibility rather than its duration. Newborns exposed to an active antimicrobial (as frequently occurs with GBS infections), who remain asymptomatic in the first 6 h of life, are likely uninfected. Because E. coli isolates are often unsusceptible to beta-lactam antibiotics, IAP-exposed neonates frequently develop symptoms of EOS after birth, up to 48 h of life and beyond.
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BACKGROUND: An evidence-based Consensus on the treatment of undescended testis (UT) was recently published, recommending to perform orchidopexy between 6 and 12 months of age, or upon diagnosis and to avoid the use of hormones. In Italy, current practices on UT management are little known. Our aim was to describe the current management of UT in a cohort of Italian children in comparison with the Consensus guidelines. As management of retractile testis (RT) differs, RT cases were described separately. METHODS: Ours is a retrospective, multicenter descriptive study. An online questionnaire was filled in by 140 Italian Family Paediatricians (FP) from Associazione Culturale Pediatri (ACP), a national professional association of FP. The questionnaire requested information on all children with cryptorchidism born between 1/01/2004 and 1/01/2006. Data on 169 children were obtained. Analyses were descriptive. RESULTS: Overall 24% of children were diagnosed with RT, 76% with UT. Among the latter, cryptorchidism resolved spontaneously in 10% of cases at a mean age of 21.6 months. Overall 70% of UT cases underwent orchidopexy at a mean age of 22.8 months (SD 10.8, range 1.2-56.4), 13% of whom before 1 year. The intervention was performed by a paediatric surgeon in 90% of cases, with a success rate of 91%. Orchidopexy was the first line treatment in 82% of cases, while preceded by hormonal treatment in the remaining 18%. Hormonal treatment was used as first line therapy in 23% of UT cases with a reported success rate of 25%. Overall, 13 children did not undergo any intervention (mean age at last follow up 39.6 months). We analyzed the data from the 5 Italian Regions with the largest number of children enrolled and found a statistically significant regional difference in the use of hormonal therapy, and in the use of and age at orchidopexy. CONCLUSIONS: Our study showed an important delay in orchidopexy. A quarter of children with cryptorchidism was treated with hormonal therapy. In line with the Consensus guidelines, surgery was carried out by a paediatric surgeon in the majority of cases, with a high success rate.
Assuntos
Criptorquidismo/terapia , Fidelidade a Diretrizes/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Pré-Escolar , Gonadotropina Coriônica/uso terapêutico , Hormônio Liberador de Gonadotropina/uso terapêutico , Humanos , Lactente , Itália , Masculino , Pessoa de Meia-Idade , Orquidopexia/estatística & dados numéricos , Pediatria , Guias de Prática Clínica como Assunto , Estudos Retrospectivos , Inquéritos e Questionários , Resultado do TratamentoRESUMO
BACKGROUND: The neonatal period is the most vulnerable time in terms of a child's survival, with mortality during this period accounting for approximately half of the deaths before the age of 5 years. The Neonatal Essential Survival Technology (NEST) project is a program aiming to reduce mortality by improving the quality of neonatal care in sub-Saharan Africa. This study presents the evaluation of the first phase of the NEST intervention program at Saint Camille Hospital Ouagadougou (HOSCO), Burkina Faso, in terms of the reduction in neonatal mortality. METHODS: This is a retrospective analysis, based on "pre-intervention" data collected in 2015, and "post-intervention" data collected in 2018, including all infants admitted to the neonatal unit of HOSCO. The intervention period (2016 and 2017) comprised a structured quality improvement process conducted by a multidisciplinary working group that focused on improving infrastructure, equipment, training and use of clinical protocols, team working within the neonatal unit and with other hospital departments, and communication with referring healthcare facilities. Mortality data were compared pre- vs. post-intervention using a logistic regression model. RESULTS: The analysis included 1427 infants in the pre-intervention period, and 819 post-intervention. In both time periods, more than 75% of admissions were infants with low birth weight, and nearly 50% were very low birth weight. Post-intervention, while there was a decrease in overall admission, the proportion of multiple births increased from 20% to 24% (p = .01). The overall mortality rate was 44.9% (641/1427) pre-intervention, and 42.2% (346/819) post-intervention (OR 0.90, 95% confidence interval (CI) 0.76-1.07; p = .23). Adjusting for clinically relevant factors, the intervention was not associated with a change in overall mortality (OR 1.39, 95% CI 0.91-2.12; p = .13), but was associated with a reduced likelihood of mortality in outborn infants compared to inborn infants (OR 0.57, 95% CI 0.36-0.92; p = .02). CONCLUSIONS: The first phase of the NEST quality improvement program was associated with a decrease in mortality in outborn infants admitted to the neonatal unit at HOSCO. Long-term assessment is expected to provide a more comprehensive evaluation of the program in a low-income setting.