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BACKGROUND: Cor triatriatum dexter (CTD) is an extremely rare pathology, with an incidence of < 0.4%. Its main characteristic is a partitioning of the right atrium by the persistence of the embryonic valve of the right sinus venosus. CLINICAL CASE: In this report, we describe the case of a 7-day-old newborn who presented with persistent cyanosis associated with feeding and crying. The diagnosis of CTD was made after an echocardiogram and confirmed using cardiac magnetic resonance imaging. The patient underwent successful surgery on day 14 with a favorable outcome and without complications. CONCLUSION: The importance of our case lies in the identification of rare heart disease as a cause of cyanosis and desaturation in a neonatal patient in the first days of life who did not present signs of heart failure and whose condition improved with supplemental oxygen. We also demonstrate that early diagnosis with echocardiography and surgical resolution resulted in clear clinical improvement and avoided future complications.
INTRODUCCIÓN: El cor triatriatum dexter es una cardiopatía muy rara, caracterizada por la división parcial del atrio derecho en dos cavidades por la persistencia de una membrana que embriológicamente representa la valva derecha del seno venoso. CASO CLÍNICO: En este reporte de caso, presentamos el caso de un neonato en su día 7 de vida que acude a valoración por presentar desaturación persistente con cianosis al llanto. El diagnóstico se realizó con ecocardiograma posterior al cual se decidió la resección quirúrgica de la membrana, procedimiento que fue llevado a cabo el día 14 de vida con éxito sin complicaciones. CONCLUSIONES: La importancia de este caso clínico radica en la identificación de una cardiopatía rara como causa de cianosis y desaturación en un paciente en etapa neonatal, el cual no presentaba datos de compromiso hemodinámico. También se muestra como un diagnóstico y tratamiento quirúrgico oportuno permitieron una resolución de los síntomas sin complicaciones futuras.
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Corazón Triatrial , Cianosis , Ecocardiografía , Imagen por Resonancia Magnética , Humanos , Corazón Triatrial/diagnóstico , Corazón Triatrial/cirugía , Corazón Triatrial/complicaciones , Cianosis/etiología , Recién Nacido , Masculino , FemeninoRESUMEN
Available evidence of oral sensorimotor interventions for small neonates is not strong. Evidence of interventions for sick term neonates is largely lacking. Studies are limited by risk of bias and inconsistency. Evidence of interventions relying on a single stimulation technique only appears to be low to very low. Ongoing research is required.Contribution: We describe a five-component neonatal swallowing and breastfeeding intervention programme embedded in the practice of kangaroo mother care (KMC). Drawing on oropharyngeal physiology, neonatology, neurodevelopmental care, breastfeeding- and KMC science, the programme is the product of collaboration between a speech-language therapist and a medical doctor, and their team. Its implementation is dependent on coaching mothers and the neonatal care team. Researchers are invited to determine outcomes of the programme.
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Lactancia Materna , Método Madre-Canguro , Humanos , Método Madre-Canguro/métodos , Recién Nacido , Deglución , Femenino , Trastornos de Deglución/terapia , Patología del Habla y Lenguaje/métodosRESUMEN
Vancomycin has a narrow therapeutic window and a high inter-individual pharmacokinetic variability, especially in neonates with fast maturational and pathophysiological changes, that needs individualized dosing. Physiologically based pharmacokinetic (PBPK) model and population pharmacokinetic (PopPK) model are both useful tools in model-informed precision dosing, while the former is under research in application of vancomycin in neonates. This study aimed to develop a PBPK model of vancomycin in adult and pediatric population, and compared it with published PopPK model (priori or Bayesian method) in predicting vancomycin concentration in 230 neonatal patients (postmenstrual age, PMA, 25-45 weeks). The developed PBPK model showed a good fit between predictions and observations. PBPK model and PopPK model are complementary in different clinical scenarios of vancomycin application. The physiological-change description of PBPK model showed a superior advantage in initial dosing optimization. As for subsequent dose optimization, PopPK Bayesian forecasting performed better than the PBPK estimation in neonates. However, initial precision dosing tools for early neonates (with PMA < 36 weeks) still need further exploitation.
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Background: The European Foundation for the Care of Newborn Infants (EFCNI) has promoted the importance of parental involvement in the care of children. Objective: The study aimed to examine how the time required by parents to achieve autonomy in the care of their very low-birth weight newborn infants was modified during the implementation of a training program. Methods: This was an observational prospective study in the context of a quality improvement initiative. The Cuídame (meaning "Take Care of Me" in English) program was aimed at achieving parental autonomy. It was implemented over 2 periods: period 1, from September 1, 2020, to June 15, 2021; and period 2, from July 15, 2021, to May 31, 2022. The days required by parents to achieve autonomy in several areas of care were collected from the electronic health system. Results: A total of 54 and 43 families with newborn infants were recruited in periods 1 and 2, respectively. Less time was required to acheive autonomy in period 2 for participation in clinical rounds (median 10.5, IQR 5-20 vs 7, IQR 4-10.5 d; P<.001), feeding (median 53.5, IQR 34-68 vs 44.5, IQR 37-62 d; P=.049), and observation of neurobehavior (median 18, IQR 9-33 vs 11, IQR 7-16 d; P=.049). More time was required to achieve autonomy for kangaroo mother care (median 14, IQR 7-23 vs 21, IQR 10-31 d; P=.02), diaper change (median 9.5, IQR 4-20 vs 14.5, IQR 9-32 d; P=.04), and infection prevention (median 1, IQR 1-2 vs 6, IQR 3-12; P<.001). Conclusions: Parents required less time to achieve autonomy for participation in clinical rounds, feeding, and observation of neurobehavior during the implementation of the training program. Nevertheless, they required more time to achieve autonomy for kangaroo mother care, diaper change, and infection prevention.
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Sepsis is a common disease with high morbidity and mortality among newborns in intensive care units world-wide. Gram-negative bacillary bacteria are the major source of infection in neonates. Gentamicin is the most widely used aminoglycoside antibiotic in empiric therapy against early-onset sepsis. However, therapy failure may result due to various factors. The purpose of this study was to identify predictors of gentamicin therapy failure in neonates with sepsis. This was a prospective cross-sectional study at the Neonatal Intensive Care Unit at Windhoek Central Hospital over a period of 5 months in 2019. Neonates received intravenous gentamicin 5 mg/kg/24 h in combination with either benzylpenicillin 100 000 IU/kg/12 h or ampicillin 50 mg/kg/8 h. Logistic regression modeling was performed to determine the predictors of treatment outcomes. 36% of the 50 neonates were classified as having gentamicin treatment failure. Increasing treatment duration by 1 day resulted in odds of treatment failure increasing from 1.0 to 2.41. Similarly, one unit increase in CRP increases odds of gentamicin treatment failure by 49%. The 1 kg increase in birthweight reduces the log odds of treatment failure by 6.848, resulting in 99.9% decrease in the odds of treatment failure. One unit increase in WBC reduces odds of gentamicin treatment failure by 27%. Estimates of significant predictors of treatment failure were precise, yielding odds ratios that were within 95% confidence interval. This study identified the following as predictors of gentamicin therapy failure in neonates: prolonged duration of treatment, elevated C-reactive protein, low birthweight, and low white blood cell count.
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Antibacterianos , Gentamicinas , Unidades de Cuidado Intensivo Neonatal , Insuficiencia del Tratamiento , Humanos , Gentamicinas/uso terapéutico , Gentamicinas/administración & dosificación , Recién Nacido , Antibacterianos/uso terapéutico , Antibacterianos/administración & dosificación , Estudios Transversales , Estudios Prospectivos , Femenino , Masculino , Unidades de Cuidado Intensivo Neonatal/estadística & datos numéricos , Sepsis Neonatal/tratamiento farmacológico , Proteína C-Reactiva/análisis , Sepsis/tratamiento farmacológico , Sepsis/mortalidad , Peso al Nacer , Ampicilina/uso terapéutico , Ampicilina/administración & dosificaciónRESUMEN
AIM: To establish reference ranges of peripheral-muscle regional oxygen saturation (prSO2) and peripheral fractional tissue oxygen extraction (pFTOE) during the first 15 min after birth in stable term neonates. METHODS: Secondary outcome parameters of prospective observational studies in healthy term neonates delivered by Caesarean section were analysed. prSO2 was measured on the right forearm using the INVOS 5100C monitor. pFTOE was calculated out of prSO2 and arterial oxygen saturation (SpO2). Centile charts (10th-90th) of prSO2 and pFTOE were defined during the first 15 min after birth. RESULTS: Three-hundred-five term neonates with a mean gestational age and birth weight of 39.0 ± 0.9 weeks and 3321 ± 454 g, respectively, were included. The 50th centiles of prSO2 were 39% (minute two), 52% (minute five), 71% (minute 10), and 73% (minute 15). The 50th centiles of pFTOE were 0.529 (minute two), 0.378 (minute five), 0.237 (minute 10), and 0.231 (minute 15). CONCLUSION: Reference ranges of prSO2 and pFTOE were established for term neonates delivered by Caesarean section during the immediate transition after birth. These reference ranges increase knowledge of physiological processes taking place immediately after birth and are necessary for possible future clinical applications.
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Objective: To examine whether variation of regional cerebral oxygen saturation (rScO2) within three days after delivery predicts development of brain injury (intraventricular/cerebellar hemorrhage or white matter injury) in preterm infants. Study design: A prospective study of neonates <32 weeks gestational age with normal cranial ultrasound admitted between 2018 and 2022. All received rScO2 monitoring with near-infrared spectroscopy at admission up to 72â h of life. To assess brain injury a magnetic resonance imaging was performed at term-equivalent age. We assessed the association between rScO2 variability (short-term average real variability, rScO2ARV, and standard deviation, rScO2SD), mean rScO2 (rScO2MEAN), and percentage of time rScO2 spent below 60% (rScO2TIME<60%) during the first 72â h of life and brain injury. Results: The median [IQR] time from birth to brain imaging was 68 [59-79] days. Of 81 neonates, 49 had some form of brain injury. Compared to neonates without injury, in those with injury rScO2ARV was higher during the first 24â h (P = 0.026); rScO2SD was higher at 24 and 72â h (P = 0.029 and P = 0.030, respectively), rScO2MEAN was lower at 48â h (P = 0.042), and rScO2TIME<60% was longer at 24, 48, and 72â h (P = 0.050, P = 0.041, and P = 0.009, respectively). Similar results were observed in multivariable logistic regression. Although not all results were statistically significant, increased rScO2 variability (rScO2ARV and rScO2SD) and lower mean values of rScO2 were associated with increased likelihood of brain injury. Conclusions: In preterm infants increased aberration of rScO2 in early postdelivery period was associated with an increased likelihood of brain injury diagnosis at term-equivalent age.
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Neuroimaging research on functional connectivity can provide valuable information on the developmental differentiation of the infant cerebral cortex into its functional areas. We examined healthy neonates to comprehensively map brain functional connectivity using a combination of local measures that uniquely capture the rich spatial structure of cerebral cortex functional connections. Optimal functional MRI scans were obtained in 61 neonates. Local functional connectivity maps were based on Iso-Distance Average Correlation (IDAC) measures. Single distance maps and maps combining three distinct IDAC measures were used to assess different levels of cortical area functional differentiation. A set of brain areas showed higher connectivity than the rest of the brain parenchyma in each local distance map. These areas were consistent with those supporting basic aspects of the neonatal repertoire of adaptive behaviors and included the sensorimotor, auditory and visual cortices, the frontal operculum/anterior insula (relevant for sucking, swallowing and the sense of taste), paracentral lobule (processing anal and urethral sphincter activity), default mode network (relevant for self-awareness), and limbic-emotional structures such as the anterior cingulate cortex, amygdala and hippocampus. However, the results also indicate that brain areas presumed to be actively developing may not necessarily be mature. In fact, combined distance, second-level maps confirmed that the functional differentiation of the cerebral cortex into functional areas in neonates is far from complete. Our results provide a more comprehensive understanding of the developing brain systems, while also highlighting the substantial developmental journey that the neonatal brain must undergo to reach adulthood.
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Thrombocytopenia is common in preterm neonates and can be associated with hemorrhage. Most platelet transfusions are prophylactic. Previously, higher platelet-count thresholds were recommended for neonates, but this recommendation has been questioned in recent studies. In the PlaNeT2 trial, mortality and serious bleeding were more frequent in neonates with the highest platelet-count threshold than in others. Following this trial, we changed our platelet transfusion practice by lowering the platelet-count threshold for prophylactic transfusion from 50,000 to 25,000/mm3. We conducted a before-after retrospective cohort study to quantify the frequency of platelet transfusions and assess the new protocol by analyzing death and serious hemorrhage events. This retrospective monocentric study included neonates born before 37 weeks of gestation with platelet count < 150,000/mm3 during the 2 years preceding the new platelet transfusion protocol (high prophylactic transfusion threshold, 50,000/mm3) and during the 2 years after the new platelet transfusion protocol (low prophylactic transfusion threshold, 25,000/mm3). The primary outcome was the proportion of neonates receiving at least one platelet transfusion in both groups. We also compared the proportion of deaths and severe hemorrhage events. A total of 707 neonates with thrombocytopenia were identified. In the high-threshold group, 99/360 (27.5%) received at least one platelet transfusion as compared with 56/347 (16.1%) in the low-threshold group (p < 0.001). The groups did not differ in proportion of deaths or severe hemorrhage events. CONCLUSIONS: A reduced platelet-count threshold for transfusion allowed for a significant reduction in the number of platelet transfusions without increasing severe hemorrhage events. WHAT IS KNOWN: ⢠A recent randomized trial suggested that restrictive platelet-count thresholds for platelet transfusion could be beneficial for preterm neonates. WHAT IS NEW: ⢠On lowering the platelet-count threshold for transfusion from 50,000 to 25,000/mm3, the number of transfusions significantly decreased without increasing severe hemorrhage events in a neonatal intensive care unit.
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Fidgety movements provide early information about a potential development of cerebral palsy in preterm neonates. The aim was to assess differences in the combined outcome of mortality and fidgety movements defined as normal or pathological in very preterm neonates according to the group allocation in the randomised-controlled multicentre COSGOD III trial. Preterm neonates of two centres participating in the COSGOD III trial, whose fidgety movements were assessed as normal or pathological at six to 20 weeks of corrected age, were analysed. In the COSGOD III trial cerebral oxygen saturation (crSO2) was measured by near-infrared spectroscopy (NIRS) during postnatal transition and guided resuscitation in preterm neonates randomised to the NIRS-group, whereby medical support was according routine, as it was also in the control group. Fidgety movements were classified in normal or abnormal/absent at six to 20 weeks of corrected age. Mortality and fidgety movements of preterm neonates allocated to the NIRS-group were compared to the control-group. Normal outcome was defined as survival with normal fidgety movements. One-hundred-seventy-one preterm neonates were included (NIRS-group n = 82; control-group n = 89) with a median gestational age of 29.4 (27.4-30.4) and 28.7 (26.7-31.0) weeks in the NIRS-group and the control-group, respectively. There were no differences in the combined outcome between the two groups: 90.2% of the neonates in the NIRS-group and 89.9% in the control-group survived with normal outcome (relative risk [95% CI]; 0.96 [0.31-2.62]).Conclusions: In the present cohort of preterm neonates, monitoring of crSO2 and dedicated interventions in addition to routine care during transition period after birth did not show an impact on mortality and fidgety movements defined as normal or pathological at six to 20 weeks corrected age. What is Known ⢠Fidgety movements display early spontaneous motoric pattern and may provide early information about a potential development of cerebral palsy in preterm neonates. What is New ⢠This retrospective observational study of the randomised-controlled multicentre COSGOD III trial is the first study investigating the potential influence of cerebral oxygenation guided resuscitation during postnatal transition period on combined outcome of mortality and fidgety movements up to 20 weeks of corrected age in very preterm neonates. ⢠This study adds to the growing interest of assessing cerebral oxygenation, that monitoring of cerebral oxygen saturation and dedicated interventions during postnatal transition period according to the COSGOD III trial has no significant influence on mortality and fidgety movements defined as normal or pathological in very preterm neonates.
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Introduction and importance: Brain abscess (BA) is a pyogenic infection of the brain parenchyma caused by various organisms. Multiple BAs are uncommon in neonates, and Candida albicans as a causative agent is very rare. If left untreated, BAs are invariably fatal. Early diagnosis, prompt surgical intervention, simultaneous eradication of the primary source, and high-dose intravenous antibiotics decrease the incidence of morbidity and mortality. Case presentation: A 20-day-old newborn, delivered normally at term with a full APGAR score, presented with a 5-day history of fever, decreased activity, jaundice, and seizures. Imaging identified multiple cerebral cysts, diagnosed as multiple cerebral abscesses. Treatment involved intraoperative USG-guided burr-hole drainage, followed by a 6-week antifungal therapy course. C. albicans was found to be the causative organism following microscopic examination and culture of the pus. Clinical discussion: This literature highlights the rarity of fungal involvement in multiple cerebral abscesses in neonates. Managing such cases is very challenging, as the presentation may mimic bacterial infections. The importance of considering fungi as a causative agent in treatment decisions is crucial. Conclusion: Multiple BAs of fungal origin are extremely rare. Early detection and management of cases can reduce mortality among neonates.
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Objectives: We analyzed the impact of postoperative necrotizing enterocolitis (NEC) after cardiac surgery in neonatal age on neurodevelopmental (ND) outcome at 1 year of age. Methods: Using data from the Swiss Neurodevelopmental Outcome Registry for Children with Congenital Heart Disease (ORCHID), we analyzed perioperative variables including postoperative NEC (Bell's stage ≥2) and 1-year ND outcome (Bayley III). Results: The included patients (n = 101) had congenital heart disease (CHD), categorized as follows: 77 underwent biventricular repair for CHD with two functional chambers, 22 underwent staged palliation until the Fontan procedure for CHD with single ventricle physiology (n = 22), or 4 underwent single ventricle palliation or biventricular repair for borderline CHD (n = 4). Neonatal cardiopulmonary bypass (CBP) surgery was performed at a median age (IQR) of 8 (6) days. NEC occurred in 16 patients. Intensive care unit (ICU) length of stay (LOS) and the total duration of the hospitalization were longer in children with NEC than those in others (14 with vs. 8 days without NEC, p < 0.05; 49 with vs. 32 days without NEC, p < 0.05). The Bayley III scores of the analyzed patients determined at an age of 11.5 ± 1.5 months showed cognitive (CCS) (102.2 ± 15.0) and language scores (LCS) (93.8 ± 13.1) in the normal range and motor composite scores (MCS) (88.7 ± 15.9) in the low-normal range. After adjusting for socioeconomic status and CHD type, patients with NEC had lower CCS scores [ß = -11.2 (SE 5.6), p = 0.049]. Using a cumulative risk score including NEC, we found a higher risk score to be associated with both lower CCS [ß = -2.8 (SE 1.3), p = 0.030] and lower MCS [ßâ =â -3.20 (SE 1.3), p = 0.016]. Conclusions: Postoperative NEC is associated with longer ICU and hospital LOS and contributes together with other complications to impaired ND outcome at 1 year of age. In the future, national and international patient registries may provide the opportunity to analyze large cohorts and better identify the impact of modifiable perioperative risk factors on ND outcome. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT05996211.
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BACKGROUND: Necrotizing enterocolitis is the most severe life-threatening acquired gastrointestinal disorder among preterm neonates. We describe here an outbreak of Clostridium butyricum-related necrotizing enterocolitis in preterm neonates that occurred in three different neonatal centres, in southeast France. METHODS: We defined a confirmed case of C. butyricum-related necrotizing enterocolitis in preterm neonates by the presence of clinical signs according to modified Bell criteria and C. butyricum identified from stool samples using real-time polymerase chain reaction or culture. A phylogenetic analysis of the isolated strains by whole-genome sequencing was also performed. RESULTS: Between 5th and 27th January 2022, we identified 10 confirmed cases of C. butyricum-related necrotizing enterocolitis, including five from Neonatal Centre 1, four from Neonatal Centre 2, and one from Neonatal Centre 3. The attack rate of necrotizing enterocolitis in Neonatal Centre 1 was 7.1% (5/70). The positivity rate of C. butyricum detected from stool samples was higher during the outbreak period (37/276; 13.4%) than outside this period (7/369; 1.9%), while systematic screening was maintained (P<0.001). Phylogenetic analysis showed a clonality between strains inside four clusters. Two clusters included neonates hospitalized in different neonatal centres, suggesting the transmission of C. butyricum strains during the transfer of neonates between neonatal centres. CONCLUSIONS: This outbreak of C. butyricum-related necrotizing enterocolitis confirms a cross-transmission between preterm neonates, including twin or triplet siblings, and involving necrotizing enterocolitis cases together with asymptomatic carriers. After three months of follow-up, no further cases were identified following the implementation of contact precautions with sporicidal agents.
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Objectives: To explore risk factors for Stage-III necrotizing enterocolitis (NEC-III) in preterm neonates. Methods: This was a retrospective case-control study of neonates born <33 weeks gestational age (GA) who were admitted to a tertiary neonatal intensive care unit, between 2015 and 2018. NEC-III cases were compared with Stage-II NEC (NEC-II) and non-NEC controls. Two to four non-NEC controls were matched by GA ± 1 week and date of birth ± 3 months, to one NEC-III case. Univariate and multivariate analyses were used to examine risk factors for NEC-III. Results: Of 1360 neonates born <33 weeks, 71 (5.2%) had NEC-II and above, with 46% being NEC-III. Mean age of onset of NEC-III was 13.7 days versus 23.9 days for NEC-II (p = 0.01). Neonates with NEC-III were of lower GA (NEC-III 25.4 weeks, NEC-II 27.3 weeks, and non-NEC 26 weeks; p = 0.0008) and had higher Score for Neonatal Acute Physiology Perinatal Extension-II scores (NEC-III 47.5, NEC-II 28.4 and non-NEC 37, p = 0.003). Multivariate analysis showed duration of umbilical arterial catheter (UAC) >5 days was significantly associated with the development of NEC-III with adjusted odds ratio (AOR) 3.8; 95% confidence interval (CI) (1.05-13.66) for NEC-III versus non-NEC and AOR 5.57; 95% CI (1.65-18.73), p = 0.006 for NEC-III versus NEC-II. Rupture of membranes (ROM) >1 week was associated with NEC-III (AOR 6.93; 95% CI [1.56-30.69] vs. non-NEC and AOR 11.74; 95% CI [1.14-120.34] vs. NEC-II). Conclusion: The increased association of NEC-III with duration of UAC and ROM could be further examined in prospective studies, and an upper limit for UAC duration could be considered in NEC prevention bundles.
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Neonatal respiratory distress syndrome (NRDS) is a significant cause of morbidity and mortality in preterm infants due to insufficient surfactant production in the lungs. This case report explores the effect of physical rehabilitation on oro-motor stimulation, manual airway clearance, positioning, and tactile stimulation (PROMPT) approach on a preterm neonate with NRDS. The report details the pre-natal, natal, and post-natal history of the patient, including maternal health, pregnancy complications, delivery specifics, initial clinical presentation, and subsequent management. Standard treatments such as exogenous surfactant administration and respiratory support were complemented with PROMPT techniques. The outcomes demonstrate the potential benefits of incorporating physical rehabilitation in the management of NRDS, highlighting improvements in respiratory function and overall clinical stability. This case underscores the importance of multidisciplinary approaches in enhancing the care and prognosis of neonates with NRDS.
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Modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) is a novel strategy for peripheral nerve block in the abdomen. Its usefulness has been highlighted in adults, but no literature is currently available regarding its efficacy in infants. This report describes the cases of a one-day-old neonate in open abdominal surgery and a one-month-old infant in laparoscopic surgery who received M-TAPA. The postoperative condition of the infants was assessed through a neonate pain scale and the Face, Legs, Activity, Cry, and Consolability behavioral scale, respectively; both scales remained at 0 until discharge. Despite the need for special attention, M-TAPA may provide effective analgesia in neonatal and infant abdominal surgery in addition to adult cases, and its indications should be considered.
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When planning pediatric clinical trials, optimizing the sample size of neonates/infants is essential because it is difficult to enroll these subjects. In this simulation study, we evaluated the sample size of neonates/infants using a model-based optimal approach for identifying their pharmacokinetics for cefiderocol. We assessed the usefulness of data for estimation performance (accuracy and variance of parameter estimation) from adults and the impact of data from very young subjects, including preterm neonates. Stochastic simulation and estimation were utilized to assess the impact of sample size allocation for age categories in estimation performance for population pharmacokinetic parameters in pediatrics. The inclusion of adult pharmacokinetic information improved the estimation performance of population pharmacokinetic parameters as the coefficient of variation (CV) range of parameter estimation decreased from 4.9%-593.7% to 2.3%-17.3%. When sample size allocation was based on the age groups of gestational age and postnatal age, the data showed 15 neonates/infants would be necessary to appropriately estimate pediatric pharmacokinetic parameters (<20%CV). By using the postmenstrual age (PMA), which is theoretically considered to be associated with the maturation of organs, the number of neonates/infants required for appropriate parameter estimation could be reduced to seven (one and six with <32 and >32 weeks PMA, respectively) to nine (three and six with <37 and >37 weeks PMA, respectively) subjects. The model-based optimal design approach allowed efficient evaluation of the sample size of neonates/infants for estimation of pediatric pharmacokinetic parameters. This approach to assessment should be useful when designing pediatric clinical trials, especially those including young children.
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Antibacterianos , Cefiderocol , Cefalosporinas , Humanos , Recién Nacido , Cefalosporinas/farmacocinética , Tamaño de la Muestra , Lactante , Antibacterianos/farmacocinética , Antibacterianos/administración & dosificación , Modelos Biológicos , Ensayos Clínicos como Asunto , Simulación por Computador , Adulto , Edad Gestacional , Factores de EdadRESUMEN
BACKGROUND: The aim of this study was to investigate the epidemiological characteristics and antibiotic resistance patterns of Ureaplasma urealyticum (UU) infection among women and children in southwest China. METHODS: A total of 8,934 specimens, including urogenital swabs and throat swabs were analyzed in this study. All samples were tested using RNA-based Simultaneous Amplification and Testing (SAT) methods. Culture and drug susceptibility tests were performed on UU positive patients. RESULTS: Among the 8,934 patients, the overall positive rate for UU was 47.92%, with a higher prevalence observed among women of reproductive age and neonates. The majority of UU positive outpatients were women of reproductive age (88.03%), while the majority of UU positive inpatients were neonates (93.99%). Overall, hospitalization rates due to UU infection were significantly higher in neonates than in women. Further analysis among neonatal inpatients revealed a higher incidence of preterm birth and low birth weight in UU positive inpatients (52.75% and 3.65%, respectively) than in UU negative inpatients (44.64% and 2.89%, respectively), especially in very preterm and extremely preterm neonates. Moreover, the incidence rate of bronchopulmonary dysplasia (BPD) among hospitalized neonatal patients was significantly higher in the UU positive group (6.89%) than in the UU negative group (4.18%). The drug susceptibility tests of UU in the neonatology, gynecology and obstetrics departments exhibited consistent sensitivity patterns to antibiotics, with high sensitivity to tetracyclines and macrolides, and low sensitivity to fluoroquinolones. Notably, UU samples collected from the neonatology department exhibited significantly higher sensitivity to azithromycin and erythromycin (93.8% and 92.9%, respectively) than those collected from the gynecology and obstetrics departments. CONCLUSIONS: This study enhances our understanding of the current epidemiological characteristics and antibiotic resistance patterns of UU infection among women and children in southwest China. These findings can aid in the development of more effective intervention, prevention and treatment strategies for UU infection.
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Antibacterianos , Farmacorresistencia Bacteriana , Pruebas de Sensibilidad Microbiana , Infecciones por Ureaplasma , Ureaplasma urealyticum , Humanos , Infecciones por Ureaplasma/epidemiología , Infecciones por Ureaplasma/microbiología , Infecciones por Ureaplasma/tratamiento farmacológico , Ureaplasma urealyticum/efectos de los fármacos , Ureaplasma urealyticum/aislamiento & purificación , Ureaplasma urealyticum/genética , Femenino , China/epidemiología , Recién Nacido , Antibacterianos/farmacología , Adulto , Masculino , Adolescente , Lactante , Persona de Mediana Edad , Adulto Joven , Preescolar , Niño , PrevalenciaRESUMEN
INTRODUCTION: Among premature infants, the incidence of inguinal hernias (IH) has been reported to be as high as 10-30%. We performed this study to characterize the association between individual and systemic variables that may affect diagnosis to definitive operative repair of the premature neonatal IH in the outpatient setting. METHODS: A single center cohort retrospective review analyzing IH repair in the premature neonatal (<37 GA) population was performed. Data was collected between 2013 and 2022. The cohort was defined as patients who underwent repair before the age of 1 and excluded patients with major medical comorbidities or underwent simultaneous major abdominal surgeries. RESULTS: Of the 836 premature neonates who underwent IH repair, the majority (73%) were repaired electively. Patients were characterized into risk cohorts a-priori. High-risk patients (HR, n = 43) were more likely to have Government insurance (67%). There was a significant difference in HR patient time to surgery between Government versus Commercial insurance, 10.6 versus 4.7 days, respectively (95% CI -11.09 to -0.4396, p = 0.0345). HR patients were also seen more frequently (clinic or emergency department) prior to operative repair (2.51 vs 1.72 95% CI -1.296% to -0.289%, p = 0.0021). A multivariate linear regression model demonstrated that risk class (p = 0.0244), touches (p < 0.0001), GA (p < 0.001), and prior authorization (p < 0.0001) were significantly associated with time to hernia repair. CONCLUSIONS: Systemic variables such as insurance type may increase average wait time for elective outpatient IH repair. This increase in wait time is associated with an increased number of healthcare visits. Therefore, timely access to surgical care prevents potential harm and may decrease health system burden. TYPE OF STUDY: Retrospective comparative study/cohort study. LEVEL OF EVIDENCE: III.
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BACKGROUND: Devices measuring the macronutrient content of human milk are commonly used to assist with clinical decision-making. It is unknown if these devices accurately measure protein content in donor human milk (DHM). Our objective is to quantify the nitrogen sources and protein content in commercial DHM. METHODS: The total nitrogen content (Dumas method) and nonprotein nitrogen content (Kjeldahl method) was measured in triplicate from six commercial DHM samples with protein content noted on the labels. In addition, the amino acid content was measured in 15 commercial DHM samples and protein content in each sample was calculated. The calculated protein content for each DHM sample was compared for consistency. RESULTS: The nonprotein nitrogen content in DHM was consistently higher (0.33 ± 0.05 g/g) than previous reports, leading to overreporting of protein content on DHM labels by a median value of 0.15 g/dl (range 0.02-0.23 g/dl). Similarly, calculation of the protein content from the total nitrogen content with an assumption of 20% (grams per gram) nonprotein nitrogen consistently overrepresented the protein content as determined from the amino acid profile for DHM. CONCLUSION: Common methods for assessing the macronutrient content of human milk may overestimate the protein content of DHM.