Correction: Anup C. Katheria. Neonatal Resuscitation with an Intact Cord: Current and Ongoing Trials. Children 2019, 6, 60.
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ABSTRACT:
SUBMITTER: Katheria AC
PROVIDER: S-EPMC6560425 | biostudies-literature | 2019 May
REPOSITORIES: biostudies-literature
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Correction: Anup C. Katheria. Neonatal Resuscitation with an Intact Cord: Current and Ongoing Trials. <i>Children</i> 2019, <i>6</i>, 60.
Children (Basel, Switzerland) 20190521 5
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Project description:Premature and full-term infants are at high risk of morbidities such as intraventricular hemorrhage or hypoxic-ischemic encephalopathy. The sickest infants at birth are the most likely to die and or develop intraventricular hemorrhage. Delayed cord clamping has been shown to reduce these morbidities, but is currently not provided to those infants that need immediate resuscitation. This review will discuss recently published and ongoing or planned clinical trials involving neonatal resuscitation while the newborn is still attached to the umbilical cord. We will discuss the implications on neonatal management and delivery room care should this method become standard practice. We will review previous and ongoing trials that provided respiratory support compared to no support. Lastly, we will discuss the implications of implementing routine resuscitation support outside of a research setting.
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Project description:ObjectiveTo assess whether providing ventilation during delayed cord clamping (V-DCC) increases placental transfusion compared with delayed cord clamping alone (DCC only).Study designInborn premature infants (230/7-316/7 weeks' gestational age) were randomized to receive at least 60 seconds of V-DCC (initial continuous positive airway pressure) with addition of positive pressure ventilation if needed) or without assisted ventilation (DCC only). For the DCC-only group, infants were dried and stimulated by gently rubbing the back if apneic. The primary outcome was the peak hematocrit in the first 24 hours of life. Delivery room outcomes were analyzed from video recordings and a data acquisition system. Hemodynamic measurements were performed with the use of functional echocardiography, near-infrared spectroscopy, and electrical cardiometry.ResultsThere was no difference in the primary outcome of peak hematocrit in the first 24 hours of life. The onset of breathing was similar between both groups (25 ± 20 and 27 ± 28 seconds, P = .627); however, infants receiving DCC received a greater duration of stimulation than V-DCC (41 ± 19 and 20 ± 21 seconds P = .002). There were no differences in delivery room interventions, early hemodynamics (cerebral oxygenation by near-infrared spectroscopy, cardiac output and stroke volume by electrical cardiometry, or superior vena cava flow by of functional echocardiography), or neonatal outcomes.ConclusionsV-DCC was feasible but did not lead to any measurable clinical improvements immediately after delivery or reduce subsequent neonatal morbidity. Caretakers should consider providing adequate stimulation before cord clamping.Trial registrationClinicalTrials.gov: NCT02231411.
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Project description:The optimal timing of cord clamping in asphyxia is not known. Our aims were to determine the effect of ventilation (sustained inflation-SI vs. positive pressure ventilation-V) with early (ECC) or delayed cord clamping (DCC) in asphyxiated near-term lambs. We hypothesized that SI with DCC improves gas exchange and hemodynamics in near-term lambs with asphyxial bradycardia. A total of 28 lambs were asphyxiated to a mean blood pressure of 22 mmHg. Lambs were randomized based on the timing of cord clamping (ECC-immediate, DCC-60 s) and mode of initial ventilation into five groups: ECC + V, ECC + SI, DCC, DCC + V and DCC + SI. The magnitude of placental transfusion was assessed using biotinylated RBC. Though an asphyxial bradycardia model, 2-3 lambs in each group were arrested. There was no difference in primary outcomes, the time to reach baseline carotid blood flow (CBF), HR ≥ 100 bpm or MBP ≥ 40 mmHg. SI reduced pulmonary (PBF) and umbilical venous (UV) blood flow without affecting CBF or umbilical arterial blood flow. A significant reduction in PBF with SI persisted for a few minutes after birth. In our model of perinatal asphyxia, an initial SI breath increased airway pressure, and reduced PBF and UV return with an intact cord. Further clinical studies evaluating the timing of cord clamping and ventilation strategy in asphyxiated infants are warranted.
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Project description:Background: Preterm newborns receiving briefly delayed cord clamping or cord milking at birth have better neonatal outcomes. However, the time frame in which both these procedures are performed (< 60 s of life) is too short to explore the possible beneficial effects on early infant postnatal adaptation and outcomes of a prolonged transfusion strategy associated with neonatal respiration. Methods and Design: We have designed a randomized, multicenter, controlled two-phase study: phase 1 to assess the feasibility of carrying out the protocol in a large randomized trial, and phase 2 to assess the efficacy of bedside assistance with intact placental circulation for 3 min in comparison to cord milking to improve outcome in the neonatal period; we present here the feasibility and safety phase of the study. Outcomes included feasibility (recruitment rate of two patients per month, compliance with the trial interventions, completeness of data collection, >90% of infants receiving echographic assessments in the first 24 h) and safety variables (5 min Apgar score, delivery room intubation rate, CRIB II score, admission temperature, maximum hemoglobin concentration and hematocrit in the first 24 h and maximum serum bilirubin value) in the two study groups. We also evaluated the same safety variables in infants delivered during the study period but not recruited. Results: A total of 40 infants were enrolled. In all cases the protocol was completed and all feasibility outcomes were reached. Infants assisted with an intact placental circulation have a higher 5 min Apgar score but their admission temperature was lower than milked infants. Delivery room intubation rate, CRIB II score and peak serum bilirubin value were comparable in both groups. Infants who were not subjected to a placental transfusion strategy (excluded patients) had a higher delivery room intubation rate with respect to both study groups. Conclusion: Delaying cord clamping until 3 min of life was challenging but feasible and appeared to be safe. However, admission temperature must be strictly monitored and a more efficacious warming system could be implemented to prevent hypothermia during the procedure. Trial Registration: Clinicaltrials,gov NCT02671305 (date of registration: 26 JAN 2016). https://clinicaltrials.gov/ct2/show/NCT02671305.
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Project description:BackgroundElucidation of mechanisms regulating bone metastasis has progressed significantly in recent years and this has translated to many new therapeutic options for patients with bone metastatic cancers. However, the rapid rate of progress in both the basic science literature and therapies undergoing clinical trials makes staying abreast with current developments challenging. This review seeks to provide an update on the current state of the science in bone metastasis research and give a snap shot of therapies in clinical trials for bone metastatic cancer.Main bodyBone metastasis represents a difficult to treat clinical scenario due to pain, increased fracture risk, decreased quality of life and diminished overall survival outcomes. Multiple types of cancer have the specific ability to home to the bone microenvironment and cause metastatic lesions. This osteotropism was first described by Stephen Paget nearly 100 years ago as the 'seed and soil' hypothesis. Once cancer cells arrive at the bone they encounter a variety of cells native to the bone microenvironment which contribute to the establishment of bone metastatic lesions. In the first part of this review, the 'seed and soil' hypothesis is revisited while emphasizing recent developments in understanding the impact of native bone microenvironment cells on the metastatic process. Next, approved therapies for treating bone metastasis at the systemic level as well as those that target the bone microenvironment are discussed and current National Comprehensive Cancer Network (NCCN) guidelines relating to treatment of bone metastases are summarized. Finally, all open interventional clinical trials for therapies relating to treatment of bone metastasis have been complied and categorized.ConclusionUnderstanding the recent advancements in bone metastasis research is important for continued development of novel bone targeted therapies. The plethora of ongoing clinical trials will hopefully translate into improved treatments options for patients suffering from bone metastatic cancers.
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Project description:Approximately 1 in 10 newborns will require basic resuscitation interventions at birth. Some infants progress to require more advanced measures including the provision of positive pressure ventilation, chest compressions, intubation and administration of volume/cardiac medications. Although advanced resuscitation is infrequent, it is crucial that personnel adequately trained in these techniques are available to provide such resuscitative measures. In 2000, Louis Halmalek et al. called for a "New Paradigm in Pediatric Medical Education: Teaching Neonatal Resuscitation in a Simulated Delivery Room Environment." This was one of the first articles to highlight simulation as a method of teaching newborn resuscitation. The last decades have seen an exponential growth in the area of simulation in newborn care, in particular in newborn resuscitation and stabilization. Simulation is best defined as an instructional strategy "used to replace or amplify real experiences with guided experiences that evoke or replicate substantial aspects of the real world in a fully interactive manner." Simulation training has now become an important point of how we structure training and deliver improved healthcare to patients. Some of the key aspects of simulation training include feedback, deliberate practice, outcome measurement, retention of skills and curriculum integration. The term "Train to win" is often used in sporting parlance to define how great teams succeed. The major difference between sports teams is that generally their game day comes once a week, whereas in newborn resuscitation every day is potentially "game day." In this review we aim to summarize the current evidence on the use of simulation based education and training in neonatal resuscitation, with particular emphasis on the evidence supporting its effectiveness. We will also highlight recent advances in the development of simulation based medical education in the context of newborn resuscitation to ensure we "train to win."
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