Effectiveness of a phone-based nurse monitoring assessment and intervention for chemotherapy-related toxicity: A randomized multicenter trial

PurposeAnticancer treatment-related toxicities can impact morbidity and mortality, hamper the administration of treatment, worsen the quality of life and increase the burden on the healthcare system. Therefore, their prompt identification is crucial. NICSO (Italian Network for Supportive Care in Cancer) conducted a nationwide randomized trial to evaluate the role of a planned, weekly phone-based nurse monitoring intervention to prevent and treat chemotherapy, targeted therapy- and immunotherapy-related toxicities. Here, we report the results from the chemotherapy arm. MethodsThis was a nationwide, randomized, open-label trial conducted among 29 Italian centers (NCT04726020) involving adult patients with breast, colon, or lung cancer and a life expectancy >= 6 months receiving adjuvant chemotherapy. Patients received either a weekly nurse monitoring phone call and an educational leaflet reporting practical advice about prevention and treatment of toxicities (experimental group) or the educational leaflet only (control group). ResultsThe addition of a nurse monitoring intervention may help reduce time spent with severe toxicities (grade >= 3), particularly those less frequently reported in clinical practice, such as fatigue. When considering grade 1-2 AEs, times with mild/moderate diarrhea, mucositis, fatigue and pain were shorter in the experimental arm. Time spent without AEs was significantly longer in the experimental arms for all the toxicities. The requirement for special medical attention was comparable between groups. ConclusionThis study suggests the need for implementing a better system of toxicity assessment and management for patients treated with adjuvant chemotherapy to promote effective preventive and/or therapeutic intervention against these events

Standardized postnatal management of infants with congenital diaphragmatic hernia in Europe: The CDH EURO Consortium Consensus - 2015 Update

In 2010, the congenital diaphragmatic hernia (CDH) EURO Consortium published a standardized neonatal treatment protocol. Five years later, the number of participating centers has been raised from 13 to 22. In this article the relevant literature is updated, and consensus has been reached between the members of the CDH EURO Consortium. Key updated recommendations are: (1) planned delivery after a gestational age of 39 weeks in a high-volume tertiary center; (2) neuromuscular blocking agents to be avoided during initial treatment in the delivery room; (3) adapt treatment to reach a preductal saturation of between 80 and 95% and postductal saturation >70%; (4) target PaCO2 to be between 50 and 70 mm Hg; (5) conventional mechanical ventilation to be the optimal initial ventilation strategy, and (6) intravenous sildenafil to be considered in CDH patients with severe pulmonary hypertension. This article represents the current opinion of all consortium members in Europe for the optimal neonatal treatment of CDH

Neonato con tumore miofibroblastico infiammatorio associato a trombocitopenia

Neonato di sesso maschile, nato a termine da parto eutocico. Gravidanza insorta da ICSI omologa, normodecorsa. IgG materne per CMV positive, IgM negative. Sierologia materna per toxoplasma, treponema, HIV e HCV, HBsAg, tamponi vagino-rettali negativi. Apgar 9-10, riscontro di tumefazione ovalare dell’avambraccio sinistro, dura, disomogenea, calda, con cute sovrastante integra. Contemporaneo riscontro di piastrinopenia (PLT 9000). PCR per CMV, EBV, ADV su sangue, indici infiammatori ed emocoltura negativi. Principali anticorpi anti-piastrine assenti. Eco-encefalo, eco-addome e radiografia del torace nella norma. Un’ecodoppler della tumefazione evidenziava una formazione espansiva di 35x21x25 mm, con margini lineari, ecostruttura disomogenea e accentuati segnali vascolari, in sede sovrafasciale. Una RM confermava un quadro suggestivo per anomalia vascolare. Veniva formulata l’ipotesi che si trattasse di emangioendotelioma kaposiforme e si attribuiva la trombocitopenia ad una verosimile sindrome di Kasabach-Merritt. Dopo l’asportazione della lesione all’analisi istologica veniva posta diagnosi di tumore miofibroblastico infiammatorio infantile. Normalmente la sindrome di Kasabach-Merritt si associa all’emangioendotelioma kaposiforme, mentre il tumore miofibroblastico infiammatorio si presenta spesso associato a trombocitosi, veniva quindi meno l’ipotesi diagnostica posta per l’eziologia della piastrinopenia. Per il persistere della piastrinopenia si approfondiva con: antigeni/anticorpi HIV, sottopopolazioni linfocitarie ed immunità umorale, dosaggio di LDH, creatinina, tutti risultati nella norma. L’aspirato midollare metteva in evidenza midollo a cellularità discreta, non elementi indifferenziati, rari megacariociti, numerosi aggregati piastrinici (recente terapia trasfusionale con concentrati piastrinici), esami genetici in corso. All’esame istologico della biopsia midollare si riscontrava midollo emopoietico con normale rappresentazione delle popolazioni cellulari. PCR per CMV, EBV, Parvovirus B19 e HHV6 su midollo osseo negative. All’immunofenotipo su aspirato midollare non rilevate popolazioni anomale. Venivano quindi escluse altre cause più rare di piastrinopenia quali la trombocitopenia amegacariocitica congenita (TAMC). Considerata l’origine periferica, venivano somministrate immunoglobuline endovena per due giorni consecutivi, con risoluzione della piastrinopenia. Discussione: Nel nostro caso i principali anticorpi antipiastrine risultavano assenti e si era ipotizzato che la piastrinopenia fosse dovuta alla sindrome di Kasabach-Merritt. La diagnosi istologica della lesione è risultata però essere di tumore miofibroblastico infiammatorio, normalmente non associato a trombocitopenia; quest’ultima tra l’altro persisteva nonostante l’escissione della lesione. Esami di secondo livello hanno permesso di identificare la condizione come periferica. Nonostante l’assenza dei principali anticorpi antipiastrine, si è deciso di somministrare immunoglobuline. Tale strategia ha portato alla immediata e persistente risalita dei valori delle piastrine, confermando quindi la diagnosi di trombocitopenia causata da anticorpi antipiastrine. Si ribadisce quindi la possibilità di interpretare la piastrinopenia come alloimmune anche se gli autoanticorpi principali dovessero risultare negativi. Nei laboratori generalmente vengono valutati i principali e non tutti i possibili anticorpi antipiastrine, tale esame rappresenta quindi un primo screening e per quanto la sua normalità ci possa far protendere verso altre diagnosi non dovrebbe far escludere a priori dalle possibili diagnosi differenziali la trombocitopenia causata da anticorpi contro le piastrine. Nel nostro specifico caso vista l’età del paziente si trattava verosimilmente di una NATP (Neonatal Alloimmune Thrombocytopenic Purpura), considerando anche il fatto che l’anamnesi patologica materna negativa per trombocitopenia permetteva teoricamente di escludere una ITP (Idiopathic Thrombocytopenic Purpura) materna

Reference Intervals for Coagulation Parameters in Developmental Hemostasis from Infancy to Adolescence

Background: The objective of this study was to establish the age and sex-dependent reference intervals for coagulation assays evaluated in healthy children, ranging from 0 days to 16 years old. Methods: PT, aPTT, Fibrinogen (functional), Antithrombin activity, Protein C anticoagulant activity, Protein S free antigen, Thrombin time, D-Dimer, Von Willebrand Factor antigen, Lupus anticoagulant (screening), extrinsic and intrinsic pathway factors, and activated Protein C resistance were evaluated using STA-R Max2. Results: A total of 1280 subjects (671 males and 609 females) were divided into five groups, according to their age: 0–15 days (n = 280, 174 M and 106 F), 15–30 days (n = 208, 101 M and 107 F), 1–6 months (n = 369, 178 M and 191 F), 6–12 months (n = 214, 110 M and 104 F), and 1–16 years (n = 209, 108 M and 101 F). The 95% reference intervals and the 90% CI were established using the Harrell–Davis bootstrap method and the bootstrap percentile method, respectively. Conclusions: The present study supports the concept that adult and pediatric subjects should be evaluated using different reference intervals, at least for some coagulation tests, to avoid misdiagnosis, which can potentially lead to serious consequences for patients and their families, and ultimately the healthcare system

Neonatal acute liver failure due to enteroviruses: a 14 years single NICU experience.

BACKGROUND: Neonatal acute liver failure (ALF) is a severe condition with a mortality rate up to 70%. Human enterovirus (HEV) infections are associated with serious diseases in newborns, including myocarditis, meningoencephalitis and, more rarely, ALF with a fulminant course. METHODS: Cases of neonatal-onset ALF were identified using the institutional clinical database. The history and clinical data of infants with HEV infection were collected by medical record revision. Viral testing by nested real- time PCR (nRT-PCR) was performed by the Bambino Gesù Children's Hospital Clinical Laboratory and by National Institute of Public Health in Rome. RESULTS: Among ten infants referred to our Institution with neonatal-onset ALF in the 2004-2018 period, we identified five cases due to HEV. In three of these, the mother reported an episode of mild fever and diarrhea during the last trimester of gestation, suggesting fetal-maternal transmission. All were late preterm infants (32-36 weeks). Two infants died as a result of ALF; the other three survived with full normalization of liver function. In four, the causing agents were coxsackie B serotypes 3 (n = 1), 4 (n = 1) and 5 (n = 2), in the fifth case we identified echovirus serotype 11. CONCLUSIONS: Human enterovirus (HEV) are a rare but relevant cause of ALF in neonates. HEV testing should be systematically performed in cases of neonatal ALF for diagnostic and management purposes

Propofol and fentanyl sedation for laser treatment of retinopathy of prematurity to avoid intubation.

BACKGROUND: Despite the optimization of neonatal assistance, severe retinopathy of prematurity (ROP, stage III-IV) remains a common condition among preterm infants. Laser photocoagulation usually requires general anesthesia and intubation, but extubation can be difficult and these infants often affected by chronic lung disease. We retrospectively evaluated the clinical charts of 13 neonates that were sedated with propofol in association with fentanyl for the laser treatment of ROP. This protocol was introduced in our unit to avoid intubation and minimize side effects of anesthesia and ventilation. METHODS: Propofol 5% followed by a bolus of fentanyl was administered as sedation during laser therapy to 13 preterm infants, affected by ROP stage III-IV. Propofol was initially infused as a slow bolus of 2-4 mg/kg and then continuously during the entire procedure, at 4 mg/kg/hour, increasing the dosage to 6 mg/kg/hour if sedation was not achieved. A laryngeal mask was placed and patients were ventilated with a flow-inflating resuscitation bag. RESULTS: Thirteen neonates were treated allowing to perform surgery without intubation. Only 4/13 (30.8%) of infants required minimal respiratory support during and/or after surgery. Heart rate after the intervention was higher than that at the beginning while remaining in the range of normal values. Blood pressures before, during and after surgery were similar. No episodes of bradycardia nor hypotension were recorded. Laser treatment was always successful. CONCLUSION: The good level of anesthesia and analgesia achieved sustains the efficacy of sedation with propofol during laser photocoagulation to avoid intubation and mechanical ventilation during and after the procedure

Conceptual design of a biped-wheeled wearable machine for ALS patients

In the presented work, the authors report the design of a biped-wheeled wearable machine adapted to meet the specifc needs of amyotrophic lateral sclerosis (ALS) patients