Evaluation of the impact of continuous Kangaroo Mother Care (KMC) initiated immediately after birth compared to KMC initiated after stabilization in newborns with birth weight 1.0 to < 1.8 kg on neurodevelopmental outcomes: Protocol for a follow-up study.

BACKGROUND: Preterm birth or low birth weight is the single largest cause of death in newborns, however this mortality can be reduced through newborn care interventions, including Kangaroo Mother Care (KMC). Previously, a multi-country randomized controlled trial, coordinated by the World Health Organization (WHO), reported a significant survival advantage with initiation of continuous KMC immediately after birth compared with initiation of continuous KMC a few days after birth when the baby is considered clinically stable. Whether the survival advantage would lead to higher rates of neurodevelopmental morbidities, or the immediate KMC will also have a beneficial effect on cognitive development also, has not been investigated. We therefore propose to test the hypothesis that low-birth-weight infants exposed to immediate KMC will have lower rates of neurodevelopmental impairment in comparison to traditional KMC-treated infants, by prospectively following up infants already enrolled in the immediate KMC trial for the first 2 years of life, and assessing their growth and neurodevelopment. METHODS: This prospective cohort study will enroll surviving neonates from the main WHO immediate KMC trial. The main trial as well as this follow-up study are being conducted in five low- and middle-income countries in South Asia and sub-Saharan Africa. The estimated sample size for comparison of the risk of neurodevelopmental impairment is a total of 2200 children. The primary outcome will include rates of cerebral palsy, hearing impairment, vision impairment, mental and motor development, and epilepsy and will be assessed by the age of 3 years. The analysis will be by intention to treat. DISCUSSION: Immediate KMC can potentially reduce low-birth-weight-associated complications such as respiratory disease, hypothermia, hypoglycemia, and infection that can result in impaired neurocognitive development. Neuroprotection may also be mediated by improved physiological stabilization that may lead to better maturation of neural pathways, reduced risk of hypoxia, positive parental impact, improved sleep cycles, and improved stress responses. The present study will help in evaluating the overall impact of KMC by investigating the long-term effect on neurodevelopmental impairment in the survivors. TRIAL REGISTRATION: Clinical Trials Registry-India CTRI/2019/11/021899. Registered on 06 November 2019. Trials registration of parent trial: ACTRN12618001880235; Clinical Trials Registry-India: CTRI/2018/08/015369.

Changes in the provision of undergraduate ENT clinical placements across the UK in response to the coronavirus disease 2019 pandemic.

OBJECTIVE: This study aimed to report the changes made to ENT placements across the UK in response to the pandemic and their impact on student experience. METHODS: A questionnaire eliciting how ENT placements were provided before and after coronavirus disease 2019 was disseminated amongst Student and Foundation Doctors in Otolaryngology representatives. RESULTS: Thirty-eight respondents from 27 medical schools across the UK completed the survey (response rate of 90 per cent). Twenty-nine of the 38 respondents (76 per cent) reported a change in ENT placements in response to the pandemic. Six of the 38 students (16 per cent) remained satisfied with their ENT placements, as compared to 12 students prior to the pandemic (32 per cent). CONCLUSION: There is considerable variability in how medical schools responded to the pandemic. Most medical schools placed students into smaller groups, with less direct contact in the hospital. These changes resulted in lower student satisfaction. The increased emphasis on e-learning underscores the need for high quality e-learning materials to promote learning throughout the pandemic and in the future.

The provision of undergraduate clinical placements in ENT during the coronavirus disease 2019 pandemic - exploring patient perspectives on a variety of approaches.

BACKGROUND: The coronavirus disease 2019 pandemic has greatly disrupted routine ENT services. Subsequently, universities have chosen to either augment or suspend clinical placements. OBJECTIVE: This study aimed to elicit patients' perspectives toward various approaches to clinical placements in ENT during the coronavirus disease 2019 pandemic. METHODS: Cross-sectional questionnaires were given to patients attending the ENT department for routine out-patient care. Responses were measured using a five-point Likert scale. Seventy-nine patients completed the survey. RESULTS: Ninety-five per cent of respondents felt the coronavirus disease 2019 pandemic had not reduced their comfort in interacting with medical students. Most participants reported being comfortable with students participating directly or remotely in their care, and with students having access to their anonymised data. Twenty-five per cent of participants stated that they are uncomfortable with consultations being recorded and shared for medical education purposes. CONCLUSION: A number of approaches to clinical placements remain acceptable to patients. Educational leads should continue to offer placements in ENT that can incorporate direct or remote observation of consultations.

Effect of surgery, delivery device and head position on sinus irrigant penetration in a cadaver model.

OBJECTIVE: The extent of surgery, the type of device used and head position may influence nasal irrigation. The aim of this study was to determine the effectiveness of topical irrigant delivery to the paranasal sinuses according to these factors. METHOD: Four cadaveric heads underwent four stepwise endoscopic dissections. Irrigations were evaluated after every stage using different delivery devices (squeeze-bottle, gravity-dependent device and syringe) in two head positions (nose-to-sink and vertex down). Irrigant penetration into each sinus was estimated using a four-point scale. RESULTS: A significant positive effect of surgery was demonstrated for each sinus as well as for the delivery device. High-volume irrigant devices are more effective, and the head position plays a significant role in irrigant distribution to the frontal sinus. CONCLUSION: This study further confirms the efficacy of high-volume irrigant devices. A vertex down position during the irrigation could improve delivery to the frontal sinus, and the widening of the ostia increases irrigant access to the sinuses.

Impact of Time on Thrombolysis in Cerebral Infarction Score Results.

PURPOSE: Extended thrombolysis in cerebral infarction (eTICI) score results of 2b or higher are known to be predictors for favorable outcome after acute stroke. Additionally, time is a major factor influencing outcome after ischemic stroke. Until today only little is known about the impact of time on angiographic results regarding the outcome after mechanical thrombectomy; however, this impact might be of interest if an initially unfavorable angiographic result has to be improved. METHODS: Retrospective study of 164 patients with large vessel occlusion of the anterior circulation treated by mechanical thrombectomy. Multiple logistic regression analysis of relevant periprocedural and procedural times in respect to the probability of achieving functional independence at 90 days in respect to different eTICI results was performed to build a time and TICI score-dependent model for outcome prediction in which the influence of time was assumed to be steady among the TICI grades. RESULTS: The probability of achieving a favorable outcome is significantly different between eTICI2b-50, 67, TICI2c and TICI3 results (p < 0.001). The odds for achieving a favorable outcome decrease over time and differ for each TICI category and time point. The individual odds for each patient, time point and TICI grade can be calculated based on this model. CONCLUSION: The impact of periprocedural and procedural times and eTICI reperfusion results adds a new dimension to the decision-making process in patients with primary unfavorable angiographic results.

Double-blind, randomised controlled trial on the efficacy of saline nasal irrigation with sodium hyaluronate after endoscopic sinus surgery.

OBJECTIVE: There is a growing interest in sodium hyaluronate for the clinical management of patients who undergo functional endoscopic sinus surgery for chronic rhinosinusitis, because of the mucosal regenerative properties of this macromolecule. However, its role in post-operative care is still debated. This study aimed to evaluate the effect of sodium hyaluronate administered via nasal irrigation with saline, in the post-operative period, after functional endoscopic sinus surgery. METHODS: A multicentric, prospective, randomised, double-blind, parallel group study was conducted on 56 consecutive patients who underwent functional endoscopic sinus surgery for chronic rhinosinusitis without polyps. Group 1 received the standard therapy of normal saline; group 2 received saline plus sodium hyaluronate. RESULTS: Both objective and subjective measurements, in terms of endoscopic appearance and patient-reported satisfaction, were significantly better in group 2 compared to group 1. CONCLUSION: Sodium hyaluronate may be a useful adjunct to nasal saline irrigation in the early post-operative period following functional endoscopic sinus surgery.

Horizontal lateral lamella as a risk factor for iatrogenic cerebrospinal fluid leak. Clinical retrospective evaluation of 24 cases.

BACKGROUND: Several authors highlighted the limitations of the Keros classification system in predicting intracranial entry risk. Recently, our group proposed a new classification system based on the angle formed between the lateral lamella of the cribriform plate (LLCP) and the continuation of an horizontal plane passing through the cribriform plate (Gera classification). The aim of this study was to analyze whether the risk of iatrogenic cerebrospinal fluid leak (CSF-L) was better predicted by Keros or Gera classification. METHODOLOGY: The pre-operative CT scans of 24 patients (CSF-L group) who suffered from iatrogenic CSF-L during endoscopic sinus surgery (ESS) were compared to those obtained from a group of 100 patients who underwent uneventful ESS (control group). The skull base measurements as well as the distribution of Keros and Gera classes in the 2 groups were analyzed. RESULTS: No difference in the distribution of Keros classes or in the depth of the cribriform plate between CSF-L and control group were demonstrated. On the contrary, significant differences in the distribution of Gera classes and in the degree of the angle formed by the LLCP and the continuation of the horizontal plane passing through the cribriform plate were found. In particular, according to Gera classification system, 19 out of 24 patients in the CSF-L group were considered at risk for iatrogenic CSF-L. CONCLUSIONS: Gera classification system might be more sensitive to anatomical variations associated with CSF-L than the Keros one, further suggesting the application of the former during the preoperative CT scan evaluation.

Lateral lamella of the cribriform plate, a keystone landmark: proposal for a novel classification system.

BACKGROUND: The aim of this study is to propose a classification of the angle formed by the lateral lamella of the cribriform plate (LLCP) and the horizontal plane passing through the cribriform plate. In particular, the angle was classified into class I (over 80 degrees), class II (45 to 80 degrees, and class III (under 45 degrees) METHODOLOGY: A total of 190 computed tomography scans were retrospectively reviewed in order to obtain four sets of measurements. 1) depth of the cribriform, 2) angle, 3) length of the LLCP, 4) width of the fovea ethmoidalis. The relationship among these measurements were analyzed. RESULTS: The angle was significantly correlated with the depth of the cribriform and the length of the fovea, while it was negatively correlated with the length of the LLCP. Significant negative correlation was also found between the length of the LLCP and the width of the fovea. CONCLUSIONS: This angle classification is based on the theoretical risk of iatrogenic injuries, but it could be helpful also in clinical practice by providing indirect information on the thickness of the anterior skull base. As the angle decreases, in fact, the portion of the anterior skull base composed by the LLCP, increases.

Cross-cultural adaptation and validation of the SNOT-22 into Italian.

The aim of this study is to evaluate the reliability and validity of the Italian SNOT-22 (I-SNOT-22). The study consisted of five phases: item generation, reliability analysis, normative data generation, validity analysis and responsiveness analysis. The item generation phase followed the five-step, cross-cultural, adaptation process of translation and back-translation. A group of 222 patients with chronic rhinosinusitis (CRS) were enrolled for the internal consistency analysis. Sixty patients completed the I-SNOT-22 twice, 2 weeks apart, for test-retest reliability analysis. A group of 119 asymptomatic subjects completed the I-SNOT-22 for normative data generation. I-SNOT-22 scores obtained by CRS patients and asymptomatic subjects were compared for validity analysis. I-SNOT-22 scores were correlated with Lund-Mackay and visual analogue scale (VAS) scores in 50 CRS patients for criterion validity analysis. Finally, I-SNOT-22 scores obtained in a group of 59 CRS patients before and after surgical treatment for CRS were compared for responsiveness analysis. All the enrolled subjects managed to complete the I-SNOT-22 without needing any assistance. Internal consistency was satisfactory (α = 0.86). Test-retest reliability was also satisfactory (ICC = 0.85). A significant difference in the I-SNOT-22 scores between the CRS patients and the asymptomatic subjects was found (p < 0.008). Positive significant correlations were found between I-SNOT-22 and VAS scores, while no significant correlations were found between I-SNOT-22 scores and Lund-Mackay scores. I-SNOT-22 scores obtained in the pre-treatment condition were significantly higher than those obtained after surgery. I-SNOT-22 is reliable, valid, responsive to changes in QOL, and recommended for clinical practice and outcome research.

Sinonasal inverted papilloma: 84 patients treated by endoscopy and proposal for a new classification.

AIM: To suggest a new classification system for sinonasal papilloma based on a critical analysis of surgical indications and results obtained. METHODS: We analysed surgical data from 84 cases of sinonasal papilloma treated endoscopically. RESULTS: In 58 males and 26 females, between 25 and 85 years, the ethmoid sinus (63 cases), the maxillary sinus (43), and the nasal fossa (22) were mostly involved. No case of endocranial extension or carcinoma was reported. Complications were reported in 15.4% of patients, as well as 5 recurrences (5.9%). Median follow up was 39,5 months. To categorise the tumour for the most appropriate surgical treatment, we propose a classification based on 6 main categories that depend on the location, origin and extension of the tumour. CONCLUSION: The classification that we propose presents advantages for prognosis and surgical indication in comparison with other classifications.

Nondisclosure of human immunodeficiency virus and hepatitis C virus coinfection in a patient with hemophilia: medical and ethical considerations.

This article discusses a medical and ethical dilemma: whether to disclose a positive HIV (human immunodeficiency virus)/HCV (hepatitis C virus) coinfection to an adolescent boy without symptoms with hemophilia despite the objections of his parents. An actual case history is presented and the dilemma faced by the medical team is discussed. Numerous family conferences, all excluding the patient, held during the last 5 years discussed the medical team's obligation for full disclosure, the emerging autonomy of the patient, and the potential for medical disaster (e.g., HIV transmission) if full disclosure were not permitted. Despite this, the family did not agree to allow disclosure. The patient and parents assured us of his sexual inactivity. Legal opinion was sought from the university counsel. The dilemmas are multiple. Is there a convincing argument to insist on disclosure of these facts to this patient, particularly when there is ambiguity regarding the appropriateness of HIV and HCV treatment? Does the ethical argument that he is at potential risk for transmitting HIV/HCV outweigh the rights of the family? What are the rights of the rest of the family? What are the rights of the minor? Is it our ethical responsibility to disclose a probably fatal diagnosis?

Successful treatment of high titer inhibitors in mild hemophilia A with avoidance of factor VIII and immunosuppressive therapy.

We describe two patients with mild hemophilia A (MHA) who developed high titer inhibitor (HTI) following intensive recombinant factor VIII (rFVIII) concentrate replacement for surgery and trauma. Intranasal desmopressin was instituted shortly following immunosuppressive therapy (IST) and activated prothrombin complex concentrate (APCC) in one case, and following APCC alone in the second case. Avoidance of factor VIII (FVIII) coupled with intranasal desmopressin prophylaxis three times a week resulted in undetectable inhibitor levels. Both patients have had no further bleeding episodes and have been maintained on desmopressin prophylaxis prior to activity for the past 2 to 3 years. Recombinant factor VIIa (rFVIIa) was used successfully prior to a second surgery in one patient without complication.

[Paranasal sinus mycoses]. / Le micosi rinosinusali.

In recent years there has been a marked increase in mycosis infections of the paranasal sinuses, attributed both to an increase in the survival of subjects at risk and improved diagnostic techniques (endoscopy, CT, MR) able to identify cases which had previously gone unrecognized and treated as aspecific chronic sinusitis. The present study involves 45 cases (4.3%) out of a total of 1050 patients who had undergone endoscopic surgery for sinusopathy between April 1994 and December 1998. Following the Katzenstein classification, the cases were broken down into non-invasive chronic mycoses or fungus ball (34 cases), allergic mycoses (7), chronic indolent invasive mycoses (3) and fulminating invasive mycosis (1 case). The mycetes most often involved was Aspergillus Fumigatus (76.9%). The recurrent symptom was facial algia, followed by nasal obstruction. Paranasal sinuses endoscopy did not modify the specific picture. CT presented such indicative signs as focal areas with non-homogeneous intensity, images of metal-like foreign bodies and endosinus calcifications in 84.4% of the cases. MR--performed in only 6 cases--always presented T2 images showing the typical signal void area corresponding to pathological lesions. All patients underwent endoscopic surgery of the paranasal sinus. The effectiveness of this treatment differed according to the clinical form. In the fungus balls surgery always resolved the pathology without requiring subsequent pharmacological treatment. In allergic mycosis, surgery improved the symptom of nasal respiratory obstruction but local drug treatment was required. With the aid of drug treatment, surgery resolved chronic indolent invasive mycoses and prevented the endocranial progression of complications. In the cases of fulminating invasive mycosis, timely surgery prevented the onset of endocranial complications and made it possible to perform antimycotic polychemotherapy to control the disease. This experience shows how important a protocol involving several different tests is in diagnosing the many clinical forms of paranasal sinus mycoses and distinguishing them from sinusopathies. Endoscopic surgery is indicated for all forms of paranasal sinus mycoses although the realistic objectives differ according to type.

Venous thromboembolism.

Incidence of venous thromboembolism (VTE) in children is rapidly rising. Frequent use of central venous lines (CVLs) in children with a variety of disease processes has contributed to increased incidence of VTE. In addition, increased detection of VTE has been possible due to the availability of sensitive imaging studies such as Color Duplex/Doppler ultrasound, lineogram and venogram. Heightened awareness of congenital prethrombotic disorders may help identify children at higher risk of thrombosis. Anticoagulation with heparin, low molecular weight heparin (LMWH) and oral anticoagulant such as warfarin are used for the treatment of VTE. Thrombolytic therapy may be indicated in some cases. Clinical presentation, management and pathogenesis including role of congenital prethrombotic disorders in pediatric VTE are discussed.

Pediatric transfusion therapy: practical considerations.

Over the past decade, safety of blood has increased tremendously because of better donor screening as well as testing of the units for transmissible diseases. Component therapy has allowed more effective and economic use of blood. Whole blood is rarely used; instead, packed red cells, platelets, and fresh frozen plasma (FFP) are the most common components used. These products are further refined using irradiation and microaggregate filters and in the case of FFP, viral inactivation. Irradiation prevents transfusion-associated graft versus host disease, whereas microaggregate filters remove leukocytes, decreasing the rates of alloimmunization, febrile nonhemolytic (FNH) reactions, and cytomegalovirus (CMV) transmission. Autologous donation in older children probably provides the safest blood as far as transmissible diseases are concerned. More families request a directed donation and solicit physician help in deciding as well as making arrangements for autologous and/or directed donations. Transfusions of blood and blood components in children are often challenging and require a knowledge of physiologic changes in hemoglobin and blood volumes during different ages. The unique needs of neonates, immunocompromised patients, and patients with congenital hemolytic anemia (sickle cell, thalassemia) mandate that the pediatrician have an appropriate knowledge of transfusion volumes and choice of blood product as well as indications for transfusion.

Physiological and biochemical characterization of intergeneric hybrids of thermotolerant and non-thermotolerant yeasts.

Kluyveromyces-like intergeneric hybrids of thermotolerant Kluyveromyces marxianus and non-thermotolerant Saccharomyces cerevisiae, produced in a previous study by protoplasmic fusion, have been characterized. On molasses, these strains produced ethanol in excess of 6% (v/v) both at 30 and 45 degrees C as against 3% and 4.2% (v/v) by the former parent at 30 and 45 degrees C, respectively. In hybrids, the increase in ethanol production appeared to be a sequel to increased activities of alcohol dehydrogenase and pyruvate kinase, derived probably from S. cerevisiae parent. Hybrid ADH-isozyme pattern on polyacrylamide gel corroborated the presence of S. cerevisiae ADH in the tested hybrids. Regression analyses indicated a positive correlation between ethanol production and ADH or PK or both (r approximately 0.76-0.84).

Penicillin-resistant Streptococcus mitis as a cause of septicemia with meningitis in febrile neutropenic children.

PURPOSE: The purpose of this report is to emphasize the importance of occurrence of Streptococcus mitis meningitis in febrile neutropenic children with hematopoietic malignancy. PATIENTS AND METHODS: Symptoms of meningitis and sepsis (fever, headache, changes in mental status) were seen in three patients who were severely neutropenic and undergoing cytotoxic chemotherapy for CNS relapse of their underlying malignancy (acute lymphoblastic leukemia (ALL), n = 2; Burkitt's lymphoma, n = 1). Chemotherapy had included cytosine arabinoside administered 7-14 days prior to presenting with sepsis and meningitis. All three patients had buccal mucositis or sinusitis. Blood cultures and CSF cultures showed S. mitis resistant to penicillin but sensitive to vancomycin. Vancomycin, at a dosage of 60 mg/kg/day to maximize CNS levels of antibiotic, was administered to all three children. RESULTS: Two of the patients recovered from S. mitis meningitis; recovery was associated with an improvement in their peripheral granulocyte counts. One patient, who remained neutropenic, died despite being treated with both intravenous and intraventricular vancomycin. CONCLUSION: Physicians caring for patients who are neutropenic and febrile need to be aware of the risk of meningitis occurring with S. mitis sepsis. Early treatment with high dosages of vancomycin (60 mg/kg/day) and an attempt to limit the duration of neutropenia are important factors in the outcome of such patients.