816 resultados para PROSPECTIVE MULTICENTER


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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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Aim. To establish a protocol for the early introduction of inhaled nitric oxide (iNO) therapy in children with acute respiratory distress syndrome (ARDS) and to assess its acute and sustained effects on oxygenation and ventilator settings.Patients and Methods. Ten children with ARDS, aged 1 to 132 months (median, 11 months), with arterial saturation of oxygen <88% while receiving a fraction of inspired oxygen (FiO(2)) 0.6 and a positive end-expiratory pressure of greater than or equal to 10 cm H2O were included in the study. The acute response to iNO was assessed in a 4-hour dose-response test, and positive response was defined as an increase in the PaO2/FiO(2) ratio of 10 mmHg above baseline values. Conventional therapy was not changed during the test. In the following days, patients who had shown positive response continued to receive the lowest iNO dose. Hemodynamics, PaO2/FiO(2), oxygenation index, gas exchange, and methemoglobin levels were obtained when needed. Inhaled nitric oxide withdrawal followed predetermined rules.Results. At the end of the 4-hour test, all the children showed significant improvement in the PaO2/FiO(2) ratio (63.6%) and the oxygenation index (44.9%) compared with the baseline values. Prolonged treatment was associated with improvement in oxygenation, so that FiO(2) and peak inspiratory pressure could be quickly and significantly reduced., No toxicity from methemoglobin or nitrogen dioxide was observed.Conclusion. Administration of iNO to children is safe. iNO causes rapid and sustained improvement in oxygenation without adverse effects. Ventilator settings can safely be reduced during iNO treatment.

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Objectives: The aim of the study was to evaluate, over 24 months, the intake of dietary fiber (DF) and the bowel habit (BH) of constipated children advised a DF-rich diet containing wheat bran.Patients and Methods: BH and dietary data of 28 children with functional constipation defined by the Boston criteria were obtained at visit 1 (V1, n = 28) and at 4 follow-up visits (V2-V5, n = 80). At each visit the BH was rated BAD (worse/unaltered; improved but still complications) or RECOVERY (REC) (improved, no complications; asymptomatic), and a food intake questionnaire was applied. DF intake was calculated according to age (year)+5 to 10 g/day and bran intake according to international tables. Nonparametric statistics were used.Results: Median age (range) was 7.25 years (0.25-15.6 years); 21 children underwent bowel washout (most before V1/V2), and 14 had the last visit at V3/V4. DF intake, bran intake, and the BH rate significantly increased at V2 and remained higher than at V1 through V2 to V5. At V1, median DF intake was 29.9% below the minimum recommended and at the last visit 49.9% above it. Twenty-four children accepted bran at 60 visits, at which median bran intake was 20 g/day and median proportion of DF due to bran 26.9%. Children had significantly higher DF and higher bran intake at V2 to V5 at which they had REC than at those at which they presented BAD BH. DF intake > age+10 g/day was associated with bran acceptance and REC. At the last visit 21 children presented REC (75%); 20 of them were asymptomatic and 18 were off washout/laxatives.Conclusions: High DF and bran intake are feasible in constipated children and contribute to amelioration of constipation.

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Objective: To evaluate perinatal factors associated with early neonatal death in preterm infants with birth weights (BW) of 400-1,500 g.Methods: A multicenter prospective cohort study of all infants with BW of 400-1,500 g and 23-33 weeks of gestational age (GA), without malformations, who were born alive at eight public university tertiary hospitals in Brazil between June of 2004 and May of 2005. Infants who died within their first 6 days of life were compared with those who did not regarding maternal and neonatal characteristics and morbidity during the first 72 hours of life. Variables associated with the early deaths were identified by stepwise logistic regression.Results: A total of 579 live births met the inclusion criteria. Early deaths occurred in 92 (16%) cases, varying between centers from 5 to 31%, and these differences persisted after controlling for newborn illness severity and mortality risk score (SNAPPE-II). According to the multivariate analysis, the following factors were associated with early intrahospital neonatal deaths: gestational age of 23-27 weeks (odds ratio - OR = 5.0; 95%CI 2.7-9.4), absence of maternal hypertension (OR = 1.9; 95%CI 1.0-3.7), 5th minute Apgar 0-6 (OR = 2.8; 95%CI 1.4-5.4), presence of respiratory distress syndrome (OR = 3.1; 95%CI 1.4-6.6), and network center of birth.Conclusion: Important perinatal factors that are associated with early neonatal deaths in very low birth weight preterm infants can be modified by interventions such as improving fetal vitality at birth and reducing the incidence and severity of respiratory distress syndrome. The heterogeneity of early neonatal rates across the different centers studied indicates that best clinical practices should be identified and disseminated throughout the country.

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Objective. To describe the clinical and laboratory features of macrophage activation syndrome as a complication of juvenile systemic lupus erythematosus (SLE).Methods. Cases of juvenile SLE-associated macrophage activation syndrome were provided by investigators belonging to 3 pediatric rheumatology networks or were found in the literature. Patients who had evidence of macrophage hemophagocytosis on bone marrow aspiration were considered to have definite macrophage activation syndrome, and those who did not have such evidence were considered to have probable macrophage activation syndrome. Clinical and laboratory findings in patients with macrophage activation syndrome were contrasted with those of 2 control groups composed of patients with active juvenile SLE without macrophage activation syndrome. The ability of each feature to discriminate macrophage activation syndrome from active disease was evaluated by calculating sensitivity, specificity, and area under the receiver operating characteristic curve.Results. The study included 38 patients (20 with definite macrophage activation syndrome and 18 with probable macrophage activation syndrome). Patients with definite and probable macrophage activation syndrome were comparable with regard to all clinical and laboratory features of the syndrome, except for a greater frequency of lymphadenopathy, leukopenia, and thrombocytopenia in patients with definite macrophage activation syndrome. Overall, clinical features had better specificity than sensitivity, except for fever, which was highly sensitive but had low specificity. Among laboratory features, the best sensitivity and specificity was achieved using hyperferritinemia, followed by increased levels of lactate dehydrogenase, hypertriglyceridemia, and hypofibrinogenemia. Based on the results of statistical analysis, preliminary diagnostic guidelines for macrophage activation syndrome in juvenile SLE were developed.Conclusion. Our findings indicate that the occurrence of unexplained fever and cytopenia, when associated with hyperferritinemia, in a patient with juvenile SLE should raise the suspicion of macrophage activation syndrome. We propose preliminary guidelines for this syndrome in juvenile SLE to facilitate timely diagnosis and correct classification of patients.

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OBJECTIVE: This study aimed to compare the pelvic floor muscle strength of nulliparous and primiparous women.METHODS: A total of 100 women were prospectively distributed into two groups: Group 1 (G1) (n = 50) included healthy nulliparous women, and Group 2 (G2) (n = 50) included healthy primiparous women. Pelvic floor muscle strength was subjectively evaluated using transvaginal digital palpation. Pelvic floor muscle strength was objectively assessed using a portable perineometer. All of the parameters were evaluated simultaneously in G1 and were evaluated in G2 during the 20(th) and 36(th) weeks of pregnancy and 45 days after delivery.RESULTS: In G2, 14 women were excluded because they left the study before the follow-up evaluation. The median age was 23 years in G1 and 22 years in G2; there was no significant difference between the groups. The average body mass index was 21.7 kg/m(2) in G1 and 25.0 kg/m(2) in G2; there was a significant difference between the groups (p = 0.0004). In G2, transvaginal digital palpation evaluation showed significant impairments of pelvic floor muscle strength at the 36(th) week of pregnancy (p = 0.0006) and 45 days after vaginal delivery (p = 0.0001) compared to G1. Objective evaluations of pelvic floor muscle strength in G2 revealed a significant decrease 45 days after vaginal delivery compared to nulliparous patients.CONCLUSION: Pregnancy and vaginal delivery may cause weakness of the pelvic floor muscles.

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Vaginal weight cone (VWC) versus assisted pelvic floor muscle training (APFMT) in the treatment of urinary incontinence (UI) in women.One hundred three incontinent women were randomly distributed into two groups: group G1 (n = 51) treated with VWC and G2 (n = 52), APFMT. The following parameters were performed initially and after treatment: (1) clinical questionnaire, (2) visual analogue scale (VAS), (3) 60-min pad test, and (4) subjective and objective assessment of pelvic floor muscle (PFM).There was a significant decrease in nocturia and urine loss after treatment in both groups (p < 0.05). In VAS, there was a significant improvement of all parameters in both groups (p < 0.05). The pad test showed significant decrease in both groups (p < 0.05). There was a significant increase of PFM strength in both groups (p < 0.05).There was no difference between groups treated with VWC and APFMT.

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Purpose: Evaluate the impact autologous fascial sling (AFS) and tension-free vaginal tape (TVT) procedures on quality-of-life in incontinent women. Materials and Methods: Forty-one women were randomly distributed into two groups. Group G1 (n = 21), underwent AFS and group G2 (n = 20) TVT implant. The clinical follow up was performed at 1, 6, 12 and 36 months. Results: TVT operative time was significantly shorter than AFS. Cure rates were 71% at 1 month, 57% at 6 and 12 months in G1. In G2, cure rates were 75% at 1 month, 70% at 6 months and 65% at 12 months; there was no significant difference between groups. As regards the satisfaction rate, there was no statistical difference between groups. Analysis of quality of life at 36 months revealed that there was no significant difference between groups. Conclusion: Similar results between AFS and TVT, except for operative time were shorter in TVT.

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Background: This prospective and controlled histologic study evaluates the impact of smoking on bone-to-implant contact, the bone density in the threaded area, and the bone density outside the threaded area around microimplants with anodized surface retrieved from human jaws.Methods: A total of 24 subjects (mean age 51.32 +/- 7.5 years) were divided in two groups: smokers (n = 13 subjects) and non-smokers (n = 11 subjects). Each subject received one microimplant with oxidized surface during conventional mandible or maxilla implant surgery. After 8 weeks, the microimplants and the surrounding tissue were removed and prepared for histomorphometric analysis.Results: Three microimplants placed in smokers showed no osseointegration. The newly formed bone showed early stages of maturation, mainly in the non-smokers. Marginal bone loss, gap, and fibrous tissue were present around implants retrieved from smokers. Histometric evaluation indicated that the mean bone-to-implant contact ranged between 25.97% +/- 9.02% and 40.01% +/- 12.98% for smokers and non-smokers, respectively (P <0.001). Smokers presented 28.17% +/- 10.32% of bone density in the threaded area, whereas non-smokers showed 46.34% +/- 19.12%. The mean of bone density outside the threaded area ranged between 18.76% and 25.11% for smokers and non-smokers, respectively (P>0.05).Conclusion: The present data obtained in human subjects confirm that smoking has a detrimental effect on early bone tissue response around oxidized implant surfaces. J Periodontol 2010;81:575-583.

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Background. Predicting risk of posteruptive enamel breakdown (PEB) of molar-incisor hypomineralization (MIH) opacity is a difficult but important clinical task. Therefore, there is a need to evaluate these aspects through longitudinal studies.Objective. The aim of this longitudinal study was to analyse the relationship between colours of MIH opacity of children aged 6-12 (baseline) and other clinical and demographic variables involved in the increase in severity of MIH.Materials and methods. A blinded prospective 18-month follow-up was conducted with 147 individuals presenting mild MIH. Tooth-based incidence of increase in severity of MIH (PEB or atypical restorations) was used as dependent measurement. Enamel opacities were recorded according to colour shades of white, yellow and brown, allowing assessment of susceptibility to structural loss over time, according to colour of MIH opacity. Poisson regression models were used to adjust the results for demographic and clinical variables.Results. Brown and yellow MIH opacities were at higher risk for PEB and atypical restorations than those of white ones, even after adjustment for clinical and demographic variables.Conclusion. Teeth presenting mild MIH severity associated with yellow and brown enamel opacities were at high risk for increase in severity of MIH than lighter ones. This result could help clinicians determine a risk-based treatment for children with MIH.