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Estudio primario

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A randomized trial of nebulized 3% hypertonic saline with salbutamol in the treatment of acute bronchiolitis in hospitalized infants.

Autores Flores P , Mendes AL , Neto AS
Revista Pediatric pulmonology
Año 2016
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Este artículo está incluido en 5 Revisiones sistemáticas Revisiones sistemáticas (5 referencias)

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OBJECTIVE: Acute bronchiolitis is a common disorder of infants that often results in hospitalization. Apart from supportive care, no therapy has been shown to influence the course of the disease, except for a possible effect of nebulized hypertonic saline (HS). To determine whether this does have beneficial effects on length of stay in hospital or on severity scores, we undertook a double-blind, randomized, controlled trial in a pediatric department of a Portuguese hospital. METHODS: Previously healthy infants, younger than 12 months, hospitalized with mild-to-moderate acute viral bronchiolitis were randomized to receive either nebulized 3% (hypertonic, HS) or 0.9% (normal, NS) saline during their entire hospital stay. Primary endpoints were: length of hospital stay and severity scores on each day of hospitalization. Need for supplemental oxygen, further add-on medications and adverse effects were also analyzed. RESULTS: Sixty-eight patients completed the study (HS: 33; NS: 35). The median length of hospital stay did not differ between groups: HS: 5.6 ± 2.3 days; NS: 5.4 ± 2.1 days (P = 0.747). We found no difference between groups in severity scores from day 1 to day 4. There were no differences in need for supplemental oxygen or add-on medications. Patients in HS group had significantly more cough (46% vs. 20%, P = 0.025) and rhinorrhoe (58% vs. 31%, P = 0.30). CONCLUSION: This study does not support the use of nebulized HS over NS in therapy of hospitalized children with mild-to-moderate acute viral bronchiolitis.

Estudio primario

No clasificado

Therapeutic effects of Ventolin versus hypertonic saline 3% for acute bronchiolitis in children.

Revista Medical journal of the Islamic Republic of Iran
Año 2015
Enlaces Pubmed PubMed Central

Este artículo está incluido en 2 Revisiones sistemáticas Revisiones sistemáticas (2 referencias)

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BACKGROUND: Complications of Ventolin as the most common drug used for bronchiolitis are widely known. The present study was conducted to determine the efficacy of hypertonic saline 3%, compared with Ventolin, for treatment of acute bronchiolitis in children. METHODS: This double-blinded clinical trial study was conducted in Hajar Hospital, Shahrekord, Iran, from 2011 to 2012. A total of 70 patients under the age of two years with bronchiolitis were divided into two groups of 35 each. Ventolin nebulizer and hypertonic saline 3% nebulizer three times per day were administered in the first (Ventolin) and second (Hypersaline) group, respectively. The length of recovery was compared between the two groups. The data were analyzed by SPSS software (version 22) using chi-square, t-test, paired t-test, and Mann-Whitney. RESULTS: The mean±SD length of recovery was 4.14±0.9 and 3.06±0.6 in the Ventolin and hypersaline groups, respectively. The mean duration of recovery was significantly lower in the hypersaline group (p<0.001). CONCLUSION: Hypertonic saline 3% nebulizer has more pleasant therapeutic effects on acute bronchiolitis than Ventolin. Therefore, use of hypertonic saline 3% nebulizer is recommended for the treatment of acute bronchiolitis in children under two years old.

Estudio primario

No clasificado

Nebulised hypertonic saline (3%) among children with mild to moderately severe bronchiolitis--a double blind randomized controlled trial.

Revista BMC pediatrics
Año 2015
Enlaces Pubmed DOI PubMed Central

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BACKGROUND: To Assess the efficacy of nebulised hypertonic saline (HS) (3%) among children with mild to moderately severe bronchiolitis. METHODS: Infants aged 6 weeks to 24 months, with a first episode of wheezing and Clinical Severity scores (Arch Dis Child 67:289-93, 1992) between 1 and 8, were enrolled over 4 months duration. Those with severe disease, co-morbidities, prior wheezing, recent bronchodilator and steroid use were excluded. Patients were randomized in a double-blind fashion, to receive two doses of nebulized 3% HS (Group 1) or 0.9% normal saline (Group 2) with 1.5 mg of L-Epineprine, delivered 30 min apart. Parents were contacted at 24 h and 7 days. The principal outcome measure was the mean change in clinical severity score at the end of 2 h of observation. RESULTS: A total of 100 infants (mean age 9.6 months, range 2-23 months; 61 % males) were enrolled. Patients in both groups had mild to moderately severe disease at presentation. On an intention-to-treat basis, the infants in the HS group had a significant reduction (3.57 ± 1.41) in the mean clinical severity score compared to those in the NS group (2.26 ± 1.15); [p < 0.001; CI: 0.78-1.82]. More children in the HS group (n = 35/50; 70.0%) were eligible for ER/OPD discharge at the end of 2 h than those in the NS group (n = 15/50; 30%; p < 0.001), and less likely to need a hospital re-visit (n = 5/50; 10.0%) in the next 24 h as compared to the NS group (n = 15/50, 30.0%; p < 0.001). The treatment was well tolerated, with no adverse effects. CONCLUSIONS: Nebulized 3% HS is effective, safe and superior to normal saline for outpatient management of infants with mild to moderately severe viral bronchiolitis in improving Clinical Severity Scores, facilitating early Out-Patient Department discharge and preventing hospital re-visits and admissions in the 24 h of presentation. TRIAL REGISTRATION: Clinicaltrials.gov NCTID012766821. Registered on January 12, 2011.

Estudio primario

No clasificado

Effect of combined dexamethasone therapy with nebulized r-epinephrine or salbutamol in infants with bronchiolitis: A randomized, double-blind, controlled trial.

Revista Avicenna journal of medicine
Año 2014
Enlaces Pubmed DOI PubMed Central

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BACKGROUND: This study investigated the effect of combining oral dexamethasone with either nebulized racemic epinephrine or salbutamol compared to bronchodilators alone for the treatment of infants with bronchiolitis. MATERIALS AND METHODS: This was a double-blind, randomized controlled trial on infants (1 to 12 months) who were diagnosed in the emergency department with moderate-to-severe bronchiolitis. The primary outcome was the rate of hospital admission within 7 days of the first dose of treatment, and the secondary outcomes were changes in respiratory distress assessment instrument score, heart rate, respiratory rate, and oxygen saturation (O2 Sat) over a 4-hour observation period. Infants (n = 162) were randomly assigned to four groups: A (dexamethasone + racemic epinephrine) = 45, B (placebo and racemic epinephrine) =39, C (dexamethasone and salbutamol) = 40, or D (placebo and salbutamol) = 38. RESULTS: Patients who had received dexamethasone + epinephrine exhibited similar admission rates compared to placebo + epinephrine or salbutamol (P = 0.64). Similarly, no statistically significant difference was observed in the rate of hospitalization for patients who received dexamethasone + salbutamol compared to those who received placebo + epinephrine or salbutamol (P = 0.51). Clinical parameters were improved at the end of the 4-hour observation period for all treatment groups. Treatment with dexamethasone + epinephrine resulted in a statistically significant change in HR over time (P < 0.005) compared to the other groups. CONCLUSIONS: This study adds to a body of evidence suggesting that corticosteroids have no role in the management of bronchiolitis for young infants who are first time wheezers with no risk of atopy.

Estudio primario

No clasificado

Nebulized hypertonic saline for bronchiolitis in the emergency department: a randomized clinical trial.

Revista JAMA pediatrics
Año 2014
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Este artículo está incluido en 5 Revisiones sistemáticas Revisiones sistemáticas (5 referencias)

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IMPORTANCE: Acute bronchiolitis is the most frequent lower respiratory tract infection in infants, yet there are no effective therapies available. Current evidence is unclear about the role of hypertonic saline (HS) for the acute treatment of bronchiolitis. OBJECTIVE: To determine whether nebulized 3% HS compared with normal saline (NS) improves respiratory distress in infants with bronchiolitis not responding to standard treatments in the emergency department. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial with blinding of investigators, health care providers, and parents was conducted at a single urban pediatric ED. The participants included children aged 2 to less than 24 months with their first episode of bronchiolitis and a Respiratory Distress Assessment Instrument score of 4 to 15 after nasal suctioning and a trial of nebulized albuterol. INTERVENTIONS: Patients were randomized to receive either nebulized 3% HS (HS group) or NS (NS group). MAIN OUTCOMES AND MEASURES: The primary outcome was change in respiratory distress at 1 hour after the intervention, as measured by the Respiratory Assessment Change Score (a decrease indicates improvement). Secondary outcomes included vital signs, oxygen saturation, hospitalization, physician clinical impression, parental assessment, and adverse events. RESULTS: The 31 patients enrolled in each treatment arm had similar baseline demographic and clinical characteristics. At 1 hour after the intervention, the HS group demonstrated significantly less improvement in the median Respiratory Assessment Change Score compared with the NS group (HS, -1 [interquartile range, -5 to 1] vs. NS, -5 [interquartile range, -6 to -2]; P = .01). There were no significant differences in heart rate, oxygen saturation, hospitalization rate, or other outcomes. There were no adverse events. CONCLUSIONS AND RELEVANCE: Infants with bronchiolitis and persistent respiratory distress after standard treatment in the emergency department had less improvement after receiving 3% HS compared with those who received NS. Based on these results and the existing evidence, administration of a single dose of 3% HS does not appear to be indicated to treat bronchiolitis in the acute care setting. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01247064.

Estudio primario

No clasificado

A comparative study on use of 3% saline versus 0.9% saline nebulization in children with bronchiolitis.

Autores Ojha AR , Mathema S , Sah S , Aryal UR
Revista Journal of Nepal Health Research Council
Año 2014
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Este artículo está incluido en 8 Revisiones sistemáticas Revisiones sistemáticas (8 referencias)

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BACKGROUND: Bronchiolitis is a common clinical problem in children below 2 years presenting with respiratory symptoms. As there is necrosis and sloughing of epithelial cells, edema, increased secretion of mucus causing obstruction of large and small airways we aim to see the clinical profile and the effect of use of hypertonic (3%) saline nebulization in these children. METHODS: A double blind randomized controlled trial was conducted at department of Pediatrics, in a hospital from July 2012 to August 2013. The computer generated random number was used to select the case and control group. All eligible patients were randomly assigned to one of two groups: receiving inhalation of 4 ml normal (0.9%) saline or hypertonic (3%) saline. Treating physicians, researchers and nurses were all blinded of the solution. Both saline were kept in two identical containers and labeled as solution A and solution B. Patients in each group will receive three treatments on each day of hospitalization and clinical score were obtained 30 minutes before each inhalation session. RESULTS: Bronchiolitis accounted 11.26% of total admissions. Their mean age (±SD) was 8.56 (±5.013) months with range from 45 days to 24 months. A total of 53 (74%) male were enrolled in the study. Fifty-seven (79%) children were less than 12 months and 15 (21%) were 12 months - 24 months. The mean (±SD) for duration of hospital stay was 44.82 (±23.15) and 43.60 (±28.25) for 3% and 0.9% group respectively (p=0.86). Likewise, mean (SD) duration of oxygen supplementation was 32.50 (±20.44) and 34.50 (±26.03) for 3% and 0.9% group respectively (p=0.85). Moreover, time required for normalization of clinical score was 36.79 (±19.53) and 38.34 (±26.67) for 3% and 0.9% group respectively (p=0.80). CONCLUSIONS: There is no advantage of hypertonic saline over normal saline nebulization in the management bronchiolitis.

Estudio primario

No clasificado

Nebulized hypertonic saline for bronchiolitis: a randomized clinical trial.

Revista JAMA pediatrics
Año 2014
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Este artículo está incluido en 7 Revisiones sistemáticas Revisiones sistemáticas (7 referencias)

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IMPORTANCE: Bronchiolitis is one of the most common and costly respiratory diseases in infants and young children. Previous studies have shown a potential benefit of nebulized hypertonic saline; however, its effect in the emergency department (ED) setting is unclear. OBJECTIVE: To compare the effect of nebulized 3% hypertonic saline vs 0.9% normal saline on admission rate and length of stay in infants with bronchiolitis. DESIGN, SETTING, AND PARTICIPANTS: We conducted a double-blind, randomized clinical trial during 3 consecutive bronchiolitis seasons from March 1, 2008, through April 30, 2011. We recruited a convenience sample of patients younger than 24 months with a primary diagnosis of viral bronchiolitis presenting to the ED of 2 urban free-standing tertiary children's hospitals. We excluded patients who were premature (gestational age, <34 weeks) or who had chronic pulmonary disease, immune deficiency, cardiac disease, or previous episodes of wheezing or inhaled bronchodilator use. Of eligible patients who were approached, 161 (26.6%) declined to participate. INTERVENTIONS: Patients received 4 mL of 3% sodium chloride (hypertonic saline [HS group]) or 0.9% sodium chloride (normal saline [NS group]) inhaled as many as 3 times in the ED. Those admitted received the assigned medication every 8 hours until discharge. All treatment solutions were premedicated with albuterol sulfate. MAIN OUTCOMES AND MEASURES: Hospital admission rate, length of stay for admitted patients, and Respiratory Distress Assessment Instrument score. RESULTS: A total of 197 patients were enrolled in the NS group and 211 in the HS group. Admission rate in the 3% HS group was 28.9% compared with 42.6% in the NS group (adjusted odds ratio from logistic regression, 0.49 [95% CI, 0.28-0.86]). Mean (SD) length of stay for hospitalized patients was 3.92 (5.24) days for the NS group and 3.16 (2.11) days for the HS group (P = .24). The Respiratory Distress Assessment Instrument score decreased after treatment in both groups; however, we found no significant difference between groups (P = .35). CONCLUSIONS AND RELEVANCE: Hypertonic saline given to children with bronchiolitis in the ED decreases hospital admissions. We can detect no significant difference in Respiratory Distress Assessment Instrument score or length of stay between the HS and NS groups. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00619918.

Estudio primario

No clasificado

7% Hypertonic saline in acute bronchiolitis: a randomized controlled trial.

Autores Jacobs JD , Foster M , Wan J , Pershad J
Revista Pediatrics
Año 2014
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Este artículo está incluido en 5 Revisiones sistemáticas Revisiones sistemáticas (5 referencias)

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BACKGROUND: Research suggests that hypertonic saline (HS) may improve mucous flow in infants with acute bronchiolitis. Data suggest a trend favoring reduced length of hospital stay and improved pulmonary scores with increasing concentration of nebulized solution to 3% and 5% saline as compared with 0.9% saline mixed with epinephrine. To our knowledge, 7% HS has not been previously investigated. METHODS: We conducted a prospective, double-blind, randomized controlled trial in 101 infants presenting with moderate to severe acute bronchiolitis. Subjects received either 7% saline or 0.9% saline, both with epinephrine. Our primary outcome was a change in bronchiolitis severity score (BSS), obtained before and after treatment, and at the time of disposition from the emergency department (ED). Secondary outcomes measured were hospitalization rate, proportion of admitted patients discharged at 23 hours, and ED and inpatient length of stay. RESULTS: At baseline, study groups were similar in demographic and clinical characteristics. The decrease in mean BSS was not statistically significant between groups (2.6 vs 2.4 for HS and control groups, respectively). The difference between the groups in proportion of admitted patients (42% in HS versus 49% in normal saline), ED or inpatient length of stay, and proportion of admitted patients discharged at 23 hours was not statistically significant. CONCLUSIONS: In moderate to severe acute bronchiolitis, inhalation of 7% HS with epinephrine does not appear to confer any clinically significant decrease in BSS when compared with 0.9% saline with epinephrine.

Estudio primario

No clasificado

Racemic adrenaline and inhalation strategies in acute bronchiolitis.

Revista The New England journal of medicine
Año 2013
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BACKGROUND: Acute bronchiolitis in infants frequently results in hospitalization, but there is no established consensus on inhalation therapy--either the type of medication or the frequency of administration--that may be of value. We aimed to assess the effectiveness of inhaled racemic adrenaline as compared with inhaled saline and the strategy for frequency of inhalation (on demand vs. fixed schedule) in infants hospitalized with acute bronchiolitis. METHODS: In this eight-center, randomized, double-blind trial with a 2-by-2 factorial design, we compared inhaled racemic adrenaline with inhaled saline and on-demand inhalation with fixed-schedule inhalation (up to every 2 hours) in infants (<12 months of age) with moderate-to-severe acute bronchiolitis. An overall clinical score of 4 or higher (on a scale of 0 to 10, with higher scores indicating more severe illness) was required for study inclusion. Any use of oxygen therapy, nasogastric-tube feeding, or ventilatory support was recorded. The primary outcome was the length of the hospital stay, with analyses conducted according to the intention-to-treat principle. RESULTS: The mean age of the 404 infants included in the study was 4.2 months, and 59.4% were boys. Length of stay, use of oxygen supplementation, nasogastric-tube feeding, ventilatory support, and relative improvement in the clinical score from baseline (preinhalation) were similar in the infants treated with inhaled racemic adrenaline and those treated with inhaled saline (P>0.1 for all comparisons). On-demand inhalation, as compared with fixed-schedule inhalation, was associated with a significantly shorter estimated mean length of stay--47.6 hours (95% confidence interval [CI], 30.6 to 64.6) versus 61.3 hours (95% CI, 45.4 to 77.2; P=0.01) - as well as less use of oxygen supplementation (in 38.3% of infants vs. 48.7%, P=0.04), less use of ventilatory support (in 4.0% vs. 10.8%, P=0.01), and fewer inhalation treatments (12.0 vs. 17.0, P<0.001). CONCLUSIONS: In the treatment of acute bronchiolitis in infants, inhaled racemic adrenaline is not more effective than inhaled saline. However, the strategy of inhalation on demand appears to be superior to that of inhalation on a fixed schedule. (Funded by Medicines for Children; ClinicalTrials.gov number, NCT00817466; EudraCT number, 2009-012667-34.).

Estudio primario

No clasificado

respuestas a respiración corriente albuterol y solución salina normal en lactantes con bronquiolitis viral

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Revista Pediatric Allergy, Immunology, and Pulmonology
Año 2012
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Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

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La Academia Americana de Pediatría recomienda el uso de un medio objetivo para evaluar la respuesta a un ensayo de la terapia con broncodilatadores en la bronquiolitis viral (VB), pero hay una subjetividad inherente con el uso de las evaluaciones clínicas. El objetivo de este estudio fue explorar la posibilidad de utilizar la pletismografía respiratoria inductiva (PIR) para servir como una medida objetiva de cambio en la función respiratoria en recién nacidos con VB recibir terapia de albuterol (ALB). Este fue un estudio doble ciego controlado con placebo, aleatorizado, en lactantes previamente sanos hospitalizados para VB. Los sujetos del estudio recibieron aleatoriamente ALB (0,1 mg / kg) o solución salina normal (NS) por nebulización. Se recogieron los datos RIP durante el sueño tranquilo determinada clínicamente antes y después del tratamiento. Se incluyó a un total de 20 sujetos de estudio; 10 recibieron ALB y 10 recibieron NS. La media de las medidas de respiración de marea no cambiaron significativamente en ninguno de los grupos después del tratamiento. Sin embargo, el ángulo de fase se redujo en> 40% del valor basal en 3 sujetos tratados con ALB (30%) y 4 NS (40%) - Los sujetos tratados. El uso de RIP, hemos observado mejoras en la función respiratoria en un subconjunto de recién nacidos tratados con ALB y con NS. Es posible que en sí NS tiene efectos beneficiosos. Nuestros resultados sugieren que RIP puede servir como una medida objetiva de la función respiratoria en los estudios de VB infantil.