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Effect of Nebulized Hypertonic Saline Treatment in Emergency Departments on the Hospitalization Rate for Acute Bronchiolitis: A Randomized Clinical Trial.

Revista JAMA pediatrics
Año 2017
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 5 Revisiones sistemáticas Revisiones sistemáticas (5 referencias)

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IMPORTANCE Acute bronchiolitis is the leading cause of hospitalization among infants. Previous studies, underpowered to examine hospital admission, have found a limited benefit of nebulized hypertonic saline (HS) treatment in the pediatric emergency department (ED). OBJECTIVE To examine whether HS nebulization treatment would decrease the hospital admission rate among infants with a first episode of acute bronchiolitis. DESIGN, SETTING, AND PARTICIPANTS The Efficacy of 3%Hypertonic Saline in Acute Viral Bronchiolitis (GUERANDE) study was a multicenter, double-blind randomized clinical trial on 2 parallel groups conducted during 2 bronchiolitis seasons (October through March) from October 15, 2012, through April 15, 2014, at 24 French pediatric EDs. Among the 2445 infants (6 weeks to 12 months of age) assessed for inclusion, 777 with a first episode of acute bronchiolitis with respiratory distress and no chronic medical condition were included. INTERVENTIONS Two 20-minute nebulization treatments of 4mL of HS, 3%, or 4 mL of normal saline (NS), 0.9%, given 20 minutes apart. MAIN OUTCOMES AND MEASURES Hospital admission rate in the 24 hours after enrollment. RESULTS Of the 777 infants included in the study (median age, 3 months; interquartile range, 2-5 months; 468 [60.2%] male), 385 (49.5%) were randomized to the HS group and 387 (49.8%) to the NS group (5 patients did not receive treatment). By 24 hours, 185 of 385 infants (48.1%) in the HS group were admitted compared with 202 of 387 infants (52.2%) in the NS group. The risk difference for hospitalizations was not significant according to the mixed-effects regression model (adjusted risk difference, -3.2%; 95%CI, -8.7%to 2.2%; P = .25). The mean (SD) Respiratory Distress Assessment Instrument score improvement was greater in the HS group (-3.1 [3.2]) than in the NS group (-2.4 [3.3]) (adjusted difference, -0.7; 95%CI, -1.2 to -0.2; P = .006) and similarly for the Respiratory Assessment Change Score. Mild adverse events, such as worsening of cough, occurred more frequently among children in the HS group (35 of 392 [8.9%]) than among those in the NS group (15 of 384 [3.9%]) (risk difference, 5.0%; 95%CI, 1.6%-8.4%; P = .005), with no serious adverse events. CONCLUSIONS AND RELEVANCE Nebulized HS treatment did not significantly reduce the rate of hospital admissions among infants with a first episode of acute moderate to severe bronchiolitis who were admitted to the pediatric ED relative to NS, but mild adverse events were more frequent in the HS group.

Estudio primario

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Effectiveness of 3% hypertonic saline nebulization in acute bronchiolitis among Indian children: A quasi-experimental study.

Revista Perspectives in clinical research
Año 2016
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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OBJECTIVE: To compare the effects of 3% hypertonic saline (HS) and 0.9% normal saline with nebulized 0.9% normal saline with salbutamol in patients of acute viral bronchiolitis. MATERIALS AND METHODS: Participants were divided into three groups, that is, 3% HS group, 0.9% normal saline group and 0.9% saline with salbutamol group. Four doses at interval of 6 h were given daily until discharge. Average CS score and length of hospital stay were compared. One-way analysis of variance paired t-test and Chi-square test were utilized for statistical analysis. RESULTS: The mean ages of the patients in three groups were 6.03 ± 3.71, 5.69 ± 3.34 and 5.48 ± 3.35 respectively. The 3(rd) day CS scores for all the groups were 1.0 ± 1.1, 1.9 ± 1.1 and 3.3 ± 0.5 respectively (P = 0.000). The average length of hospital stay was 3.4 ± 1.7, 3.7 ± 1.9 and 4.9 ± 1.4 days respectively (P = 0.001). CONCLUSION: The present study concludes that 3% HS nebulization (without additional bronchodilators) is an effective and safe treatment for nonasthmatic, moderately ill patients of acute bronchiolitis. The economic benefit of this comparably priced modality of treatment can be enormous in terms of hospital costs with parents returning to work sooner.

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
Enlaces Pubmed DOI

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

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Comparing the Efficacy of 7%, 3% and 0.9% Saline in Moderate to Severe Bronchiolitis in Infants.

Revista Balkan medical journal
Año 2016
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

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BACKGROUND: There is no standard treatment option in acute bronchiolitis. 3-7% hypertonic saline (HS) seems to be the effective treatment choice for reducing the hospitalization day. AIMS: To compare the effect of nebulized 7% HS/ salbutamol and 3% HS/salbutamol to 0.9% saline/ salbutamol. The primary outcome measure was the effect of study drugs on the length of hospital stay (LOS). Secondary outcome measures were safety and efficacy in reducing the clinical severity score (CSS) at the 24 hours of the study. STUDY DESIGN: Prospective, double-blinded randomized clinical study. METHODS: The study consists of 104 infants. Groups were constituted according to the treatment they received: These are, group A- 0.9% saline/salbutamol, group B -3% HS/salbutamol and group C-7% HS/salbutamol. Heart beat, Bronchiolitis CSS and oxygen saturation of the patients were determined before and after nebulization. The patients were monitored for adverse reactions. RESULTS: Length of hospital stay in group A, B and C were as follows; 72.0 (20-288) hours in group A, 64.0 (12-168) hours in group B and 60.0 (12-264) hours in group C. No significant differences was observed among three groups (p>0.05). CONCLUSION: 7% HS and 3% HS does not have any effect to decrease LOS for infants with bronchiolitis.

Estudio primario

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The clinical use of hypertonic saline/salbutamol in treatment of bronchiolitis

Revista Pediatria Polska
Año 2016
Enlaces DOI http://www.sciencedirect.com/science/article/pii/S0031393916300270

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Aim To compare the efficacy of nebulised 3% saline solution (with salbutamol) or 0.9% saline solution (with salbutamol) in the treatment of mild to moderate bronchiolitis. Methods It was a randomised, double-blind trial. Seventy-eight children (up to 18 month of life) with mild to moderate bronchiolitis hospitalised in Pediatric Unit Hospital of Zdroje were enrolled. The infants received inhalation of salbutamol (0.15 mg/kg, max. 1.5 mg = 1.5 ml) dissolved in 3 ml 3% saline – treatment group (n = 41), or 3 ml 0.9% saline – control group (n = 37). The therapy was repeated six times daily until discharge. The duration of hospital stay and rapidity of clinical improvement were assessed. Results Taking the significance level specified at 0.05 into account, there were no statistically significant differences in the length of hospital stay, with 3.06 ± 1.613 days in the treatment group and 3.11 ± 1.634 days in the control group (p = 0.43). Neither were observed statistically significant differences in clinical severity scores after 24, 48 and 72 h (p24 = 0.192, p48 = 0.425, p72 = 0.220). The positive rate for RSV was 53%. No significant adverse events, such as bronchospasm, were observed. Conclusions Nebulised 3% saline (with salbutamol) is not superior to 0.9% (with salbutamol) in the treatment of mild to moderate bronchiolitis.

Estudio primario

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Analysis of the effect of azithromycin injection for bronchiolitis

Autores Xu Lili
Revista Health Care Guide (养生保健指南)
Año 2016

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Estudio primario

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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

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Randomized trial to evaluate azithromycin's effects on serum and upper airway IL-8 levels and recurrent wheezing in infants with respiratory syncytial virus bronchiolitis.

Revista The Journal of allergy and clinical immunology
Año 2015
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia) 1 Síntesis amplia Síntesis amplias (1 referencia)

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BACKGROUND: Respiratory syncytial virus (RSV) bronchiolitis in infancy is a major risk factor for recurrent wheezing and asthma. Because azithromycin attenuated neutrophilic airway inflammation in a murine viral bronchiolitis model, demonstration of similar effects in human subjects might provide a strategy for the prevention of postbronchiolitis recurrent wheezing. OBJECTIVES: We sought to investigate whether azithromycin treatment during RSV bronchiolitis reduces serum and nasal lavage IL-8 levels and the occurrence of postbronchiolitis recurrent wheezing. METHOD: We performed a randomized, double-masked, placebo-controlled proof-of-concept trial in 40 otherwise healthy infants hospitalized with RSV bronchiolitis who were treated with azithromycin or placebo for 14 days. IL-8 levels were measured in nasal lavage fluid and serum on randomization, day 8, and day 15 (nasal lavage only). The occurrence of wheezing episodes was assessed monthly over the ensuing 50 weeks. RESULTS: Compared with placebo, azithromycin treatment did not reduce serum IL-8 levels at day 8 (P = .6) but resulted in a greater decrease in nasal lavage fluid IL-8 levels by day 15 (P = .03). Twenty-two percent of azithromycin-treated participants experienced at least 3 wheezing episodes compared with 50% of participants in the placebo group (P = .07). Azithromycin treatment resulted in prolonged time to the third wheezing episode (P = .048) and in fewer days with respiratory symptoms over the subsequent year in comparison with placebo (36.7 vs 70.1 days, P = .01). CONCLUSION: In this proof-of-concept study azithromycin treatment during RSV bronchiolitis reduced upper airway IL-8 levels, prolonged the time to the third wheezing episode, and reduced overall respiratory morbidity over the subsequent year.

Estudio primario

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3% Hypertonic Saline Versus Normal Saline in Inpatient Bronchiolitis: A Randomized Controlled Trial.

Revista Pediatrics
Año 2015
Enlaces Pubmed DOI

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BACKGROUND AND OBJECTIVES: Bronchiolitis, the most common reason for hospitalization in children younger than 1 year in the United States, has no proven therapies effective beyond supportive care. We aimed to investigate the effect of nebulized 3% hypertonic saline (HS) compared with nebulized normal saline (NS) on length of stay (LOS) in infants hospitalized with bronchiolitis METHODS: We conducted a prospective, randomized, double-blind, controlled trial in an urban tertiary care children's hospital in 227 infants younger than 12 months old admitted with a diagnosis of bronchiolitis (190 completed the study); 113 infants were randomized to HS (93 completed the study), and 114 to NS (97 completed the study). Subjects received 4 mL nebulized 3% HS or 4 mL 0.9% NS every 4 hours from enrollment until hospital discharge The primary outcome was median LOS. Secondary outcomes were total adverse events, subdivided as clinical worsening and readmissions. RESULTS: Patient characteristics were similar in groups. In intention-to-treat analysis, median LOS (interquartile range) of HS and NS groups was 2.1 (1.2-4.6) vs 2.1 days (1.2-3.8), respectively, P = .73. We confirmed findings with pei -protocol analysis, HS and NS groups with 2.0 (1.3-3.3) and 2.0 days (1.2-3.0), respectively, P = .96. Seven-day readmission rate for HS and NS groups were 4.3% and 3 1%, respectively, P - .77'. Clinical worsening events were similar between groups (9% vs 8%, P = .97). CONCLUSIONS: Among infants admitted to the hospital with bronchiolitis, treatment with nebulized 3% HS compared with NS had no difference in LOS or 7-day readmission rates.

Estudio primario

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Three-weekly doses of azithromycin for indigenous infants hospitalized with bronchiolitis: a multicentre, randomized, placebo-controlled trial.

Revista Frontiers in pediatrics
Año 2015
Enlaces Pubmed DOI PubMed Central

Este artículo está incluido en 3 Revisiones sistemáticas Revisiones sistemáticas (3 referencias)

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BACKGROUND: Bronchiolitis is a major health burden in infants globally, particularly among Indigenous populations. It is unknown if 3 weeks of azithromycin improve clinical outcomes beyond the hospitalization period. In an international, double-blind randomized controlled trial, we determined if 3 weeks of azithromycin improved clinical outcomes in Indigenous infants hospitalized with bronchiolitis. METHODS: Infants aged ≤24 months were enrolled from three centers and randomized to receive three once-weekly doses of either azithromycin (30 mg/kg) or placebo. Nasopharyngeal swabs were collected at baseline and 48 h later. Primary endpoints were hospital length of stay (LOS) and duration of oxygen supplementation monitored every 12 h until judged ready for discharge. Secondary outcomes were: day-21 symptom/signs, respiratory rehospitalizations within 6 months post-discharge and impact upon nasopharyngeal bacteria and virus shedding at 48 h. RESULTS: Two hundred nineteen infants were randomized (n = 106 azithromycin, n = 113 placebo). No significant between-group differences were found for LOS (median 54 h for each group, difference = 0 h, 95% CI: -6, 8; p = 0.8), time receiving oxygen (azithromycin = 40 h, placebo = 35 h, group difference = 5 h, 95% CI: -8, 11; p = 0.7), day-21 symptom/signs, or rehospitalization within 6 months (azithromycin n = 31, placebo n = 25 infants, p = 0.2). Azithromycin reduced nasopharyngeal bacterial carriage (between-group difference 0.4 bacteria/child, 95% CI: 0.2, 0.6; p < 0.001), but had no significant effect upon virus detection rates. CONCLUSION: Despite reducing nasopharyngeal bacterial carriage, three large once-weekly doses of azithromycin did not confer any benefit over placebo during the bronchiolitis illness or 6 months post hospitalization. Azithromycin should not be used routinely to treat infants hospitalized with bronchiolitis. CLINICAL TRIAL REGISTRATION: The trial was registered with the Australian and New Zealand Clinical Trials Register: Clinical trials number: ACTRN1261000036099.