Dexamethasone inhalations in RSV bronchiolitis: a double-blind, placebo-controlled study. Prednisolone plus albuterol versus albuterol alone in mild to moderate bronchiolitis. Randomised placebo controlled trial of nebulised corticosteroids in acute respiratory syncytial viral bronchiolitis. Epinephrine and dexamethasone in children with bronchiolitis. [Comparative clinical study of dexamethasone vs. nebulized salbutamol in acute bronchiolitis]. Efficacy of oral dexamethasone in outpatients with acute bronchiolitis. A multicenter, randomized, controlled trial of dexamethasone for bronchiolitis. Long and short-term effect of prednisolone in hospitalized infants with acute bronchiolitis. Additive effects of dexamethasone in nebulized salbutamol or L-epinephrine treated infants with acute bronchiolitis. Efficacy of dexamethasone injection for acute bronchiolitis in hospitalized children: a randomized, double-blind, placebo-controlled trial. Single oral dose of dexamethasone in outpatients with bronchiolitis: a placebo controlled trial. Efficacy of corticosteroids in acute bronchiolitis: short-term and long-term follow-up. Early nebulized budesonide in the treatment of bronchiolitis and the prevention of postbronchiolitic wheezing. Dexamethasone in salbutamol-treated inpatients with acute bronchiolitis: a randomized, controlled trial. Respiratory syncytial virus bronchiolitis: a double-blind dexamethasone efficacy study.
To evaluate the effect of inhaled dexamethasone on hospitalization for respiratory syncytial virus (RSV) bronchiolitis.
                A double-blind, placebo-controlled study compared nebulization of dexamethasone versus nebulization of 0.9% saline. Both groups were treated with epinephrine nebulizations. Follow-up continued for 3 mo.
                Sixty-one infants with bronchiolitis aged 3 to 12 mo were included. They were randomly allocated to nebulizations with 0.25 mg dexamethasone every 6 h (group 1) or an equivalent amount of normal saline (group 2).
                No statistically significant differences with respect to clinical score, oxygen saturation, or IV fluid requirement between the groups were noted. Using Kaplan-Meyer's method, the cumulative proportion of in-hospital stay was significantly lower in group 1 compared with group 2, mainly in days 5 and 6 post-hospitalization (p<0.038). A subgroup of prematurely born children in group 1 had a shorter hospitalization period (6.5+/-1.7 d) compared with group 2 children (9.1+/-1.9) (p<0.018). Follow-up revealed similar wheeze and hospitalization rates in the two groups.
                Inhaled dexamethasone may reduce the length of hospitalization among infants with acute viral bronchiolitis, especially among those born prematurely. To evaluate combination therapy of mild to moderate bronchiolitis with bronchiodilators and corticosteroids, we treated 51 young children with first-time wheezing and symptoms of respiratory tract infection with albuterol plus either prednisolone or placebo for 5 days. Disease severity was scored on days 0, 2, 3, and 6. On day 2, prednisolone resulted in significantly lower scores (2.7 +/- 1.4 vs. 4.0 +/- 1.5 in all patients evaluated, p < 0.05) than placebo, whereas there was no detectable difference on day 6, suggesting that addition of prednisolone to albuterol transiently accelerates recovery from bronchiolitis. The clinical significance of this effect needs to be evaluated in further studies. To evaluate short and long term effects of giving nebulised budesonide early in respiratory syncytial viral (RSV) bronchiolitis.
                A multicentre randomised double blind placebo controlled trial.
                Infants admitted to hospital with their first episode of RSV positive bronchiolitis.
                Randomisation to receive either 1 mg of nebulised budesonide (Bud) or placebo (Pla) twice daily from admission until 2 weeks after discharge. Follow up was for 12 months.
                Duration of hospital admission, time taken to become symptom free, re-admission rates, general practitioner consultation rates, and use of anti-wheeze medication during follow up.
                161 infants were studied. Both arms were similar with respect to initial clinical severity, age, sex, socioeconomic class, and tobacco exposure. Median time from first nebulisation to discharge: Bud and Pla, 2 days. Median number of days for 50% of infants to be symptom free for 48 hours: Bud, 10 days; Pla, 12 days. Respiratory re-admission rates in the 12 month follow up: Bud, 16%; Pla, 18%; median difference (95% confidence interval (CI)), -2 (-14 to 10). Median respiratory related general practitioner attendances: Bud, 4.0; Pla, 4.5; median difference (95% CI), -1 (-2 to 0). Percentage of infants receiving at least one prescription for anti-wheeze medication during follow up, corticosteroids: Bud, 50%; Pla, 60%; difference (95% CI), -10 (-26 to 6); bronchodilators: Bud, 60%; Pla, 67%; difference (95% CI), -7 (-22 to 8).
                There are no short or long term clinical benefits from the administration of nebulised corticosteroids in the acute phase of RSV bronchiolitis. Although numerous studies have explored the benefit of using nebulized epinephrine or corticosteroids alone to treat infants with bronchiolitis, the effectiveness of combining these medications is not well established.
                We conducted a multicenter, double-blind, placebo-controlled trial in which 800 infants (6 weeks to 12 months of age) with bronchiolitis who were seen in the pediatric emergency department were randomly assigned to one of four study groups. One group received two treatments of nebulized epinephrine (3 ml of epinephrine in a 1:1000 solution per treatment) and a total of six oral doses of dexamethasone (1.0 mg per kilogram of body weight in the emergency department and 0.6 mg per kilogram for an additional 5 days) (the epinephrine-dexamethasone group), the second group received nebulized epinephrine and oral placebo (the epinephrine group), the third received nebulized placebo and oral dexamethasone (the dexamethasone group), and the fourth received nebulized placebo and oral placebo (the placebo group). The primary outcome was hospital admission within 7 days after the day of enrollment (the initial visit to the emergency department).
                Baseline clinical characteristics were similar among the four groups. By the seventh day, 34 infants (17.1%) in the epinephrine-dexamethasone group, 47 (23.7%) in the epinephrine group, 51 (25.6%) in the dexamethasone group, and 53 (26.4%) in the placebo group had been admitted to the hospital. In the unadjusted analysis, only the infants in the epinephrine-dexamethasone group were significantly less likely than those in the placebo group to be admitted by day 7 (relative risk, 0.65; 95% confidence interval, 0.45 to 0.95, P=0.02). However, with adjustment for multiple comparisons, this result was rendered insignificant (P=0.07). There were no serious adverse events.
                Among infants with bronchiolitis treated in the emergency department, combined therapy with dexamethasone and epinephrine may significantly reduce hospital admissions. (Current Controlled Trials number, ISRCTN56745572.)
                2009 Massachusetts Medical Society Asess the efficacy of nebulized salbutamol and dexamethasone compared with nebulized salbutamol, in patients with bronchiolitis.
                A blinded clinical trial was performed with 49 patients between 1-18 months diagnosed with bronchiolitis with three days or less of disease evolution. Participant's parents signed an informed consent and patients did not receive prior medication. Patients were randomly assigned to two groups: nebulized salbutamol or salbutamol plus dexamethasone, which they received every four hours during twenty-four hours. We measured heart and respiratory rate; respiratory distress index, oxygen saturation, and Silverman Andersen scores.
                No significant differences were found between groups for treatment response; but the frequency of hospital release at 24 hrs was significant among groups; 75 vs 96 % respectively (p = 0.04).
                The administration of salbutamol plus dexamethasone is more effective in the control of respiratory distress in children with bronchiolitis compared with the use of salbutamol alone. To examine the efficacy of oral dexamethasone in acute bronchiolitis.
                A double-blind randomized, placebo-controlled trial involving 70 children < 24 months old in the emergency department with Respiratory Disease Assessment Instrument > or = 6. Each patient received either 1 dose of 1 mg/kg of oral dexamethasone or placebo and was assessed hourly for a 4-hour period. Repeated measures regression analysis evaluated a change in the Respiratory Assessment Change Score (RACS).
                The 2 groups had similar baseline characteristics with Respiratory Disease Assessment Inventory of 9.4 +/- 2.3 in the dexamethasone group (n = 36) and 10.0 +/- 2.7 in the placebo group (n = 34). The RACS was -5.0 +/- 3.1 in the dexamethasone group and -3.2 +/- 3.7 in the placebo group (P =.029). Poor RACS occurred in 41% and 17% of the placebo and dexamethasone groups, respectively (P =.034). Of the children treated with dexamethasone, 19% were hospitalized compared with 44% in the placebo group (P =.039). There was no difference in RACS between the groups on day 7 (P =.75).
                Outpatients with moderate-to-severe acute bronchiolitis derive significant clinical and hospitalization benefit from oral dexamethasone treatment in the initial 4 hours of therapy. Bronchiolitis, the most common infection of the lower respiratory tract in infants, is a leading cause of hospitalization in childhood. Corticosteroids are commonly used to treat bronchiolitis, but evidence of their effectiveness is limited.
                We conducted a double-blind, randomized trial comparing a single dose of oral dexamethasone (1 mg per kilogram of body weight) with placebo in 600 children (age range, 2 to 12 months) with a first episode of wheezing diagnosed in the emergency department as moderate-to-severe bronchiolitis (defined by a Respiratory Distress Assessment Instrument score > or =6). We enrolled patients at 20 emergency departments during the months of November through April over a 3-year period. The primary outcome was hospital admission after 4 hours of emergency department observation. The secondary outcome was the Respiratory Assessment Change Score (RACS). We also evaluated later outcomes: length of hospital stay, later medical visits or admissions, and adverse events.
                Baseline characteristics were similar in the two groups. The admission rate was 39.7% for children assigned to dexamethasone, as compared with 41.0% for those assigned to placebo (absolute difference, -1.3%; 95% confidence interval [CI], -9.2 to 6.5). Both groups had respiratory improvement during observation; the mean 4-hour RACS was -5.3 for dexamethasone, as compared with -4.8 for placebo (absolute difference, -0.5; 95% CI, -1.3 to 0.3). Multivariate adjustment did not significantly alter the results, nor were differences detected in later outcomes.
                In infants with acute moderate-to-severe bronchiolitis who were treated in the emergency department, a single dose of 1 mg of oral dexamethasone per kilogram did not significantly alter the rate of hospital admission, the respiratory status after 4 hours of observation, or later outcomes. (ClinicalTrials.gov number, NCT00119002 [ClinicalTrials.gov].).
                Copyright 2007 Massachusetts Medical Society. To assess long and short-term effect of prednisolone in hospitalized infants with bronchiolitis.
                A randomized and controlled trial was carried out at the Federal University of Rio Grande, Rio Grande-RS, Brazil. Twenty-eight patients were randomly allocated prednisolone (1 mg/kg/day for 5 days) plus standard care, and 24 patients allocated standard care alone. The primary endpoint was the prevalence of post-bronchiolitis wheezing at 1, 3, 6 and 12 months after hospital discharge. The secondary endpoints were: length of hospital stay, duration of oxygen therapy and time to clinical improvement during the hospitalization.
                There were no significant differences between the prednisolone and control group in the prevalence of post-bronchioltis wheezing at 1 month (73.1 vs 83.3%, P = 0.5), 3 months (73.1 vs 79.2%, P = 0.7), 6 months (65.4 vs 66.7%, P = 0.9) and 12 months (50.0 vs 58.3%, P = 0.5) after hospital discharge. No reduction was observed in the prednisolone group, compared with the control group, in terms of length of hospital stay (6.0 vs 5.0 days, P = 0.7), duration of oxygen therapy (24.0 vs 24.0 h, P = 0.4) and time to clinical resolution (4.0 vs 4.0 days, P = 0.8).
                Prednisolone has no significant effect on reducing the prevalence of post-bronchiolitis wheezing and on improving the acute course of illness in hospitalized infants with bronchiolitis. Although it is the most common lower respiratory infection of infancy, the optimal treatment for acute bronchiolitis is still controversial. The aim of this study was to compare the early and late effects of nebulized L-epinephrine (EPI) and intramuscular dexamethasone (DEX) combination therapy with nebulized salbutamol (SAL) and dexamethasone combination and bronchodilators alone in outpatients with acute bronchiolitis.
                A total of 69 infants aged 2-21 months who were admitted to the Pediatrics Department of the Faculty of Medicine, Mersin University, with acute bronchiolitis were included in a randomized, placebo-controlled, prospective trial study. Patients were assigned to receive either nebulized L-epinephrine (3 mg) or salbutamol (0.15 mg/kg) and 15 min later, either dexamethasone 0.6 mg/kg or placebo (PLA), intramuscularly, in a double-blind randomized fashion. The study groups were: epinephrine + dexamethasone group (group 1, n=23), salbutamol + dexamethasone group (group 2, n=23), epinephrine + placebo group (group 3, n=11), and salbutamol + placebo group (group 4, n=12). The outcome measures were heart rate, respiratory rate and Respiratory Distress Assessment Instrument (RDAI) score determined at 30, 60, 90 and 120 min, 24 h, and 5 days after the first therapy. Patients were then followed-up during the subsequent 2 months for the prevalance of respiratory complaints regarding bronchial hyperreactivity.
                There were no significant differences between the outcome variables of the four groups within the first 120 min and at 24 hours, or between the rates of requirement of a second dose of the same bronchodilator. However, fifth day RDAI score values of both DEX groups were significantly lower than that of SAL + PLA group (P=0.000 and P=0.01, respectively). The fifth day score value of group 1 was also significantly better than that value of EPI + PLA group but not different from group 2.
                A single dose of intramuscular dexamethasone added to nebulized L-epinephrine, or salbutamol therapies resulted in better outcome measures than bronchodilators alone in the late phase (fifth day) of mild to moderate degree bronchiolitis attack. However, effects of EPI + DEX combination was not different from SAL + DEX combination. Controversy over the efficacy of systemic corticosteroids for acute bronchiolitis initiated this study. We conducted a randomized, double-blind, placebo-controlled trial to examine the efficacy of single dexamethasone injection for the treatment of acute bronchiolitis in young hospitalized children. The study, performed at the pediatric wards of a University Hospital and its affiliated hospital in Thailand, included 174 previously healthy children under 2 years of age, hospitalized with acute bronchiolitis. Each child received either a single intramuscular injection of 0.6 mg/kg dexamethasone or a placebo in addition to regular management. The primary outcome was the time from study entry to resolution of respiratory distress, determined by a clinical score derived from the respiratory rate, occurrence of wheezing, chest retraction, and oxygen saturation. Survival analysis using the Kaplan-Meier method and a log-rank test were performed. A single-dose, dexamethasone injection versus placebo produced a significant: (1) decrease in the time needed for resolution of respiratory distress (hazard ratio 1.56; 95% CI, 1.14-2.13; P = 0.005), (2) decrease in the mean duration of symptoms of 11.8 hr (95% CI, 3.9-19.7; P = 0.004), (3) decrease in the mean duration of oxygen therapy of 14.9 hr (95% CI, 5.3-24.4; P = 0.003), and (4) decrease in the mean length of hospital stay of 13.4 hr (95%CI, 2.6-24.2; P = 0.02). In conclusion, a single injection of dexamethasone yielded a significant clinical benefit for the treatment of previously healthy, young children hospitalized with acute bronchiolitis.
                Copyright 2007 Wiley-Liss, Inc. The management of bronchiolitis is still controversial and to the best of our knowledge, no clinical trial with oral corticosteroids in outpatients has been carried out in developing countries. The objective was to compare the efficacy of a single dose of oral dexamethasone in infants with moderate to severe bronchiolitis presenting to an emergency department.
                A randomised, double-blind, placebo-controlled trial was conducted in Paraguay. At baseline, respiratory distress assessment instrument (RDAI), heart and respiratory rates, and transcutaneous haemoglobin oxygen saturation (SpO(2)) were recorded. Children received either a single dose of dexamethasone (0.5 mg/kg) or placebo; and then both groups received two nebulisations with adrenaline. Respiratory status was recorded again after the 1st and 4th hours. The primary outcome was RDAI improvement at the 4th hour; and the secondary was the hospital admission rate.
                During 5 months, 80 (33.3 %) out of 240 infants who consulted with acute respiratory illness fulfilled the inclusion criteria. During the trial 15 were excluded, therefore, 65 infants (33 in the dexamethasone vs. 32 in the placebo group) finished the study. Baseline characteristics and respiratory status were similar between groups. There were no differences in RDAI, heart and respiratory rate and SpO(2) between groups after the 1st and 4th hours. The hospitalisation rate was similar between groups (21 % vs. 25 %, p = 0.9, respectively), independently of the virus identified.
                Infants with moderate-severe bronchiolitis who were treated with a single dose of dexamethasone did not significantly alter the rate of hospitalisation or respiratory status. Corticosteroids continue to be used by many physicians to treat infants with bronchiolitis. The aim of this study was to examine the short-term and long-term efficacy of oral corticosteroid therapy when added to beta2-agonists in infants with mild to moderate bronchiolitis (defined as the first episode of wheezing associated with low grade fever, rhinitis, tachypnea, and increased respiratory effort in a previously healthy infant during the winter months). Infants with mild to moderate bronchiolitis, were randomly assigned to receive either oral prednisone (2 mg/kg/day) or placebo for 3 days. All patients received nebulized albuterol q.i.d. during this period. Upon admission and after 3 days of therapy, a clinical score was assigned based on respiratory rate, use of accessory muscle, and the presence of wheeze. Oxygen saturation (SaO2) was also measured. On day 7, we inquired as to the well-being of each child. Two years later, the development of chronic respiratory symptoms was assessed. Thirty-eight infants were enrolled in the study; 20 received prednisone and 18 received placebo. Both groups were similar in terms of age, duration of illness prior to enrollment, pretrial medication use, clinical severity of bronchiolitis, history of atopy, and family history of atopy. After 3 and 7 days of treatment, both groups showed similar clinical improvement and there were no statistically significant differences between the two groups in the clinical score or in the SaO2. No major side effects were observed. Two years later, 32% of the infants continued to suffer from chronic respiratory symptoms, with a similar prevalence in both groups. We conclude that a 3-day course of oral corticosteroids is of no benefit to infants with mild to moderate bronchiolitis who are also treated with an inhaled beta2-agonist. To determine the effectiveness of nebulized budesonide in the treatment of acute bronchiolitis and in the prevention of postbronchiolitic wheezing.
                A randomized, double-blind, placebo-controlled trial was performed.
                Forty infants with bronchiolitis (83% RSV), mean age 13.5 weeks (range 4 to 41 weeks), were admitted to the Royal Alexandra Children's Hospital, Brighton, UK.
                Twenty-one infants received nebulized budesonide 1 mg every 12 hours for 5 days, then 500 micrograms every 12 hours continuing to a total of 6 weeks. Nineteen received nebulized placebo (0.9% saline) for 6 weeks. A clinical scoring system was used to rate acute symptoms, and diary cards were used to assess persistent respiratory symptoms over a 6-month follow-up period.
                No significant differences were found between the budesonide and placebo groups in change in clinical score 48 hours after trial entry, mean oxygen requirements, or length of hospital stay during the acute illness. At 6-month follow-up, the two groups did not differ significantly in prevalence of wheeze, respiratory symptom scores, or proportion requiring bronchodilators or steroids.
                This study did not demonstrate that a 6-week course of nebulized budesonide reduced the symptoms of acute bronchiolitis or prevented postbronchiolitic wheezing. To determine the clinical benefit of oral dexamethasone in children admitted to the hospital with bronchiolitis treated with nebulized salbutamol.
                Randomized, double-blind, placebo-controlled trial in the inpatient wards of a pediatric tertiary care hospital. The participants, children aged 6 weeks to 15 months, admitted with first-time wheezing, were eligible if their oxygen saturation was less than 95% on admission to the hospital and their Respiratory Distress Assessment Instrument (RDAI) score was greater than 6. Patients were excluded if they had any one of the following: an underlying disease that might affect cardiopulmonary status, asthma, recent treatment with steroids (within 2 weeks), or any history of adverse reaction to steroids. Patients were randomly assigned to receive either orally administered dexamethasone with 0.5 mg/kg as the first dose and 0.3 mg/kg for the next 2 mornings, or an equal volume of an orally administered placebo with an identical appearance. All patients received nebulized salbutamol at 0.15 mg/kg every 4 hours for the first 24 hours. The primary outcome measure was the change from baseline in the RDAI score at 24 hours. Secondary outcome measures were oxygen saturation, respiratory rate, RDAI measurement twice daily for the first 4 days, and the length of hospitalization.
                At 24 hours the mean change (SD) from baseline in the RDAI score was 1.6 (2.3) in the placebo group (n = 28) and 1.4 (2.0) in the dexamethasone group (n = 33; p = 0.74). There were no significant differences between the two groups in change in oxygen saturation, respiratory rate, and RDAI score at any assessment period. The median length of stay (95% confidence interval) for the placebo group was 48 (42, 54) hours compared with 57 (38, 76) hours in the dexamethasone group (p = 0.19).
                Oral dexamethasone therapy does not affect the clinical course of children hospitalized with bronchiolitis and therefore cannot be recommended in this clinical situation. The efficacy of dexamethasone therapy for primary respiratory syncytial virus bronchiolitis was studied in a double-blind placebo design in 29 previously healthy infants (median age, 194 days). No significant differences were found between the groups in evolution of respiratory rate, oxygen saturation, clinical score, or pulmonary function tests on day 3.