Three-weekly doses of azithromycin for indigenous infants hospitalized with bronchiolitis: a multicentre, randomized, placebo-controlled trial.
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ABSTRACT:
SUBMITTER: McCallum GB
PROVIDER: S-EPMC4404864 | biostudies-other | 2015
REPOSITORIES: biostudies-other
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Three-weekly doses of azithromycin for indigenous infants hospitalized with bronchiolitis: a multicentre, randomized, placebo-controlled trial.
McCallum Gabrielle B GB Morris Peter S PS Grimwood Keith K Maclennan Carolyn C White Andrew V AV Chatfield Mark D MD Sloots Theo P TP Mackay Ian M IM Smith-Vaughan Heidi H McKay Clare C CC Versteegh Lesley A LA Jacobsen Nerida N Mobberley Charmaine C Byrnes Catherine A CA Chang Anne B AB
Frontiers in pediatrics 20150421
<h4>Background</h4>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.<h4>Methods</h4>Infants aged ≤24 months were enrolled from three centers and randomized to ...[more]
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Project description:BackgroundHospitalized bronchiolitis imposes a significant burden among infants, particularly among Indigenous children. Traditional or known risk factors for severe disease are well described, but there are limited data on risks for prolonged hospitalization and persistent symptoms. Our aims were to determine factors (clinical and microbiological) associated with (i) prolonged length of stay (LOS); (ii) persistent respiratory symptoms at 3 weeks; (iii) bronchiectasis up to ∼24 months post-hospitalisation; and (iv) risk of respiratory readmissions within 6 months.MethodsIndigenous infants hospitalized with bronchiolitis were enrolled at Royal Darwin Hospital between 2008 and 2013. Standardized forms were used to record clinical data. A nasopharyngeal swab was collected at enrolment to identify respiratory viruses and bacteria.ResultsThe median age of 232 infants was 5 months (interquartile range 3-9); 65% male. On multivariate regression, our 12 point severity score (including accessory muscle use) was the only factor associated with prolonged LOS but the effect was modest (+3.0 hr per point, 95%CI: 0.7, 5.1, P = 0.01). Presence of cough at 3 weeks increased the odds of bronchiectasis (OR 3.0, 95%CI: 1.1, 7.0, P = 0.03). Factors associated with respiratory readmissions were: previous respiratory hospitalization (OR 2.3, 95%CI: 1.0, 5.4, P = 0.05) and household smoke (OR 2.6, 95%CI: 1.0, 6.3, P = 0.04).ConclusionIncreased severity score is associated with prolonged LOS in Indigenous children hospitalized with bronchiolitis. As persistent symptoms at 3 weeks post-hospitalization are associated with future diagnosis of bronchiectasis, optimising clinical care beyond hospitalization is needed to improve long-term respiratory outcomes for infants at risk of respiratory disease. Pediatr Pulmonol. 2016;51:613-623. © 2015 Wiley Periodicals, Inc.
| S-EPMC7167668 | biostudies-literature
Project description:ObjectiveTo investigate the relationship between socioeconomic factors and bronchiolitis severity among hospitalized infants.MethodsWe performed a 17-center, prospective cohort study from 2011 to 2014. Children <1 year old hospitalized with bronchiolitis were enrolled. Socioeconomic factors included estimated median household income (MHI) per home ZIP code, parent-reported household income, number of adults and children in household, and insurance type. We defined higher bronchiolitis severity as receipt of intensive care treatment. Multivariable logistic regression was used to analyze the association between socioeconomic factors and bronchiolitis severity, with the final model adjusted for potential clustering by site.ResultsIn multivariable models adjusted for demographic and clinical characteristics, estimated MHI was the socioeconomic factor most strongly associated with severity. Compared to infants with an intermediate MHI ($40,000-$79,999), odds of receiving intensive care treatment were significantly higher for those with MHI of ≥$80,000 (aOR 2.05, 95% CI 1.19-3.53). No significant associations were found for the other socioeconomic factors (all P > .30). While there were no significant differences in clinical presentation between income groups (all P > .25) or in receipt of mechanical ventilation alone (P = .98), infants with estimated MHI ≥$80,000 were significantly more likely to specifically have been admitted to the intensive care unit (P = .01).ConclusionsIn this multicenter study of infants hospitalized with bronchiolitis, we identified higher median household income as a risk factor for intensive care treatment. This work may yield important biological or nonbiological insights for the future management of infants with bronchiolitis.
| S-EPMC6930979 | biostudies-literature
Project description:Acute bronchiolitis treatment in children and infants is largely supportive, but chest physiotherapy is routinely performed in some countries. In France, national guidelines recommend a specific type of physiotherapy combining the increased exhalation technique (IET) and assisted cough (AC). Our objective was to evaluate the efficacy of chest physiotherapy (IET + AC) in previously healthy infants hospitalized for a first episode of acute bronchiolitis.We conducted a multicenter, randomized, outcome assessor-blind and parent-blind trial in seven French pediatric departments. We recruited 496 infants hospitalized for first-episode acute bronchiolitis between October 2004 and January 2008. Patients were randomly allocated to receive from physiotherapists three times a day, either IET + AC (intervention group, n=246) or nasal suction (NS, control group, n=250). Only physiotherapists were aware of the allocation group of the infant. The primary outcome was time to recovery, defined as 8 hours without oxygen supplementation associated with minimal or no chest recession, and ingesting more than two-thirds of daily food requirements. Secondary outcomes were intensive care unit admissions, artificial ventilation, antibiotic treatment, description of side effects during procedures, and parental perception of comfort. Statistical analysis was performed on an intent-to-treat basis. Median time to recovery was 2.31 days, (95% confidence interval [CI] 1.97-2.73) for the control group and 2.02 days (95% CI 1.96-2.34) for the intervention group, indicating no significant effect of physiotherapy (hazard ratio [HR]=1.09, 95% CI 0.91-1.31, p=0.33). No treatment by age interaction was found (p=0.97). Frequency of vomiting and transient respiratory destabilization was higher in the IET + AC group during the procedure (relative risk [RR]=10.2, 95% CI 1.3-78.8, p=0.005 and RR=5.4, 95% CI 1.6-18.4, p=0.002, respectively). No difference between groups in bradycardia with or without desaturation (RR=1.0, 95% CI 0.2-5.0, p=1.00 and RR=3.6, 95% CI 0.7-16.9, p=0.10, respectively) was found during the procedure. Parents reported that the procedure was more arduous in the group treated with IET (mean difference=0.88, 95% CI 0.33-1.44, p=0.002), whereas there was no difference regarding the assessment of the child's comfort between both groups (mean difference=-0.07, 95% CI -0.53 to 0.38, p=0.40). No evidence of differences between groups in intensive care admission (RR=0.7, 95% CI 0.3-1.8, p=0.62), ventilatory support (RR=2.5, 95% CI 0.5-13.0, p=0.29), and antibiotic treatment (RR=1.0, 95% CI 0.7-1.3, p=1.00) was observed.IET + AC had no significant effect on time to recovery in this group of hospitalized infants with bronchiolitis. Additional studies are required to explore the effect of chest physiotherapy on ambulatory populations and for infants without a history of atopy.ClinicalTrials.gov NCT00125450.
| S-EPMC2946956 | biostudies-literature
Project description:ImportanceThere is low level of evidence and substantial practice variation regarding the use of intermittent or continuous monitoring in infants hospitalized with bronchiolitis.ObjectiveTo compare the effect of intermittent vs continuous pulse oximetry on clinical outcomes.Design, setting, and participantsThis multicenter, pragmatic randomized clinical trial included infants 4 weeks to 24 months of age who were hospitalized with bronchiolitis from November 1, 2016, to May 31, 2019, with or without supplemental oxygen after stabilization at community and children's hospitals in Ontario, Canada.InterventionsIntermittent (every 4 hours, n = 114) or continuous (n = 115) pulse oximetry, using an oxygen saturation target of 90% or higher.Main outcomes and measuresThe primary outcome was length of hospital stay from randomization to discharge. Secondary outcomes included length of stay from inpatient unit admission to discharge and outcomes measured from randomization: medical interventions, safety (intensive care unit transfer and revisits), parent anxiety and workdays missed, and nursing satisfaction.ResultsAmong 229 infants enrolled (median [IQR] age, 4.0 [2.2-8.5] months; 136 [59.4%] male; 101 [44.1%] from community hospital sites), the median length of hospital stay from randomization to discharge was 27.6 hours (interquartile range [IQR], 18.8-49.6 hours) in the intermittent group and 25.4 hours (IQR, 18.3-47.6 hours) in the continuous group (difference of medians, 2.2 hours; 95% CI, -1.9 to 6.3 hours; P = .17). No significant differences were observed between the intermittent and continuous groups in the median length of stay from inpatient unit admission to discharge: 49.1 (IQR, 37.2-87.0) hours vs 46.0 (IQR, 32.5-73.8) hours (P = .13) or in frequencies or durations of hospital interventions, such as oxygen supplementation initiation: 4 of 114 (3.5%) vs. 9 of 115 (7.8%) (P = .16) and median duration of oxygen supplementation: 20.6 (IQR, 7.6-46.1) hours vs. 21.4 (11.6-52.9) hours (P = .66). Similarly, there were no significant differences in frequencies of intensive care unit transfer: 1 of 114 (0.9%) vs 2 of 115 (2.7%) (P = .76); readmission to hospital: 3 of 114 (2.6%) in the intermittent group vs 4 of 115 (3.5%) in the continuous group (P > .99); parent anxiety: mean (SD) parent anxiety score, 2.9 (0.9) in the intermittent group vs 2.8 (0.9) in the continuous group (P = .40); or parent workdays missed: median workdays missed, 1.5 (IQR, 0.5-3.0) vs 1.5 (IQR, 0.5-2.5) (P = .36). Mean (SD) nursing satisfaction with monitoring was significantly greater in the intermittent group: 8.6 (1.7) vs 7.1 (2.8) of 10 workdays; the mean difference was 1.5 (95% CI, 0.9-2.2; P < .001).Conclusions and relevanceIn this randomized clinical trial, among infants hospitalized with stabilized bronchiolitis with and without hypoxia and managed using an oxygen saturation target of 90% or higher, clinical outcomes, including length of hospital stay and safety, were similar with intermittent vs continuous pulse oximetry. Nursing satisfaction was greater with intermittent monitoring. Given that other important clinical practice considerations favor less intense monitoring, these findings support the standard use of intermittent pulse oximetry in stable infants hospitalized with bronchiolitis.Trial registrationClinicalTrials.gov Identifier: NCT02947204.
| S-EPMC7922227 | biostudies-literature
Project description:IMPORTANCE:Hospitalizations of infants for bronchiolitis are common and costly. Despite the high incidence and resource burden of bronchiolitis, the mainstay of treatment remains supportive care, which frequently includes nasal suctioning. OBJECTIVE:To examine the association between suctioning device type and suctioning lapses greater than 4 hours within the first 24 hours after hospital admission on length of stay (LOS) in infants with bronchiolitis. DESIGN:Retrospective cohort study. Data were extracted from the electronic health record. SETTING:Main hospital and satellite facility of a large quaternary care children's hospital from January 10, 2010, through April 30, 2011. PARTICIPANTS:A total of 740 infants aged 2 to 12 months and hospitalized with bronchiolitis. MAIN OUTCOME MEASURE:Hospital LOS. RESULTS:In the multivariable model adjusted for inverse weighting for propensity to receive deep suctioning, increased deep suction as a percentage of suction events was associated with increased LOS with a geometric mean of 1.75 days (95% CI, 1.56-1.95 days) in patients with no deep suction and 2.35 days (2.10-2.62 days) in patients with more than 60% deep suction. An increased number of suctioning lapses was also associated with increased LOS in a dose-dependent manner with a geometric mean of 1.62 days (95% CI, 1.43-1.83 days) in patients with no lapses and 2.64 days (2.30-3.04 days) in patients with 3 or 4 lapses. CONCLUSIONS AND RELEVANCE:For patients admitted with bronchiolitis, the use of deep suctioning in the first 24 hours after admission and lapses greater than 4 hours between suctioning events were associated with longer LOS.
| S-EPMC6291830 | biostudies-literature
Project description:ImportanceHIV-associated chronic lung disease (HCLD) in children is associated with small airways disease, is common despite antiretroviral therapy (ART), and is associated with substantial morbidity. Azithromycin has antibiotic and immunomodulatory activity and may be effective in treating HCLD through reducing respiratory tract infections and inflammation.ObjectiveTo determine whether prophylactic azithromycin is effective in preventing worsening of lung function and in reducing acute respiratory exacerbations (AREs) in children with HCLD taking ART.Design, setting, and participantsThis double-blind, placebo-controlled, randomized clinical trial (BREATHE) was conducted between 2016 and 2019, including 12 months of follow-up, at outpatient HIV clinics in 2 public sector hospitals in Malawi and Zimbabwe. Participants were randomized 1:1 to intervention or placebo, and participants and study personnel were blinded to treatment allocation. Participants included children aged 6 to 19 years with perinatally acquired HIV and HCLD (defined as forced expiratory volume in 1 second [FEV1] z score < -1) who were taking ART for 6 months or longer. Data analysis was performed from September 2019 to April 2020.InterventionOnce-weekly oral azithromycin with weight-based dosing, for 48 weeks.Main outcomes and measuresAll outcomes were prespecified. The primary outcome was the mean difference in FEV1 z score using intention-to-treat analysis for participants seen at end line. Secondary outcomes included AREs, all-cause hospitalizations, mortality, and weight-for-age z score.ResultsA total of 347 individuals (median [interquartile range] age, 15.3 [12.7-17.7] years; 177 boys [51.0%]) were randomized, 174 to the azithromycin group and 173 to the placebo group; 162 participants in the azithromycin group and 146 placebo group participants had a primary outcome available and were analyzed. The mean difference in FEV1 z score was 0.06 (95% CI, -0.10 to 0.21; P = .48) higher in the azithromycin group than in the placebo group, a nonsignificant difference. The rate of AREs was 12.1 events per 100 person-years in the azithromycin group and 24.7 events per 100 person-years in the placebo groups (hazard ratio, 0.50; 95% CI, 0.27 to 0.93; P = .03). The hospitalization rate was 1.3 events per 100 person-years in the azithromycin group and 7.1 events per 100 person-years in the placebo groups, but the difference was not significant (hazard ratio, 0.24; 95% CI, 0.06 to 1.07; P = .06). Three deaths occurred, all in the placebo group. The mean weight-for-age z score was 0.03 (95% CI, -0.08 to 0.14; P = .56) higher in the azithromycin group than in the placebo group, although the difference was not significant. There were no drug-related severe adverse events.Conclusions and relevanceIn this randomized clinical trial specifically addressing childhood HCLD, once-weekly azithromycin did not improve lung function or growth but was associated with reduced AREs; the number of hospitalizations was also lower in the azithromycin group but the difference was not significant. Future research should identify patient groups who would benefit most from this intervention and optimum treatment length, to maximize benefits while reducing the risk of antimicrobial resistance.Trial registrationClinicalTrials.gov Identifier: NCT02426112.
| S-EPMC7747021 | biostudies-literature
Project description: Not available
| S-EPMC5385272 | biostudies-literature
Project description:BackgroundBronchiolitis is the leading cause of infant hospitalizations in the United States. Growing evidence supports the heterogeneity of bronchiolitis. However, little is known about the interrelationships between major respiratory viruses (and their species), host systemic metabolism, and disease pathobiology.MethodsIn an ongoing multicenter prospective cohort study, we profiled the serum metabolome in 113 infants (63 RSV-only, 21 RV-A, and 29 RV-C) hospitalized with bronchiolitis. We identified serum metabolites that are most discriminatory in the RSV-RV-A and RSV-RV-C comparisons using sparse partial least squares discriminant analysis. We then investigated the association between discriminatory metabolites with acute and chronic outcomes.ResultsIn 113 infants with bronchiolitis, we measured 639 metabolites. Serum metabolomic profiles differed in both comparisons (Ppermutation < 0.05). In the RSV-RV-A comparison, we identified 30 discriminatory metabolites, predominantly in lipid metabolism pathways (eg, sphingolipids and carnitines). In multivariable models, these metabolites were significantly associated with the risk of clinical outcomes (eg, tricosanoyl sphingomyelin, OR for recurrent wheezing at age of 3 years = 1.50; 95% CI: 1.05-2.15). In the RSV-RV-C comparison, the discriminatory metabolites were also primarily involved in lipid metabolism (eg, glycerophosphocholines [GPCs], 12,13-diHome). These metabolites were also significantly associated with the risk of outcomes (eg, 1-stearoyl-2-linoleoyl-GPC, OR for positive pressure ventilation use during hospitalization = 0.47; 95% CI: 0.28-0.78).ConclusionRespiratory viruses and their species had distinct serum metabolomic signatures that are associated with differential risks of acute and chronic morbidities of bronchiolitis. Our findings advance research into the complex interrelations between viruses, host systemic response, and bronchiolitis pathobiology.
| S-EPMC7704725 | biostudies-literature
Project description:ImportancePulse oximetry is a noninvasive technology that is integral to the supportive care of hospitalized infants with bronchiolitis. A multicenter, randomized trial comparing the effectiveness of intermittent vs continuous pulse oximetry found similar length of hospital stay and safety outcomes, and greater nursing satisfaction, with intermittent monitoring.ObjectivesTo evaluate the cost-effectiveness of intermittent vs continuous pulse oximetry in hospitalized infants with stabilized bronchiolitis.Design, setting, and participantsAn economic evaluation concurrent with a randomized trial in community and tertiary children's hospitals in Ontario, Canada, was conducted using a probabilistic analysis. Patients were enrolled from November 1, 2016, to May 31, 2019. Data included infants aged 4 weeks to 24 months hospitalized with bronchiolitis, with or without supplemental oxygen, after stabilization. The cost-effectiveness analysis adopted a societal and health care system perspective and a time horizon from hospitalization to 15 days post-discharge. Patient level direct health care costs and indirect costs were included. Health resource use, costs, and clinical outcomes were obtained from trial data. Publicly available pricing resources were used to supplement costs. Ranges for sensitivity analysis were based on 95% confidence intervals of the trial data. All costs were reported in 2021 Canadian dollars.InterventionsIntermittent (every 4 hours) vs continuous pulse oximetry using an oxygen saturation target of 90% or higher.Main outcomes and measuresCosts and incremental costs.ResultsTrial data from 229 infants (median [IQR] age, 4.0 [2.2-8.5] months; 136 boys [59.4%], 93 girls [40.6%]) were included. Mean societal costs per patient were $6879 (95% CI, $3393 to $12 317) in the intermittent and $7428 (95% CI, $1743 to $25 011) in the continuous group with a mean incremental cost of -$548 (95% CI, -$18 486 to $8105). Mean health care system costs per patient were $4195 (95% CI, $1191 to $9461) in the intermittent and $4716 (95% CI, $335 to $22 093) in the continuous group (incremental cost, -$520; 95% CI, -$18 286 to $7358). The mean effect measure of length of stay was similar between the 2 groups: 37.4 hours (95% CI, 1.0 to 137.7 hours) in the intermittent group and 38.5 hours (95% CI, 0 to 237.1 hours) in the continuous group. One-way sensitivity analyses on all variables revealed that the findings were robust and the incremental costs were not sensitive to the uncertainty within the defined ranges.Conclusions and relevanceIn this prospective economic evaluation study, we found that costs were similar for intermittent and continuous pulse oximetry considering societal and health care perspectives. Given that clinical outcomes between monitoring strategies are comparable and that other practice considerations favor intermittent monitoring, these findings provide additional information that support the use of intermittent monitoring in hospitalized infants with stabilized bronchiolitis.
| S-EPMC9685487 | biostudies-literature
Project description:AimAcute bronchiolitis is the commonest cause for hospitalisation in infancy. Supportive care remains the cornerstone of current management and no other therapy has been shown to influence the course of the disease. It has been suggested that adding nebulised hypertonic saline to usual care may shorten the duration of hospitalisation. To determine whether hypertonic saline does have beneficial effects we undertook an open, multi-centre parallel-group, pragmatic RCT in ten UK hospitals.MethodsInfants admitted to hospital with a clinical diagnosis of acute bronchiolitis and requiring oxygen therapy were randomised to receive usual care alone or nebulised 3% hypertonic saline (HS) administered 6-hourly. Randomisation was within 4 h of admission. The primary outcome was time to being assessed as 'fit' for discharge with secondary outcomes including time to discharge, incidence of adverse events together with follow up to 28 days assessing patient centred health related outcomes.ResultsA total of 317 infants were recruited to the study. 158 infants were randomised to HS (141 analysed) and 159 to standard care (149 analysed). There was no difference between the two arms in time to being declared fit for discharge (hazard ratio: 0-95, 95% CI: 0.75-1.20) nor to actual discharge (hazard ratio: 0.97, 95% CI: 0.76-1.23). There was no difference in adverse events. One infant in the HS group developed bradycardia with desaturation.ConclusionThis study does not support the use of nebulised HS in the treatment of acute bronchiolitis over usual care with minimal handlings.Clinicaltrialsgov registration numberNCT01469845.
| S-EPMC4251206 | biostudies-literature