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NCT07202585
Medical practice variability refers to differences in treatment and clinical outcomes that cannot be solely explained by patient characteristics or medical conditions. This variability can lead to inconsistent outcomes, especially in complex environments like pediatric inpatient wards. Standardization of care protocols is proposed as a way to reduce this inconsistency.
NCT05132322
The purpose of this study is to identify the optimal deimplementation strategies for an overused practice: continuous pulse oximetry monitoring of children hospitalized with bronchiolitis who are not receiving supplemental oxygen.
NCT07243652
Although automatic follow-up is a nearly universal practice, research has shown that these visits are often unnecessary after hospitalizations caused by bronchiolitis. Despite endorsement by national pediatric authorities, robust evidence, and family enthusiasm for as-needed (PRN) follow-up, it remains substantially underutilized for children hospitalized for bronchiolitis. The goal of I-DECIDE is to compare the effects of two multi-component implementation strategies, both of which aim to (a) increase PRN follow-up prescribing by hospitalists (physicians who care for hospitalized children) and (b) decrease unnecessary follow-up visit attendance by families.
NCT06177197
The objective of this study is to show that the use of electrodialyzed seawater reduces the duration (in days) of symptoms in acute infant bronchiolitis compared with the use of saline solution in infants aged 1 month to less than one year. B-CLASS study is a multicenter, prospective, controlled, randomized, double label blind.
NCT06689631
To assess the efficacy of mucociliary clearance techniques in non-hospitalised infants with a first episode of mild to moderate acute bronchiolitis.
NCT03280732
Bronchiolitis is the leading cause of hospitalization in infants. The diagnosis is clinical and chest x-ray (CXR) should be reserved for severe cases in which signs of pulmonary complications are present. Nevertheless, CXR is performed in more than 50% of hospitalized patients with bronchiolitis, which exposes infants to ionizing radiation. Data on the possible role of lung ultrasound (LUS) in children with bronchiolitis and suspected pulmonary complications have not been published yet. The purpose of this study is to evaluate the use of LUS compared to CXR in diagnosing and monitoring pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children with acute bronchiolitis. The second purpose of the study is to evaluate the correlation between clinical course and ultrasound findings in children with bronchiolitis. The inclusion of LUS in the diagnostic work-up of bronchiolitis could possibly reduce the misuse of CXR in infants and the exposure to ionizing radiations.
NCT04060979
Prospective, Double-Blinded, Randomized, Multi-Center Study for Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With Bronchiolitis The proposed study judiciously expands these observations for use of NO treatment in pediatric patients with bronchiolitis aged less than 12 months. The intermittent dosing strategy used in this study has been selected to minimize the potential for adverse effects. The inclusion of two doses in the proposed pilot study is intended to determine a dose response effect and select a dose that is optimally safe and effective. The primary endpoint evaluation of time to fit for discharge will provide an effective objective measurement for the treatment effectiveness compared to standard supportive treatment of bronchiolitis. Primary objective: • Assess whether Nitric Oxide (NO) administered intermittently in 2 concentrations (via inhalation for 40 minutes 4 times per day for up to 5 consecutive days) in addition to Standard Supportive Treatment (SST) shortens the recovery time of infants with bronchiolitis, compared to SST alone. Secondary objectives: * Time to achieve O2 saturation of ≥ 92 % sustained for at least 2 hours * Reduction in hospital Length of Stay (LOS) * Time to achieve mTal score of ≤ 5 Safety objectives: Characterize the safety of 2 doses of NO intermittent inhalation treatment therapy as measured by Adverse Events (AE) - number and percentage of subjects that experience AEs - and Serious Adverse Events (SAEs). A total of 90 subjects will be enrolled into the study and randomized in a 1:1:1 ratio to receive the study treatments. Treatment administration: Treatment blindness will be kept by designation of blinded and un-blinded team members.The blinded staff will be performing the study assessment procedures and the un-blinded team will be administering the actual treatment. Subjects' parents/legal guardian will be contacted for a follow up phone call at days 14+5 and 30+5 from the date of enrollment of the subject into the study.
NCT03364218
Bronchiolitis is the major cause of hospital admission in infants \< 6 months of age and usually viruses like Respiratory syncytial virus (RSV), human metapneumo virus, Adeno virus, para-influenza virus, Rhino virus and influenza virus are the main culprit. In the US, acute bronchiolitis in infancy is responsible for approximately 150,000 hospitalizations yearly at an estimated cost of $500 million. Globally in 2005 it was estimated that at least 33.8 million were affected with RSV and in the same year, RSV associated severe acute lower respiratory infection (ALRI) were responsible for \~3.4 million hospitalizations and 66,000-199,000 deaths worldwide, with 99% of these deaths in developing countries. In acute bronchiolitis there is cellular swelling and excessive mucus production. There is also proliferation of goblet cells, which leads to increased mucus production. The excess mucus produced is poorly cleared by non-ciliated (regenerating) epithelial cells leading to areas of narrowing and blocking of the bronchioles, causing the airway obstruction, hyperinflation, increased airway resistance, atelectasis and increased ventilation-perfusion mismatch that characterize acute bronchiolitis. Currently there is no medicine that has proven effective in treating acute bronchiolitis and per American Academy of Pediatrics guidelines the management of acute bronchiolitis remains supportive care for the acute respiratory failure associated with acute bronchiolitis. N-Acetyl Cysteine (NAC) is an antioxidant, anti-mucus compound that increases intracellular glutathione at the cellular level. It cleaves disulfide bonds by converting them to two sulfhydryl groups. This action results in the breakup of mucoproteins in lung mucus, reducing their chain lengths and thinning the mucus. Nebulized NAC is not studied well in acute bronchiolitis and is uncommonly used for the same. NAC has been studied in the treatment of various disease states, including those pulmonary in nature such as cystic fibrosis, chronic bronchitis, non-cystic fibrosis bronchiectasis and found to be beneficial. With this background knowledge, the purpose of this study is to evaluate the effectiveness of nebulized mucolytic therapy in treatment of children with viral bronchiolitis.