Nebulized Hypertonic Saline for Bronchiolitis
BronchiolitisThis study aims to examine the effect of nebulized 3% hypertonic saline in the treatment of viral bronchiolitis. The investigators hypothesize that nebulized 3% saline will decrease rate of hospital admission, decrease clinical severity scores, and decrease length of stay.
PK Study in 3- to 6- Month-Old Children (0476-268)(COMPLETED)
BronchiolitisThe purpose of this study is to look at the preliminary safety profile of an investigational drug in children 3 to 6 months of age with bronchiolitis.
Single Dose Versus Multiple Doses of Dexamethasone in Children With Acute Bronchiolitis
BronchiolitisThis study is to determine the effectiveness of five-day treatment versus a single dose of oral dexamethasone (corticosteroid) in children between 2 and 24 months of age with a first episode of acute bronchiolitis presenting in the Emergency Department
Montelukast in Acute RSV Bronchiolitis
BronchiolitisThere is evidence of inflammatory mechanisms in RSV bronchiolitis with increased cysteinyl-leukotrienes (cys-LT). Recently, specific cys-LT receptor antagonists - montelukast (Singulair©) approved for use in infants as granule sachets, have become available. We evaluated the effect of Singulair© on clinical progress and on cytokine profiles in the acute phase of RSV bronchiolitis.
Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for...
COPDEmphysema1 moreThe study will evaluate the efficacy and safety of basiliximab Vs placebo as induction therapy combined with standard triple immunosuppression therapy, in the prevention of acute rejection episodes and prevention of Bronchiolitis Obliterans Syndrome.
Evaluation of Two Doses of Nitric Oxide (NO) Given Intermittently Via Inhalation to Subjects With...
Bronchiolitis AcuteProspective, 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.
Vitamin D Supplementation for Acute Bronchiolitis
BronchiolitisThis study was conducted to evaluate the effect of oral vitamin D supplementation on the clinical course of acute bronchiolitis, and to investigate whether vitamin D deficiency among infants who required hospital-based care for bronchiolitis is associated with the severity of the acute episode.
Comparison of the Bulb Aspirator to a Nasal Oral Aspirator in the Treatment of Bronchiolitis
BronchiolitisAspiratorThe investigators aim to compare the standard bulb aspirator with that of a nasal oral aspirator. The hypothesis is that use of a nasal oral aspirator is more effective at removing nasal secretions in the treatment of bronchiolitis as measured by a predicted 50% decrease in the rate of unscheduled bronchiolitis return visits. The primary endpoint will be the number of unscheduled bronchiolitis return visits; secondary endpoints will include measurements of oral intake, respiratory relief, parental device preference and adverse events.
The Effect of Reflexology in Patients With Viral Bronchiolitis
Bronchiolitis; ChemicalReflexologyTo test the influence of reflexology on bronchiolitis.
Evaluation of the Efficacy Safety and Tolerability of Nitric Oxide Given Intermittently Via Inhalation...
BronchiolitisDouble blind, randomized multi-center, evaluation of the efficacy, safety and tolerability of Nitric Oxide (NO) given intermittently via inhalation to subjects with acute bronchiolitis. Bronchiolitis is defined as an infection of the small airways. It is also the most common manifestation of acute lower respiratory infection (ALRI) in early infancy, and is the leading cause of global child mortality. Nitric Oxide (NO) has been shown to play a critical role in various biological functions, including in the vasodilatation of smooth muscle, neurotransmission, regulation of wound healing and during immune responses to infection with a microbicidal action directed toward various organisms. In the airways, NO is considered to play a key role in the innate immune system in which the first-line of host defense against microbes is built. The beneficial effect of NO has been shown in different diseases with several options of doses and regimens; newborn with primary pulmonary hypertension showed improvement in oxygenation after 30 minutes of NO treatment at 10-20 ppm, while subjects with adult respiratory distress syndrome demonstrated clinical improvement during NO treatment at 18 and 36 ppm. In vitro studies suggested that NO, in part per million (ppm) concentrations, possesses antimicrobial and anti-viral activity against a wide variety of phyla including bacteria, viruses, helminthes and parasites. Safety and tolerability of 160 ppm NO given intermittently via inhalation were shown in a phase II study performed on 2-12 month infants hospitalized with bronchiolitis. According to data no difference in the proportion of adverse events and serious adverse events were detected between subjects treated with NO and subjects treated with standard supportive treatment. In this study the investigators wish to assess the efficacy of 160 ppm NO given intermittently via inhalation to 0-12 months-old infants hospitalized due to acute bronchiolitis. Primary objective: Asses the difference in hospital Length of Stay (LOS) between subjects treated with 160 ppm NO combined with standard supportive treatment and subjects treated with standard supportive treatment. Secondary objectives: Asses the difference in the time required to achieve clinical improvement, a clinical score ≤5 (Modified Tal score) between subjects treated with 160 ppm NO combined with standard supportive treatment and subjects treated with standard supportive treatment. Assess the difference in the time required to achieve sustained 92% oxygen saturation in room air between subjects treated with 160 ppm NO combined with standard supportive treatment and subjects treated with standard supportive treatment. Characterize the safety and tolerability of 160 ppm NO intermittent inhalation treatment as measure by the rate of adverse events. In this prospective double-blind, randomized multi-Center study the investigators will enroll up to 120 (no less than 80) subjects aged 0-12 months-old, diagnosed with acute bronchiolitis and requiring in-patient hospitalization. Enrolled subjects will be randomized into 2 groups. Group 1 -Treatment group - Will receive 160 ppm NO given intermittent via inhalation in addition to standard treatment for up to 5 days. Group 2 - will receive ongoing inhalation of the standard treatment for up to 5 days. Between study and after completing all study inhalations the subject will continue to receive the standard treatment. Oxygen (O2), NO, nitrogen dioxide (NO2) and fraction of inspired oxygen (FiO2) delivered to the patient will be continuously monitored. Treatment administration: Treatment blindness will be kept by separating between un-blinded team members (giving the actual treatment) and blinded team members, and by hiding the NO container and all study related equipment behind a curtain. All subjects will return for follow-up visits on day 14(+5), 21(+5) days and will be contacted on day 30 (+5) from day of admission to the department.