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Bronchiolitis clinical trials

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NCT ID: NCT06376487 Recruiting - Bronchiolitis Clinical Trials

Pulmonary Aeration and Muscle Thickening Fraction: Association of Electrical Impedance Tomography and Ultrasound

Start date: May 1, 2024
Phase: N/A
Study type: Interventional

The goal of this prospective clinical study is to evaluate the effect of different High Flow Nasal Cannula (HFNC) flow rates on diaphragm, rectoabdominal, and oblique thickening fraction, and to determine whether this effect depends on the action of HFNC flow rates on Functional Residual Capacity (FRC) in Infants under 2 years of age with a diagnosis of bronchiolitis and indication for use of HFNC. The main question[s] it aims to answer are: - If the thickening fraction of the abdominal muscle and diaphragm will change at the different flow rates evaluated - If the end-expiration lung impedance (EELZ) will change at the different flow rates evaluated The belt will be installed around the chest before the start of the change in flow rates and monitoring with Electrical Impedance Tomography (EIT) will be initiated. Patients will be positioned in dorsal decubitus elevated 10 to 20 degrees and monitoring will be performed continuously during all flow rate variations and also during the ultrasound performance. Four different randomized flow rates will be used for evaluation: 2.0 liter.Kg-1.min-1, 1.5 liter.Kg-1.min-1, 1.0 liter.Kg-1.min-1, 0.5 liter.Kg-1.min-1. At the end of the randomized order evaluation the infant will remain in the flow of 0.5 liter.Kg-1.min-1 for 5 minutes and then return to the flow of 2.0 liter.Kg-1.min-1. The EIT parameters, ultrasound assessment, and clinical variables will be collected at the end of the 5-minute stay in each lane. The randomization of the order of application of the phases will be carried out in blocks, so that the homogeneity of the sequences is maintained even if the collection is interrupted before reaching the total number of individuals. The blocks will be of size two and four and the test and production lists will be generated with the help of the R packages.

NCT ID: NCT06321133 Recruiting - Acute Bronchiolitis Clinical Trials

High Flow Nasal Cannula Weaning in Acute Bronchiolitis

Start date: February 13, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. This study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. The aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy.

NCT ID: NCT06304727 Recruiting - Bronchiolitis Clinical Trials

Evaluation of Short Enteral Nutrition in the Emergency Room for Bronchiolitis With Main Nutritional Impairment

1TreSBCD
Start date: November 21, 2022
Phase:
Study type: Observational

The winter epidemic of bronchiolitis in infants poses insurmountable difficulties for the hospital system for the 2022-2023 season globally. These difficulties are linked to the combination of an unusual epidemic intensity and the loss of medical and paramedical caregivers in the hospital leading to the closure of beds since the Covid-19 pandemic. Bronchiolitis in youngest and most vulnerable infants can lead to severe clinical pictures requiring hospitalization. Among them, some infants present exclusively with inability to eat and only require continuous enteral nutrition during their hospitalization. A service protocol has been put in place in the pediatric emergency room of the Hôpital Femme Mère Enfant for the 2022-2023 season to carry out short enteral nutrition and monitoring before returning home. This outpatient care would aim to reduce the effect of hospital saturation during the winter epidemic of bronchiolitis, increase the comfort and satisfaction of families by allowing less disruption of family life and prevent nosocomial infections. A retrospective evaluation of the feasibility and effectiveness of this protocol is necessary to rely on this first experience of outpatient management.

NCT ID: NCT06267118 Recruiting - Clinical trials for Acute Bronchiolitis Due to Respiratory Syncytial Virus

Comparative Efficacy of Hypertonic Saline vs Adrenaline Nebulization in Acute Bronchiolitis

children
Start date: November 1, 2023
Phase: Phase 3
Study type: Interventional

The goal of this clinical trial is to compare the efficacy of hypertonic saline nebulization with adrenaline nebulization in the treatment of acute bronchiolitis in children. Main aim is to evaluate the following in both group of patients 1. Improvement in Wood-Downes clinical score (WDF score) in bronchiolitis 2. Length of Hospitalization

NCT ID: NCT06204367 Enrolling by invitation - Bronchiolitis Clinical Trials

Evaluation of Lung Ultrasonography Findings in Newborns With Respiratory Syncytial Virus Bronchiolitis

Start date: December 1, 2023
Phase:
Study type: Observational [Patient Registry]

Respiratory Syncytial Virus (RSV) is a seasonal, highly contagious pathogen belonging to the Pneumoviridae (genus orthopneumovirus), a family of negative-strand RNA viruses. Lung ultrasonography; Today, it has become frequently used in neonatal intensive care units because it is a diagnostic, useful, harmless, radiation-free, bedside, reproducible and practical method. The primary purpose of the study is to record lung ultrasound findings and score and thus to compare the agreement between lung ultrasonography and clinical score in the diagnosis and follow-up of newborn babies who are followed up in the neonatal intensive care unit due to bronchiolitis caused by RSV and other viral factors, which are frequently encountered.

NCT ID: NCT06185647 Recruiting - Bronchiolitis Clinical Trials

Evaluation in Practice of the Impact of NIrsevimab on EmeRgency Use for BRONCHIOlitis

EPINIR-BRON
Start date: October 14, 2023
Phase:
Study type: Observational

In July 2023, the Food and Drug Administration approved nirsevimab (Beyfortus®), a long-acting monoclonal antibody, for passive immunization to prevent RSV-associated lower respiratory tract infection (Bronchiolitis) among infants and young children. In Europe, The European Medicines Agency approved the use of BEYFORTUS in October 2022. In France, The Haute Autorité de Santé (HAS) approved the use of BEYFORTUS in July 2023 starting in September 2023. Beyfortus is administered as a single intramuscular injection prior to or during RSV season. This single dose may provide protection during the whole RSV season. The safety and efficacy of Beyfortus® were supported by three clinical trials (1-3). The key measure of efficacy was the incidence of medically attended RSV lower respiratory tract infection (MA RSV LRTI ) evaluated during the 150 days after Beyfortus® administration. Beyfortus® reduced the risk of MA RSV LRTI by approximately 70% to 75% relative to placebo. The objective of this observational study is to assess in the real-world the effectiveness of nirsevimab on the Emergency Department use for bronchiolitis as well on the effectiveness of nirsevimab to reduce hospitalization and healthcare usage in France where a national campaign to administer nirsevimab to young infants stated on September 14th, 2023. Type of study Retrospective observational study of medical records which include systematic and prospective data on nirsevimab immunization status of patients visiting the Emergency Department. Methodology This retrospective observational study will include two data set analysis. On one part, data from all infants presenting to the emergency department and diagnosed as having bronchiolitis will be retrieved from medical and nursing records and those who had been given nirsevimab will be compared with those who did not receive this medication prior to the ED visit. On the other part, since the investigators have included nirsevimab administration in their systematic data collection on immunization of all infants visiting our ED, the investigators will use the nirsevimab immunization status of infants diagnosed as having bronchiolitis with those do not having bronchiolitis in order to assess the effectiveness (real-world effect) of nirsevimab on the ED use and hospitalization.

NCT ID: NCT06177197 Not yet recruiting - Bronchiolitis Acute Clinical Trials

Bronchiolitis Clearance Airways With Seaserum

B-CLASS
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06161285 Not yet recruiting - Bronchiolitis Clinical Trials

Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants

BRONCHOBIOTE
Start date: April 2024
Phase: N/A
Study type: Interventional

Acute bronchiolitis is a common disease in children under the age of two, caused mainly by the respiratory syncytial virus (RSV). Furthermore, given the same medical history, it is still very difficult to predict the course and severity of the infection at the onset of symptoms, Some studies have highlighted the importance of the microbiota (intestinal, oral or nasopharyngeal) and of the immune response to RSV in children, We will include 80 children under 2 years old with hospitalized bronchiolitis and non-hospitalized bronchiolitis. Oral, nasal and stool samples will be taken to study the various microbiota in search of dysbiosis. A capillary blood sample will be taken for immune studies.

NCT ID: NCT06156436 Completed - Pneumonia Clinical Trials

A Study Evaluating the Use of ResAppDx v2.0 as an Aid to Diagnose Respiratory Disease in Paediatric Patients in an Emergency Department

Start date: January 1, 2024
Phase:
Study type: Observational

Aim of study is to demonstrate that the ResAppDx v2.0 algorithms provide an accurate diagnosis of paediatric respiratory disease in the study's clinical setting compared to a Clinical Adjudication Committee's (CAC) diagnosis; and to establish a baseline for the resource use and cost of current care pathways for paediatric respiratory disease diagnosis in an emergency department. Eligible subjects/parents will be assented/consented, enrolled and their subject reported signs/symptoms of respiratory disease will be recorded in the study electronic case report form (eCRF).The enrolled subject's cough sounds will be captured (5 cough sounds are required) using the ResAppDx v2.0 Investigational Device (ID) software installed on a study smartphone; cough sounds may be voluntary and/or involuntary/spontaneous. As this is an observational study the treating team will be blinded to the ResAppDx v2.0diagnoses. Additional medical information will be collected from the treating team, from the subject/parent and from the subject's medical record. No follow-up/subsequent visits with the subject will be required by the study. As an efficacy comparator, a CAC will determine the final clinical diagnosis for each enrolled subject using the disease case definitions, eCRF data, the subject's medical record and cough sound recordings.Information on time and scope of tests and consults ordered by the treating team will be recorded to set a baseline for resource use and cost and time of current standard of care treatment/assessment procedures. This data will allow future health economics analyses to be performed.The blinded ResAppDx v2.0diagnoses will be unblinded after database lock and sensitivity and specificity will be calculated for the ResAppDx v2.0diagnoses compared to agreement with the CAC's final clinical diagnoses for this cohort.

NCT ID: NCT06140901 Recruiting - Clinical trials for Bronchiolitis Obliterans

Bronchial Epithelium of Children With Post-infectious Bronchiolitis Obliterans

e-PIBO
Start date: December 4, 2023
Phase: N/A
Study type: Interventional

Bronchiolitis obliterans (BO) is an irreversible chronic obstructive pulmonary pathology leading to obstruction and/or obliteration of the small airways. In children, the most common form of BO occurs following a serious lower respiratory tract infection. This is a rare complication; the incidence is unknown. The diagnosis, often late, is made on clinical, spirometric and radiological arguments. The pathophysiology would be linked to damage to the airway epithelium. PIBO is most commonly associated with adenovirus (ADV) infection (serotypes 3, 7, 11 and 21) but also other viruses such as rhinovirus (RV). The treatment of PIBO is not clearly established, it remains empirical. The research hypothesis is that the morphology of the nasal epithelium of children with ADV or RV infection is different for those progressing to PIBO. The main objective of the proposed observational study is to characterize damage to the respiratory epithelium in these children. This is a single-center prospective longitudinal study (AP-HM), in children aged 1 month to 6 years, comparing children hospitalized for lower respiratory infection by ADV or RV progressing or not to PIBO. All children included will have a nasal swab and brushing on D0. Children developing PIBO will have nasal brushing with bronchial endoscopy with bronchial biopsies and bronchoalveolar washing at the time of PIBO diagnosis and again at M6 in case of partial response to treatment. This is therefore a pilot study aimed at defining damage to the respiratory epithelium in children with PIBO following an ADV or RV infection and the role of respiratory epithelial cells in PIBO.