Wheezing Clinical Trial
Official title:
Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Year of Life by Using Bacterial Lysates.
The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first year of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.
This is a randomised placebo-controlled trial including 500 otherwise healthy moderate-late preterm infants. Participants will receive bacterial lysate (Broncho-Vaxom, 3,5mg) or placebo powder for ten days each month, from 6 weeks after birth until 12 moths of age. Clinical data will be continuously collected by e-Health and 3 (possibly digital) study visits; with optional biological sampling and lung function at baseline, 6 and 12 months. Main study parameters are doctor diagnosed lower RTI and wheezing episodes in the first year of life. Biological sampling will allow investigation of immune maturation, as well as microbiome development in the respiratory tract and gut. Also, biomarkers for risk-group selection and/or treatment success will be examined. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04669288 -
AZithromycin Therapy in Preschoolers With a Severe Wheezing Episode Diagnosed at the Emergency Department
|
Phase 3 | |
| Withdrawn |
NCT04584034 -
Bronchodilators for Wheeze in Young Children Presenting to Primary Care: a Randomised, Placebo-controlled, Multicentre, Parallel Group Trial
|
Phase 4 | |
| Terminated |
NCT02269761 -
Chest Ultrasound of ER Patients With Cough or SOB
|
||
| Enrolling by invitation |
NCT00775697 -
Montelukast in Children With Wheezing
|
Phase 4 | |
| Completed |
NCT00749528 -
Evaluation of Toxic Metals, Trace Elements and Total Antioxidant Activity in Children With Recurrent Wheezing
|
N/A | |
| Recruiting |
NCT00494624 -
Efficacy of Systemic Glucocorticoid in the Treatment of Wheezing in Children
|
Phase 4 | |
| Recruiting |
NCT04128592 -
Non-invasive Differential Diagnosis of Noisy Breathing Infants and Toddlers
|
N/A | |
| Recruiting |
NCT06093152 -
Video Assisted Study of Salbutamol Response in Viral Wheezing
|
||
| Completed |
NCT01452945 -
Bedside Lung Ultrasound in Young Children Presenting to the Emergency Department (ED) With Wheezing
|
N/A | |
| Withdrawn |
NCT00628303 -
A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants
|
Phase 3 | |
| Completed |
NCT01028560 -
Allergy Immunotherapy for the Reduction of Asthma
|
Phase 1/Phase 2 | |
| Completed |
NCT00626808 -
A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children
|
Phase 4 | |
| Completed |
NCT00507676 -
Lung Function and Structure in Healthy Infants and Infants With Recurrent Wheezing
|
N/A | |
| Completed |
NCT03600428 -
Safety of LAIV4 in Children With Asthma
|
Phase 4 | |
| Recruiting |
NCT06106646 -
Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function (VCSIP) Longer Term Follow Up
|
||
| Recruiting |
NCT05710081 -
Bacterial Lysate In Preventing Asthma
|
Phase 3 | |
| Completed |
NCT04011709 -
A Methodology Trial Using the VR647 Inhalation System in Pediatric Subjects Who Have Previously Received Inhaled Therapy
|
Early Phase 1 | |
| Active, not recruiting |
NCT03377192 -
Impedance Pneumography in Assessment of Asthma Control in Preschool Children
|
||
| Completed |
NCT01142505 -
Wheeze and Intermittent Treatment
|
Phase 3 | |
| Active, not recruiting |
NCT04942483 -
Using Specific Tests in Preschool Children With Wheeze to Help us Determine the Necessity of Inhaled Corticosteroid Therapy (Feasibility Study).
|