Ongoing Clinical Trials for Bronchiolitis
Currently, there are 3 ongoing clinical trials focused on bronchiolitis and related respiratory conditions in young children. These studies are exploring different approaches to prevent and treat breathing difficulties in infants and children, including corticosteroid treatments, preventive vaccines and antibodies against respiratory syncytial virus (RSV), and optimal oxygen therapy strategies during hospital care.
Clinical trial locations
- Finland
- France
- Netherlands
- Norway
- Sweden
Study on Betamethasone Sodium Phosphate to Prevent Asthma in Children with First-time Rhinovirus-induced Wheezing
This trial is testing whether systemic corticosteroids, specifically dexamethasone, can prevent future episodes of wheezing and the development of asthma in young children who have experienced their first severe wheezing episode caused by rhinovirus infection.
Main inclusion criteria:
- Children between 3 and 24 months of age
- Experiencing their first episode of severe wheezing that started less than 7 days ago
- Referred to hospital with symptoms including fever, low oxygen levels, difficulty breathing, or specific breathing sounds
- Confirmed rhinovirus infection by PCR test from a nose or throat sample
- Signed parental consent to participate
Main exclusion criteria:
- Previous episodes of wheezing or bronchiolitis
- No rhinovirus infection present
- Not experiencing their first severe wheezing episode
- Outside the specified age range
- Unable to take systemic corticosteroids
Trial focus: The study aims to determine whether early treatment with corticosteroids during the first severe rhinovirus wheezing episode can reduce the risk of recurrent wheezing and prevent asthma development. Children will be monitored for 24 months, with researchers tracking new wheezing episodes, asthma criteria, symptom severity and duration, lung reactivity, quality of life, and growth measurements.
Investigational treatment: The trial uses systemic corticosteroids, which are anti-inflammatory medications that calm down the immune system and reduce swelling in the airways. These medications work by decreasing inflammation and mucus production, making breathing easier. Children will receive either dexamethasone or a placebo tablet according to the study protocol.
Study of nirsevimab and RSV vaccine (Abrysvo) for prevention of respiratory syncytial virus infection in infants during their first year of life
This trial examines two different approaches to preventing respiratory syncytial virus infections and related breathing problems in infants during their first year of life. The study compares giving both an RSV vaccine to pregnant mothers and nirsevimab to their babies versus giving only nirsevimab to infants during RSV season.
Main inclusion criteria:
- Pregnant women between 32 and 36 weeks plus 6 days of pregnancy
- Over 18 years of age
- Social security coverage or equivalent insurance
- Able to read and complete questionnaires in French or English
- Willing to follow all study requirements and provide written consent
- Agreement to receive vaccination during pregnancy (if assigned to that group)
- Agreement for their baby to receive nirsevimab
- Delivery of a live baby
Main exclusion criteria:
- Infants with known allergies to RSV vaccine components
- Babies with severe medical conditions or compromised immune systems
- Infants who received other RSV prevention treatments
- Babies born before 32 weeks of pregnancy
- Infants with active respiratory infections at enrollment
- Babies with genetic disorders or birth defects affecting the respiratory system
- Infants previously hospitalized for respiratory problems
- Babies participating in other clinical trials
Trial focus: The study monitors infants throughout their first year of life to assess which prevention strategy better protects against RSV-related breathing problems. Participants are divided into two groups: one where mothers receive the Abrysvo vaccine during pregnancy and babies receive Beyfortus at 4 months, and another where babies receive only Beyfortus during RSV season. Researchers track respiratory infections, hospital visits, and the need for medical care related to breathing difficulties.
Investigational treatments: The trial uses two products: nirsevimab (Beyfortus), a long-acting antibody given to infants as a single muscle injection to help the immune system fight RSV for approximately five months, and Abrysvo, a vaccine given to pregnant women between 32 and 36 weeks of pregnancy that helps create antibodies passed to the baby before birth, providing protection during the infant’s vulnerable early months.
Study on Oxygen Levels for Children and Adolescents with Respiratory Distress: Focusing on Bronchiolitis, Viral Wheeze, and Lower Respiratory Tract Infection
This trial investigates whether using specific oxygen level targets can safely reduce the length of hospital stay for children with respiratory distress. The study compares two different oxygen saturation targets (88% versus 92%) to determine which is more effective in helping children recover faster.
Main inclusion criteria:
- Children aged 6 weeks to 12 years
- Hospitalized with lower respiratory distress due to bronchiolitis, viral wheeze, or lower respiratory tract infection
- Requiring supplemental oxygen (blood oxygen levels below 92% or as determined by the treating doctor)
Main exclusion criteria:
- Children not experiencing the specified respiratory conditions (bronchiolitis, viral wheeze, or lower respiratory tract infection)
- Children not experiencing respiratory distress
- Children outside the specified age range
- Children not part of the vulnerable population selected for the study
Trial focus: The study monitors various aspects of recovery, including time to meet discharge criteria, length of hospital stay, admissions to pediatric intensive care units, duration of oxygen therapy, and symptom duration. Researchers also evaluate quality of life, parental anxiety, and the economic impact of treatment. The goal is to find the safest and most effective way to manage oxygen levels in hospitalized children with breathing difficulties.
Investigational treatment: The trial uses oxygen therapy delivered through masks or nasal tubes. Oxygen is provided at different target saturation levels to determine which approach best supports recovery while maintaining safety. The treatment works by increasing the amount of oxygen available for the lungs to absorb and transport throughout the body to tissues and organs that need it.
Summary
These three clinical trials represent different approaches to managing bronchiolitis and related respiratory conditions in children. The research spans multiple European countries, with trials taking place in Finland, France, the Netherlands, Norway, and Sweden.
The trials focus on three distinct strategies: preventing asthma development after viral wheezing episodes using corticosteroids, preventing RSV infections through maternal vaccination and infant antibody treatments, and optimizing oxygen therapy during hospital care. Each study targets different age groups, from newborns to children up to 12 years old, reflecting the various stages at which respiratory conditions can affect young patients.
A notable aspect is the emphasis on prevention strategies, with two of the three trials focusing on preventing future respiratory problems rather than just treating acute episodes. The RSV prevention trial in France is particularly innovative in comparing combined maternal-infant protection versus infant-only approaches. Meanwhile, the oxygen therapy study in the Netherlands addresses a practical question about daily hospital care that could immediately impact treatment protocols if successful.
These studies collectively aim to improve outcomes for children with respiratory difficulties, whether through prevention, early intervention, or optimized supportive care during hospitalization.
