Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Oxygen Levels for Children and Adolescents with Respiratory Distress: Focusing on Bronchiolitis, Viral Wheeze, and Lower Respiratory Tract Infection

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on children and adolescents who are experiencing respiratory distress, which can be caused by conditions such as bronchiolitis, viral wheeze, or a lower respiratory tract infection. The study is investigating the use of a treatment involving a medicinal gas called Conoxia Liquid, which is 100% oxygen. The purpose of the study is to determine if using a specific oxygen level target can safely reduce the length of hospital stay for these young patients.

Participants in the study will be children aged 6 weeks to 12 years who are hospitalized and require additional oxygen. The study will compare two different oxygen level targets to see which one is more effective in helping children recover faster. The trial will monitor various aspects of the children's recovery, including the time it takes for them to meet all discharge criteria, the length of their hospital stay, and their overall health after leaving the hospital.

Throughout the study, researchers will also look at other factors such as the number of admissions to the pediatric intensive care unit (PICU), the time spent on oxygen therapy, and the duration of symptoms. Additionally, the study will consider the children's quality of life, parental anxiety, and the economic impact of the treatment. The goal is to find a safe and effective way to manage oxygen levels in children with respiratory distress, ultimately improving their recovery and overall health.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the eligibility criteria are confirmed. Participants are children aged 6 weeks to 12 years, hospitalized with lower respiratory distress due to conditions like bronchiolitis, viral wheeze, or lower respiratory tract infection, and requiring supplemental oxygen.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to determine the current health status and specific needs. This includes measuring the blood oxygen level, known as SpO2. If the SpO2 is below 92% or as indicated by the treating physician, supplemental oxygen is required.

  3. Step 3

    Oxygen therapy

    Participants receive oxygen therapy using Conoxia Liquid, a medicinal gas. The therapy is administered through respiratory use, meaning it is inhaled. The goal is to maintain safe oxygen saturation levels, either at 88% or 92%, depending on the group assignment.

  4. Step 4

    Monitoring and adjustments

    Throughout the hospital stay, health status is closely monitored. Adjustments to oxygen therapy are made as needed to ensure safety and effectiveness. The primary focus is on reducing the length of hospital stay while maintaining safe oxygen levels.

  5. Step 5

    Discharge criteria

    Discharge from the hospital occurs once all criteria are met. This includes stable oxygen levels and overall improvement in health. The time from admission to meeting these criteria is a key measure in the study.

  6. Step 6

    Follow-up

    After discharge, follow-up assessments are conducted to evaluate recovery. This includes monitoring the duration of symptoms, time to return to normal activities like school or daycare, and any unscheduled healthcare visits. Patient quality of life and parental anxiety are also assessed.

Who can join the trial?

3 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 (oxygen levels in the blood, known as SpO2, are less than 92% or as determined necessary by the doctor)

Who cannot join the trial?

6 criteria

  • Children and adolescents who do not have **bronchiolitis**, which is a common lung infection in young children.
  • Children and adolescents who do not have **viral wheeze** or **bronchial hyperreactivity**, which means their airways are more sensitive and can narrow easily.
  • Children and adolescents who do not have a **lower respiratory tract infection**, which affects the lungs and lower airways.
  • Children and adolescents who are not experiencing **respiratory distress**, which means they are having trouble breathing.
  • Children and adolescents who do not meet the age range specified for the study.
  • Children and adolescents who are not part of the vulnerable population selected for the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

The provided data does not include specific medications or therapies involved in the clinical trial. The trial focuses on oxygen saturation targets for children and adolescents with respiratory distress. Therefore, the main therapy involved in this trial is the administration of oxygen. Oxygen Therapy: This therapy involves providing extra oxygen to children and adolescents who have difficulty breathing due to respiratory distress. The trial is investigating different levels of oxygen saturation, which is a measure of how much oxygen the blood is carrying. The goal is to find out if using a lower oxygen saturation target (88%) is as safe and effective as a higher target (92%) in reducing the length of hospital stay. Oxygen is delivered through devices like masks or tubes placed in the nose, helping patients breathe easier and ensuring their bodies get enough oxygen.

What is already known about the treatment

Oxygen Therapy – Oxygen therapy is administered through a mask or nasal cannula to help children and adolescents with breathing difficulties, such as those caused by bronchiolitis, viral wheeze, or lower respiratory tract infections. In medical literature, oxygen therapy is a well-established treatment for respiratory distress, aiming to maintain adequate oxygen levels in the blood. The main therapeutic indication is to alleviate symptoms of respiratory distress by ensuring sufficient oxygen supply to the body. At the molecular level, oxygen therapy works by increasing the amount of oxygen available for uptake by the lungs, which is then transported by the blood to tissues and organs. It is classified as a respiratory support therapy.

Investigated diseases

  • Bronchiolitis

    Bronchiolitis is a common lung infection in young children and infants, characterized by inflammation of the small airways called bronchioles. It typically begins with symptoms similar to a common cold, such as a runny nose, cough, and mild fever. As the disease progresses, it can lead to wheezing, difficulty breathing, and increased respiratory rate. The inflammation and mucus buildup in the bronchioles can cause obstruction, making it hard for the child to breathe. The condition is usually caused by viral infections, with the respiratory syncytial virus (RSV) being the most common culprit. Symptoms often peak around the third to fifth day and gradually improve over time.

  • Viral wheeze / bronchial hyperreactivity

    Viral wheeze, also known as bronchial hyperreactivity, occurs when the airways become overly responsive to viral infections, leading to wheezing and difficulty breathing. It is often triggered by common respiratory viruses, such as those causing colds. The condition is characterized by a high-pitched whistling sound during breathing, especially when exhaling. As the airways become inflamed and constricted, the child may experience shortness of breath and coughing. The wheezing episodes can vary in frequency and severity, often worsening with viral infections. Over time, the airways may return to normal responsiveness once the infection resolves.

  • Lower respiratory tract infection

    Lower respiratory tract infection refers to infections that affect the airways below the voice box, including the trachea, bronchi, and lungs. Common symptoms include cough, chest discomfort, and difficulty breathing. As the infection progresses, it can lead to increased mucus production and inflammation, causing further breathing difficulties. These infections are often caused by viruses or bacteria and can vary in severity. The condition can affect individuals of all ages but is particularly concerning in young children and the elderly. Recovery time can vary depending on the cause and severity of the infection.

Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2023-504817-56-00Protocol code2022.0100Estimated enrolment560 patientsSponsorSpaarne Gasthuis

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.