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Study on How Nitrous Oxide and Oxygen Affect Lung Health in Children with Respiratory Disorders

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the effects of a treatment called KALINOX 50%/50%, which is a medicinal gas made up of nitrous oxide and oxygen. The study is specifically looking at children who have respiratory disorders, such as severe asthma or suspected lung infections, and need to have samples taken from their airways. The main goal is to see if using this gas changes the types of bacteria found in the lungs of these children.

During the study, children will inhale the gas, and samples will be collected from their airways to analyze the bacteria present. The study will also look at how well children tolerate the gas and how it affects the quality of the samples collected. Researchers will use different methods to assess the variety of bacteria in the lungs and will also monitor any side effects that might occur.

The trial aims to provide a better understanding of how nitrous oxide affects lung bacteria in children with respiratory issues. This information could help improve treatments for children with conditions like severe asthma or lung infections. The study is expected to continue until December 2026.

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

    Eligibility is determined based on age (3 months to 8 years) and the need for respiratory sampling due to suspected lower respiratory infection or severe asthma.

    Consent is required from at least one legal representative of the child.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the child's inability to effectively expel mucus from the lungs.

    The child must be affiliated with the social security system.

  3. Step 3

    Administration of medicinal gas

    The child inhales a medicinal gas called KALINOX 50%/50%, which is a mixture of nitrous oxide and oxygen.

    This gas is administered through inhalation to assist in collecting respiratory samples.

  4. Step 4

    Collection of respiratory samples

    Respiratory samples are collected to analyze the lung microbiota.

    The samples are assessed for bacterial diversity and quality.

  5. Step 5

    Monitoring and evaluation

    The child's response to the gas is monitored using age-appropriate anxiety scores and feedback from parents and practitioners.

    Any adverse events are recorded.

  6. Step 6

    Analysis of results

    The primary focus is on the diversity of bacteria in the lungs, assessed through various indices.

    Secondary analyses include the quality of samples and the identification of bacterial types using advanced techniques.

Who can join the trial?

5 criteria

  • Children aged 3 months to 8 years can participate.
  • Children who need a specific test called **ECBC sampling**. This is done when they have trouble breathing and might have a lung infection, like a bad cold or asthma attack, or if they have severe asthma.
  • At least one of the child's legal guardians must give their **free, informed, and written consent**. This means they agree to let their child participate after understanding what the study involves.
  • The child must be part of the **social security system**. This is a program that helps cover medical costs.
  • The child must not be able to **expectorate** effectively. This means they cannot cough up mucus or phlegm from their lungs.

Who cannot join the trial?

5 criteria

  • Children who are not suspected of having a **lower respiratory tract infection**. This means the child must have signs that suggest an infection in the lungs or airways.
  • Children who cannot provide a sample of **sputum**. Sputum is a mixture of saliva and mucus that is coughed up from the respiratory tract.
  • Children who have a medical condition that makes it unsafe to participate in the study.
  • Children who are not within the age range specified for the study.
  • Children who are part of a vulnerable population that the study cannot safely include.
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Investigated drugs

Nitrous Oxide: This is a gas used for its calming and pain-relieving effects. In this trial, it is being studied to see if it changes the types of bacteria in the lungs of children who need samples taken from their airways.

What is already known about the treatment

Nitrous Oxide – Nitrous Oxide is administered as an inhaled gas, typically through a mask, and is commonly used for its anesthetic and analgesic properties. In medical literature, it is well-documented for its use in various medical procedures, particularly in pediatric settings. The main therapeutic indication in this context is to assist in respiratory sampling for children with suspected lower respiratory tract infections. At the molecular level, Nitrous Oxide acts by modulating the activity of neurotransmitters in the brain, leading to pain relief and sedation. It is classified pharmacologically as an inhalation anesthetic.

Investigated diseases

Pediatric Respiratory Disorder – This condition involves issues with the respiratory system in children, affecting their ability to breathe properly. It can include a range of problems such as infections, asthma, or other lung-related issues. Symptoms may include coughing, wheezing, shortness of breath, and difficulty breathing. The progression of the disorder can vary depending on the underlying cause and the child's overall health. Infections may lead to increased mucus production and inflammation in the airways. Over time, if not managed, it can impact a child's daily activities and overall well-being.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2024-518197-14-00Protocol code29BRC23.0238Estimated enrolment40 patientsSponsorCentre Hospitalier Regional Et Universitaire De Brest

sourced from the EU Clinical Trials Register and site verification

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