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Study on Dexamethasone Phosphate for Reducing Breathing Problems in Children with Upper Airway Obstruction in Intensive Care

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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 medication called Dexamethasone Phosphate in children who are experiencing respiratory distress due to an obstruction in the upper airway. Respiratory distress is a condition where breathing becomes difficult, often requiring medical intervention. The trial aims to evaluate how effective Dexamethasone Phosphate is in reducing the occurrence of breathing problems after the removal of a breathing tube, compared to a placebo, which is a substance with no active medication.

Participants in this study will receive either Dexamethasone Phosphate, which is given as an injection, or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations. The main goal is to see if Dexamethasone Phosphate can help reduce the incidence of breathing difficulties within 48 hours after the breathing tube is removed.

The study will also look at other factors, such as the need for reintubation, which is the process of placing the breathing tube back if necessary, and the number of days children spend in the hospital. Additionally, the study will monitor any side effects that may occur from the medication. The trial is expected to run until 2027, with recruitment starting in 2024. This research is important for understanding how to better manage breathing issues in children who have been in intensive care.

The research process

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

Step 1
Joining the study
Upon joining the study, consent from both parents or legal guardians is required. This ensures understanding and agreement to participate in the trial.
Step 2
Eligibility confirmation
Eligibility is confirmed based on specific criteria: the child must be aged from 2 days post-term to 6 years, intubated with or without a cuff, and under mechanical ventilation for at least 36 hours. The child must also meet certain extubation criteria, such as planned extubation by the medical team and specific oxygen and pressure levels.
Step 3
Randomization
The child will be randomly assigned to receive either the **dexamethasone phosphate** or a **placebo**. This process is double-blind, meaning neither the medical team nor the parents will know which treatment is given.
Step 4
Medication administration
If assigned to the **dexamethasone phosphate** group, the child will receive the medication through an intravenous route. The dosage and frequency will be determined by the medical team based on the child's specific needs.
Step 5
Monitoring and evaluation
The child will be closely monitored for 48 hours post-extubation to evaluate the effectiveness of the treatment in reducing respiratory distress. The medical team will observe for any side effects and the need for reintubation.
Step 6
Follow-up
The child's progress will be tracked, including the number of days in the pediatric intensive care unit and days free of ventilatory assistance. This information helps assess the overall impact of the treatment.

Who can join the trial?

12 criteria

Children with **breathing problems** due to a blocked upper airway.
Must have a **breathing tube** inserted, which may or may not have a cuff (a small balloon that helps keep the tube in place).
Must be part of a **social security system**.
Parents or legal guardians must give **informed consent**, meaning they agree to the child's participation after understanding the study.
Children must be **between 2 days old (after full-term birth) and 6 years old**.
Must have been on a **ventilator** (a machine that helps with breathing) for at least **36 hours**.
Must meet the following **extubation criteria** (conditions for removing the breathing tube):
The medical team has planned to remove the tube.
The **oxygen level** they are breathing in is **45% or less**.
Their **oxygen saturation** (amount of oxygen in the blood) is **95% or higher**, or appropriate for their condition.
The **positive expiratory pressure** (pressure in the lungs when breathing out) is **8 cmH2O or less**.
The **peak inspiratory pressure** (pressure in the lungs when breathing in) is **22 cmH2O or less**, or they have a **cough**.

Who cannot join the trial?

4 criteria

Children who are not experiencing respiratory distress due to an upper airway blockage cannot participate. Respiratory distress means having trouble breathing.
Children who are not hospitalized in the specific unit for this condition cannot participate.
Children who are not within the specified age range cannot participate.
Children who are part of a vulnerable population that is not selected for this study cannot participate.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France

Trial locations

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Investigated drugs

DXM-IV is a medication used in this clinical trial to help reduce breathing problems in children who are in the intensive care unit. It is given to patients to see if it can lower the chances of having difficulties with breathing after they are taken off a breathing machine. The goal is to make sure that children can breathe more easily on their own after being on the machine. This medication is being compared to a placebo to see how effective it is in helping with these breathing issues.

Dexamethasone Phosphate

What is already known about the treatment

DXM-IV – DXM-IV is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials to assess its effectiveness in children with breathing difficulties due to upper airway obstruction, particularly in a pediatric intensive care setting. The main therapeutic use of DXM-IV is to help reduce the incidence of breathing problems after removing a breathing tube in children. At the molecular level, DXM-IV works by reducing inflammation and swelling in the airways, which helps improve breathing. It belongs to a class of drugs known as corticosteroids, which are often used to treat inflammation in various medical conditions.

Investigated diseases

Respiratory Distress Due to Upper Airway Obstruction in Child – This condition occurs when a blockage in the upper airway leads to difficulty in breathing in children. The obstruction can be caused by various factors such as inflammation, foreign objects, or anatomical abnormalities. As the condition progresses, the child may exhibit signs of labored breathing, stridor (a high-pitched wheezing sound), and increased effort to breathe. The severity of symptoms can vary, with some children experiencing mild discomfort while others may have significant breathing difficulties. In severe cases, the child may require medical intervention to relieve the obstruction and restore normal breathing. Monitoring and supportive care are essential to manage the condition effectively.