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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Ajmablomxh Pbbwfvhr Hfadxsos Dx Mstqvhfjv Marseille France
Crvnxu Hgwzgmhdkgl Rqbvrify Uejlfudcacnnu Db Toffx Tours France
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Hbkinqkq Ukqwdfmagmebcl Sddhclglqi &valrik Hvohynp ds Hzptbixioyi STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
02.09.2024

Trial locations

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.

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.

Trial ID:
2023-504829-39-00
Protocol code:
APHP220674
Trial Phase:
Therapeutic confirmatory (Phase III)

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