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Study on Oral Prednisolone and Sucrose for Treating Wheezing Caused by Rhinovirus in Children Under 2 Years Old

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 children under 2 years old who experience wheezing caused by a common cold virus known as the rhinovirus. Wheezing is a high-pitched whistling sound made while breathing, often associated with difficulty in breathing. The study aims to determine if a medication called prednisolone sodium phosphate, which is a type of steroid that helps reduce inflammation, can help these children. The treatment involves taking the medication orally, which means it is swallowed in the form of a liquid solution.

During the study, children will receive either the prednisolone sodium phosphate or a placebo, which is a substance with no active medication. The study will last for a short period, and the children will be monitored to see how quickly they recover from wheezing and if they need to stay in the hospital for a shorter time. The goal is to see if the medication helps them get better faster and reduces the need for additional medical care.

Parents and caregivers will be informed about the progress and any changes in the child's condition throughout the study. The study will also track if the children experience any recurrence of wheezing or other related symptoms over a period of time after the initial treatment. This research is important to find better ways to help young children who suffer from wheezing due to viral infections.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study entry
Upon arrival at the hospital, a child aged between 6 months and 2 years is diagnosed with acute wheezing by an emergency department physician.
A nasal swab test confirms the presence of rhinovirus or another picornavirus.
The child must have arrived at the hospital within the past 6 hours and received salbutamol treatment at the emergency department.
Step 2
Medication administration
The child receives oral prednisolone sodium phosphate to address the wheezing symptoms.
The dosage and frequency of administration are determined by the medical team based on the child's specific needs.
Step 3
Monitoring and assessment
The primary endpoint is the time difference in minutes between study entry and when the child is deemed fit for discharge.
Secondary endpoints include the total length of hospital stay, any need for intensive care, and the duration of supplemental oxygen use.
The child's PEWS score is monitored, which assesses various health indicators such as respiratory rate and heart rate.
Step 4
Follow-up period
The child is observed for any recurrence of wheezing within 56 days following study enrollment.
Additional follow-ups include monitoring for cough, respiratory distress, and any hospital readmissions or emergency department visits.
Long-term follow-up includes tracking the recurrence of wheezing and any need for asthma medication over a period of up to two years.

Who can join the trial?

5 criteria

Children must be between the ages of 6 months and 2 years.
The child must have **acute wheezing**, which means sudden and severe breathing difficulty, diagnosed by a doctor in the emergency department.
A test must show a **positive result for rhinovirus or other picornavirus** in a nasal swab. This means the virus causing the wheezing is identified from a sample taken from the nose.
The child must have arrived at the hospital within the past 6 hours.
The child must have received **salbutamol treatment** at the emergency department. Salbutamol is a medication used to help open the airways and make breathing easier.

Who cannot join the trial?

7 criteria

Children who are not between 6 months and 2 years old.
Children who do not have wheezing caused by a virus called rhinovirus or other similar viruses.
Children who have not been tested for these viruses at the emergency department.
Children who have other medical conditions that might interfere with the study.
Children who are taking medications that could affect the study results.
Children who have allergies to the study medication, which is called oral prednisolone. This is a type of medicine that helps reduce inflammation and swelling.
Children whose parents or guardians do not agree to participate in the study.

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Verified sites

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Oulu University Hospital
Oulu, Finland

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Investigated drugs

Prednisolone is a medication used in this trial to help children who are experiencing acute wheezing due to a rhinovirus or other picornavirus infection. The study aims to see if giving oral prednisolone to children aged 6 months to 2 years can improve their symptoms. Prednisolone is a type of steroid that can reduce inflammation and help with breathing difficulties.

What is already known about the treatment

Prednisolone – Prednisolone is administered orally, typically in the form of tablets or liquid, and is used to treat various inflammatory and allergic conditions. In the context of current medical research, it is being studied for its effectiveness in treating acute wheezing in young children caused by rhinovirus. The main therapeutic indication for this study is rhinovirus-induced wheezing in children under 2 years of age. Prednisolone works by suppressing the immune system's response to inflammation, reducing swelling and irritation in the airways. It is classified as a corticosteroid, which is a type of medication that mimics the effects of hormones produced by the adrenal glands.

Investigated diseases

Rhinovirus-induced Wheezing – This condition occurs when the rhinovirus, a common cause of the cold, triggers wheezing in the respiratory system. It is particularly prevalent in young children and can lead to episodes of difficulty breathing. The wheezing is caused by the narrowing of airways due to inflammation and increased mucus production. Symptoms may include a whistling sound when breathing, shortness of breath, and coughing. The condition can vary in severity, with some children experiencing mild symptoms and others having more significant respiratory distress. It often requires monitoring to manage symptoms and prevent complications.