RecruitingPhase 3ACTRN12614000847617

Wheeze and Steroids in Preschoolers: Main study

In children aged between 24 and 59 months, presenting to emergency departments with acute preschool wheeze associated with a respiratory tract infection, is oral prednisolone 2mg/kg for 3 days equivalent to placebo in terms of respiratory distress measured at 24 hours by the Preschool Respiratory Assessment Measure (PRAM score).


Sponsor

Auckland District Health Board

Enrollment

400 participants

Start Date

Aug 18, 2014

Study Type

Interventional

Conditions

Summary

In school age children and adults we know prednisolone helps to reduce the length of wheezing. In children less than two years of age we know that prednisolone does not help children who wheeze. The few scientific studies that have been carried out in preschool children to assess the effect of prednisolone have had conflicting results. No one knows for sure if prednisolone helps preschool children with wheeze or not. Currently preschool children with wheeze are sometimes given prednisolone and sometimes they are not. We don’t know if giving prednisolone or not is the best treatment. The aim of this study is to determine if prednisolone helps to reduce the symptoms in preschool children with wheeze.


Eligibility

Sex: Both males and femalesMin Age: 24 MonthssMax Age: 59 Monthss

Plain Language Summary

Simplified for easier understanding

This study tests whether a steroid medicine called prednisolone helps reduce wheezing in children aged 2 to 5 years. We already know prednisolone works in older children and adults with asthma, but the evidence in young children is mixed, and this study aims to find a clear answer. You may be eligible if: - Your child is between 24 and 59 months old (2 to just under 5 years) - Your child is currently wheezing during an acute respiratory illness You may NOT be eligible if: - Your child's wheezing is very mild (PRAM score below 3) - Your child cannot be followed up within 18 to 38 hours - Your child has taken corticosteroids in the past 7 days - Your child has a chronic lung, heart, or neurological disease - Your child is allergic to prednisolone or has a contraindication to steroids - Your child's illness may be due to a swallowed foreign object - Your child is in a life-threatening state or has a history of life-threatening asthma - Your child has already participated in this study before Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

2mg/kg oral prednisilone, once daily for 3 days. First dose will be directly observed, adherence to doses 2 and 3 will be via parental report without additional monitoring.

2mg/kg oral prednisilone, once daily for 3 days. First dose will be directly observed, adherence to doses 2 and 3 will be via parental report without additional monitoring.


Locations(1)

New Zealand

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12614000847617