TerminatedPhase 4ACTRN12608000608369

A study of aminophylline for infants less than 12 months of age with bronchiolitis, requiring admission to intensive care

Randomised, double-blind, placebo-controlled trial of aminophylline in infants less than 12 months of age with bronchiolitis who require intensive care, to assess if aminophylline is superior to placebo in reducing the duration of ventilatory support.


Sponsor

Prof Frank Shann

Enrollment

274 participants

Start Date

Oct 5, 2002

Study Type

Interventional

Conditions

Summary

Bronchiolitis is a common, acute, viral infection of the lower respiratory tract. It is mostly seen in children less than 1 year of age, but does affect children up to 2 years of age. Each year, several children with severe bronchiolitis need admission to the intensive care unit. These children experience significant breathing difficulty and around 50% are ill enough to need help with breathing through a breathing machine called a mechanical ventilator. The normal treatment for these children is to support their breathing, and to give them adequate nutrition and fluids. Aminophylline is a medicine we know from previous research that improves the function of the diaphragm, the major breathing muscle. Aminophylline also stimulates the respiratory centre in the brain, which stimulates the body to breathe. This tells us that aminophylline might be a helpful drug to use when treating children with severe bronchiolitis. Some doctors use this medicine because they believe it works. Others do not use this medicine because they do not believe it works. The purpose of this research project is to see whether aminophylline makes a difference in the treatment of children with bronchiolitis. We will compare a group of children who receive the standard treatment for bronchiolitis with a group of children who receive the standard treatment and aminophylline. We will compare the duration of mechanical ventilation and the length of intensive care and hospital stay in both groups.


Eligibility

Sex: Both males and femalesMax Age: 12 Monthss

Plain Language Summary

Simplified for easier understanding

This study tests whether aminophylline can help infants under 12 months old with bronchiolitis (a common viral lung infection) who are sick enough to need intensive care. It is for babies with their first or second episode of wheezing linked to a cold. Babies who have had seizures, severe reactions to aminophylline, or previous heart rhythm problems cannot participate.

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.

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Interventions

Aminophylline will be given, as a continuous infusion, for 3 days (72 hours) or until discharge from the Intensive Care Unit, whichever is sooner

Aminophylline will be given, as a continuous infusion, for 3 days (72 hours) or until discharge from the Intensive Care Unit, whichever is sooner


Locations(1)

New Zealand

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ACTRN12608000608369


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