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.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000608369

Enrollment

Registered

2008-12-04

Start date

2002-10-05

Completion date

2009-09-14

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to 12 Months

Healthy volunteers

Inclusion criteria

Clinical diagnosis of bronchiolitis, defined as a first or second episode of wheezing or respiratory distress associated with an upper respiratory tract infection Admission to a paediatric intensive care unit

Exclusion criteria

Contraindication to aminophylline (previous severe reaction, previous atrial or ventricular arrythmia, previous seizures, previous liver dysfunction) Episode of apnoea requiring treatment with aminophylline Previous admission to the study Pertussis isolated on nasopharyngeal aspirate

Outcome results