TerminatedPhase 3ACTRN12613000316707

Randomised controlled trial of a combination of Dexamethasone and Adrenaline for infants with Bronchiolitis

Randomised controlled trial of a combination of Dexamethasone and Adrenaline versus standard care to assess duration of positive pressure ventilation for infants admitted to intensive care with Bronchiolitis

Sponsor

Royal Children's Hospital

Enrollment

306 participants

Start Date

Jul 24, 2013

Study Type

Interventional

Conditions

Bronchiolitis

Summary

Bronchiolitis is a common viral infection of the lungs. It is mostly seen in children less than 1 year old, but it does affect children up to 2 years of age. Each year an average of 100 children with severe bronchiolitis need to be admitted for treatment in the intensive care unit. These children experience significant breathing difficulty and many are ill enough to need a machine to help them to breathe. The standard treatment for these children is to support their breathing, and to give them adequate nutrition and fluids. There are no other medications that have been shown to benefit children with bronchiolitis. Steroids and adrenaline are two medicines that are commonly used to treat children with severe croup or asthma, and recent research suggests that they may help children with mild bronchiolitis. Steroids are an anti-inflammatory medicine, and adrenaline helps to expand inflamed narrowed airways. It is possible that using a combination of these medicines may reduce the amount of respiratory support required for those children admitted to the intensive care unit with bronchiolitis. Some doctors already use this medicine in intensive care because they believe it works, but other doctors do not use this medicine because they do not think there is enough evidence that it works in intensive care patients. The purpose of this research project is to see whether dexamethasone (a type of steroid) and adrenaline makes a difference in the treatment of children with bronchiolitis in intensive care. Adrenaline and dexamethasone are medicines that are approved for use in children by the Therapeutic Goods Administration, Australia. We will compare a group of children who receive the standard treatment for bronchiolitis with a group of children who receive the standard treatment plus steroids and adrenaline. We will compare the amount of respiratory support needed, the duration of mechanical ventilation and the length of stay in intensive care and in hospital in both groups. We aim to study a total of 305 children from The Royal Children’s Hospital, Melbourne. This research will also take place at Princess Margaret Hospital for Children in Perth and the Starship Hospital and Middlemore Hopsital in New Zealand.

Eligibility

Sex: Both males and femalesMin Age: 37 WeekssMax Age: 18 Monthss

Inclusion Criteria5

a clinical diagnosis of bronchiolitis, defined as a first or second episode of wheezing or respiratory distress associated with a respiratory tract infection plus either radiological evidence of chest hyperinflation or clinical evidence of prolonged expiration
greater than 37 weeks and less than 18 months of age
no previous admission to this study
admission to intensive care for respiratory distress (not apnoea alone)
recruitment and initiation of the study therapy within 4 hours of admission to intensive care

Exclusion Criteria3

Corrected gestational age of less than 37 weeks at time of admission to the intensive care.
Clinical evidence of croup (laryngotracheobronchitis)
Immunosuppressive treatment, including any dose of corticosteroids in the last 7 days.

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Interventions

While in intensive care, patients in the treatment group will receive 0.6 mg/kg dexamethasone intramuscular or intravenously OR 4mg/kg of oral prednisolone as a loading dose, then 1 mg/kg of methylprednisolone intravenous or prednisolone nasogastric or orally 8 hourly for 9 doses (days1-3 of the study), then daily for three days (days 4-6). The route of administration is determined by the presence of an intravenous cannula or tolerance of oral intake for drugs that can be administered by nasogastric tube. This will be determined by the treating clinician. Starting at the same time as the loading dose of dexamethasone, patients will be given adrenaline providing the resting heart rate is <180 beats per minute: If eligible 5 doses of 0.05ml/kg of 1% adrenaline (or 0.5ml/kg of 1/1000 adrenaline) made up to 6ml with 0.9% saline and nebulised using 12L/min of 02 and repeated every 30 minutes to a total of 5 doses, then given 1-4 hourly depending on the patient response for 72 hours, and then as required for a further 3 days while in intensive care. These drugs were chosen as they are commonly used for other inflammatory diseases of the airway of children and have been used in a recent randomised controlled trial in Canadian emergency department for this condition