The Effect of Oral Bacterial Lysate to Prevent Persistent Wheeze in Infants After Severe Bronchiolitis; a Randomised Placebo-controlled Trial

Queensland University of Technology0 个研究点目标入组 894 人开始时间: 2021年11月16日最近更新: 2022年10月24日

适应症

试验速览

暂无简介。

•Parent/Guardian able to provide written informed consent
•- Within 6 weeks of discharge from hospital for bronchiolitis
•- Child aged 3-12 months at the time of consent to study
•- A diagnosis of Bronchiolitis requiring a hospital admission (defined as more than 4 hours in hospital)
•- Contactable for regular follow up by the research team

•- Any previous hospital attendance for bronchiolitis
•- More than one episode of healthcare professional-diagnosed wheeze prior to index bronchiolitis episode
•- Premature gestational age less than 37 weeks
•- Any severe chronic condition such as cystic fibrosis, sickle cell disease, severe developmental delay, immunodeficiency, or anything that has a significant impact on the respiratory tract (such as need for non-invasive ventilation) or increases vulnerability to respiratory tract infections.
•- History of clinically significant neonatal disease (e.g. neonatal pneumonia, congenital lung abnormality, neonatal chronic lung disease)
•- Genetic conditions that affect the immune system (e.g. Down's syndrome/Trisomy 21)
•- Current regular oral montelukast or inhaled corticosteroid therapy or inhaled salbutamol therapy
•- Current regular treatment with immunomodulatory drugs (e.g oral steroids)
•- Known allergy or previous intolerance to study medication.
•- Currently enrolled to another RCT. (Unless prior approval is given by PI)
•- Sibling of a BLIPA participant (of the same household or family)

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