About this trial
The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.
Eligibility criteria
Qualifiers
Gestational age at delivery between 30+0 and 35+6 weeks
Postnatal age at least 6 weeks at randomization & postmenstrual age at least 37 weeks
Written informed consent by both parents or formal caregivers
Disqualifiers
Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder.
Lower RTI before randomization
Dysmaturity and/or weight < 2.5 kg at age of randomization.
Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy and/or breastfeeding
Trial design
Treatments tested in this trial
- Broncho-Vaxom
- Placebo
Treatment groups
Sponsors and collaborators
Franciscus Gasthuis
Lead sponsor
Leiden University Medical Center
Collaborator
Maastricht University Medical Center
Collaborator