Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.
Trial Parameters
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Parents unable to speak and read Dutch/English language * Known allergic hypersensitivity to the active ingredients/substance or to any of the excipients.