Broncho-Vaxom: Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.
Placebo: Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug.
Study 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
Sex
ALL
Min age
6 Weeks
Max age
10 Weeks
Healthy volunteers
No
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.
* 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.
Primary outcome measure(s)
Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life — In the first year of life. Recorded by frequent questionnaires
Trial sites (1)
Facility
City
Region
Status
Franciscus Gasthuis & Vlietland
Rotterdam
South Holland
Recruiting
More Franciscus Gasthuis trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.