Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.
Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.
Franciscus Gasthuis
500 participants
Jan 18, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria6
- 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.
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Interventions
Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.
Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05063149