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Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.
Sponsor: Franciscus Gasthuis
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.
Official title: Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Years of Life by Using Bacterial Lysates.
Key Details
Gender
All
Age Range
6 Weeks - 10 Weeks
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2022-01-18
Completion Date
2026-12
Last Updated
2024-08-22
Healthy Volunteers
No
Interventions
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.
Locations (1)
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, Netherlands