Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.

PHASE3RecruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

January 18, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
WheezingLRTIPremature
Interventions
DRUG

Broncho-Vaxom

Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.

OTHER

Placebo

Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug.

Trial Locations (1)

3045PM

RECRUITING

Franciscus Gasthuis & Vlietland, Rotterdam

All Listed Sponsors
collaborator

Leiden University Medical Center

OTHER

collaborator

Maastricht University Medical Center

OTHER

lead

Franciscus Gasthuis

OTHER