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Protecting late-moderate preterm infants from respiratory tract infections and wheeze in their first year of life by using bacterial lysates

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518498-32-01
Enrollment
500
Registered
2024-12-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower respiratory tract infections and wheezing in moderate-late premature infants

Brief summary

Protea-1: Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life., Protea-2: The time to the first lower respiratory episode after 12 months of age.

Detailed description

time to first lower RTI or wheezing episode in the first year of life, total number of RTI in the first and second year of life, total number of wheezing episodes in the first and second year of life, distribution of viruses during lower RTI/wheezing, medication use (bronchodilators, corticosteroids, antibiotics), lung function as measured by expiratory variability index, quality of life, (serious) adverse events (respiratory episodes are not regarded as an (S)AE since they comprise primary and secondary outcomes), serum specific IgE (allergen sensitization) at 12 months, infant vaccination titers at 12 months, costs- and cost-effectiveness

Interventions

DRUGBRONCHO-VAXOM Kinderen
DRUGhard

Sponsors

Sint Franciscus Vlietland Groep Stichting
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
Protea-1: Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life., Protea-2: The time to the first lower respiratory episode after 12 months of age.

Secondary

MeasureTime frame
time to first lower RTI or wheezing episode in the first year of life, total number of RTI in the first and second year of life, total number of wheezing episodes in the first and second year of life, distribution of viruses during lower RTI/wheezing, medication use (bronchodilators, corticosteroids, antibiotics), lung function as measured by expiratory variability index, quality of life, (serious) adverse events (respiratory episodes are not regarded as an (S)AE since they comprise primary and secondary outcomes), serum specific IgE (allergen sensitization) at 12 months, infant vaccination titers at 12 months, costs- and cost-effectiveness

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026