Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.
Recruiting
Phase 3
Interventional Study
Wheezing
LRTI
Premature
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 Weeks – 10 Weeks
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 500 (estimated)
- Sponsor
- Franciscus Gasthuis · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 …
Contacts