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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
EU CTIS ID: 2024-518498-32-01
What this study is testing
We hypothesize that early education of the neonatal immune system by daily stimulation with microbial elements leads to better protection against lower RTI and subsequent wheezing episodes. It enhances self-initiated antimicrobial immunity by improved and accelerated immune maturation. This will lead to a significant health gain in preterm-born infants with enhanced risk for respiratory diseases. Moreover, we hypothesize that prolonged bacterial lysate therapy after preterm birth leads to a delay in lower respiratory tract symptoms compared to a shorter treatment. Thus, our main objective is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first years of life by bacterial lysate administration.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (un-expected in this group); hemodynamic significant cardiac disease; immunodeficiency; severe failure to thrive; birth asphyxia with predicted poor neurological outcome; syn-drome or serious congenital disorder.
- 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 ex-cipients.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.