Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.
- Registration Number
- NCT05063149
- Lead Sponsor
- Franciscus Gasthuis
- Brief 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.
- Detailed Description
This is a randomised placebo-controlled trial including 500 otherwise healthy moderate-late preterm infants. Participants will receive bacterial lysate (OM-85/Broncho-Vaxom, 3,5mg) or placebo powder for ten days each month, from 6-10 weeks after birth until 12 months after birth. At 12 months, parents of participants are asked to join in Protea-2. If they do, participants in the treatment arm of year 1 are randomised again over placebo and OM-85 and treated until the age of 24 months. Clinical data will be continuously collected by e-Health and 3 (possibly digital) study visits; with optional biological sampling and lung function at baseline, 6 and 12 months. And in case of participation in Protea-2 also at 24 months.
Main study parameters are doctor diagnosed lower RTI and wheezing episodes in the first year of life. Biological sampling will allow investigation of immune maturation, as well as microbiome development in the respiratory tract and gut. Also, biomarkers for risk-group selection and/or treatment success will be examined.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
- Underlying other severe respiratory disease such as broncho-pulmonary dysplasia (unexpected in this group); hemodynamic significant cardiac disease; immunodefi-ciency; severe failure to thrive; birth asphyxia with predicted poor neurological out-come; syndrome or serious congenital disorder.
- Lower RTI before randomization
- Dysmaturity and/or 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 excipients.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Broncho-Vaxom treatment Broncho-Vaxom Infants in this arm will be given 3,5mg bacterial lysate (OM-85) 10 days per month from 6 weeks after birth until 12 months of age. At age 12 months they will be (if informed consent for Protea-2 is provided) randomised over Broncho-Vaxom treatment and placebo again. Placebo Placebo Infants in this arm will be given a placebo powder from a capsule that will be indistinguishable from the active study drug.
- Primary Outcome Measures
Name Time Method Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life In the first year of life. Recorded by frequent questionnaires
- Secondary Outcome Measures
Name Time Method Lung function as measured by expiratory variability index (Ventica) In the first year of life. Measured at age 6-10 weeks (baseline), 6 months and 12 months in a subset of participants.
Medication use (bronchodilators, corticosteroids, antibiotics) In the first and second year of life. Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life.
Total number of wheezing episodes In the first and second year of life. Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life.
Total number of RTI In the first and second year of life. Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life.
Distribution of viruses In the first year of life. Viruses present in the nasofarynx during complaints of lower respiratory tract infection or wheezing. Nasofaryngeal swabs will be taken in case of complaints during the first year of life. In the second year of life this will not be done.
Quality of life questionnaires In the first and second year of life. Recorded by extensive questionnaires every six months in the first and second year of life.
Serum specific IgE (allergen sensitization) at 12 months At age 12 months Total IgE and house dust mite specific IgE
Costs- and cost-effectiveness In the first and second year of life. Estimated from information from standardized questionnaires
Time to first lower RTI or wheezing episode In the first and second year of life. Recorded by short weekly questionnaires (which will be filled in during the first year of life) and more extensive questionnaires every six months in the first and second year of life.
(serious) adverse events In the first year of life. Will be reported by parents immediately. Respiratory episodes are not regarded as an (S)AE since these episodes comprise primary and secondary outcomes. (S)AE's are only expected in the first year of life because the treatment stops at the age of 12 months.
Infant vaccination titers at 12 months At age 12 months Vaccination titers of haemohilus influenza type B, pneumococci, tetanus
Trial Locations
- Locations (1)
Franciscus Gasthuis & Vlietland
🇳🇱Rotterdam, Zuid-Holland, Netherlands