Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates.
NCT ID: NCT05063149
Last Updated: 2024-08-22
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
500 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-01-18
Study Completion Date
2026-12-31
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Wheezing
LRTI
Premature
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Half of the participants (250) will receive treatment (Broncho-Vaxom) and the other half will receive placebo. Randomization will be stratified for gestational age (moderate (30+0-32+6) vs. late (33+0-35+6) prematurity). In the follow-up study Protea-2, infants from the treatment arm in year 1 will be randomised to receive Broncho-Vaxom or placebo in year 2. Randomisation will stratified for gestational age again, but also for the amount of lower respiratory episodes in year 1 (\<2 vs. \>/=2) Infants from the control arm in year 1 will not receive treatment in year 2.
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study subjects, all study investigators including the principal investigator and treating physicians will be blinded for the allocation during the complete study period. A sealed envelope with the treatment allocation per code is present at the pharmacy to be used only when 1) crucial for a medical emergency, 2) the participant will continue with Protea-2 and the database concerning year 1 is locked for this specific participant, and 3) at trial completion after the last patient last visit.
Study Groups
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Broncho-Vaxom treatment
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.
Group Type
ACTIVE_COMPARATOR
Broncho-Vaxom
Intervention Type
DRUG
Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.
Placebo
Infants in this arm will be given a placebo powder from a capsule that will be indistinguishable from the active study drug.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
OTHER
Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug.
Interventions
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Broncho-Vaxom
Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.
Intervention Type
DRUG
Placebo
Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug.
Intervention Type
OTHER
Other Intervention Names
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OM-85
Broncho-Vaxom concentrate (Bacterial lysate)
Eligibility Criteria
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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
* 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 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.
* 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.
Minimum Eligible Age
6 Weeks
Maximum Eligible Age
10 Weeks
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Leiden University Medical Center
OTHER
Sponsor Role
collaborator
Maastricht University Medical Center
OTHER
Sponsor Role
collaborator
Franciscus Gasthuis
OTHER
Sponsor Role
lead
Responsible Party
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Gerdien Tramper
Pediatrician/clinical researcher, principal investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, Netherlands
Site Status
RECRUITING
Countries
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Netherlands
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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NL76165.100.20
Identifier Type: -
Identifier Source: org_study_id
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Inhaled Ciclesonide Study in Preterm Infants
NCT06589245
RECRUITING
PHASE1
A 24 Month Observational Study of Infants 3-24 Months, Who Suffer an Acute Episode of Respiratory Infection and Wheezing Illness
NCT03741322
COMPLETED
Inhaled Beclomethasone to Prevent Chronic Lung Disease
NCT00000576
COMPLETED
PHASE3
Treatment of Persistent Wheezing in Infants and Children
NCT00301171
COMPLETED
NA