Protecting Preterm Infants From Respiratory Tract Infections and Wheeze by Using Bacterial Lysates. (PROTEA)

Franciscus Gasthuis

Status and phase: Enrolling; Phase 3

Conditions: Wheezing; Premature; LRTI

Treatments: Other: Placebo; Drug: Broncho-Vaxom

Study type: Interventional

Funder types: Other

Identifiers

NCT05063149

NL76165.100.20

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 6 to 10 weeks old

Volunteers: No Healthy Volunteers

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 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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500 participants in 2 patient groups, including a placebo group

Broncho-Vaxom treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Broncho-Vaxom

Placebo

Placebo Comparator group

Description:

Infants in this arm will be given a placebo powder from a capsule that will be indistinguishable from the active study drug.

Treatment:

Other: Placebo