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

Phase 3

Recruiting

Conditions: Wheezing
LRTI
Premature

Registration Number: NCT05063149

Lead Sponsor: Franciscus Gasthuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 500

Inclusion 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 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.

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life

Secondary Outcome Measures

Name	Time	Method
Lung function as measured by expiratory variability index (Ventica);Time to first lower RTI or wheezing episode;Total number of RTI;Total number of wheezing episodes;Distribution of viruses;Medication use (bronchodilators, corticosteroids, antibiotics);Quality of life questionnaires;(serious) adverse events;Serum specific IgE (allergen sensitization) at 12 months;Infant vaccination titers at 12 months;Costs- and cost-effectiveness