Protecting late-moderate preterm infants from respiratory tract infections and wheeze in their first yearsof life by using bacterial lysates.

Phase 3

Recruiting

Conditions: respiratory tract infections and wheezing
10047438
10024970

Registration Number: NL-OMON55914

Lead Sponsor: Franciscus Gasthuis & Vlietland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 500

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;
immunodeficiency; severe failure to thrive; birth asphyxia with predicted poor
neurological out-come; syndrome or serious congenital disorder.
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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Doctor diagnosed lower RTI and wheezing episodes in the first year of life.<br /><br>Time to first lower respiratory episodes in the second year of life.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• time to first lower RTI or wheezing episode<br /><br>• total number of RTI<br /><br>• total number of wheezing episodes<br /><br>• distribution of viruses<br /><br>• medication use (bronchodilators, corticosteroids, antibiotics)<br /><br>• lung function as measured by expiratory variability index<br /><br>• quality of life<br /><br>• costs- and cost-effectiveness<br /><br>• (serious) adverse events<br /><br>• serum specific IgE (allergen sensitization) at 12 months<br /><br>• infant vaccination titers at 12 months<br /><br>• immune development trajectories; immune maturation<br /><br>• gut and respiratory microbiome composition<br /><br>• biomarkers predictive of high morbidity and/or treatment success </p><br>