Wheezing Clinical Trial
— PROTEAOfficial title:
Protecting Late-moderate Preterm Infants From Respiratory Tract Infections and Wheeze in Their First Year of Life by Using Bacterial Lysates.
The primary objective of this study is to reduce respiratory tract infections and wheezing in moderate-late preterms in the first year of life by bacterial lysate administration. Next to determine the correlation of biological markers with respiratory symptoms, immune protection and treatment effect.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | December 2026 |
Est. primary completion date | December 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Weeks to 10 Weeks |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Franciscus Gasthuis & Vlietland | Rotterdam | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Franciscus Gasthuis | Leiden University Medical Center, Maastricht University Medical Center |
Netherlands,
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* Note: There are 45 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Gut and respiratory microbiome composition | Measured from faeces and nasofaryngeal swabs taken at age 6-10 weeks, 6 months and 12 months. | In the first year of life. | |
Other | Secretory IgA in saliva | Saliva will be collected at age 6-10 weeks, 6 months and 12 months. | In the first year of life | |
Other | Immune maturation: immune cells in nasal epithelium | Collected by nasal scraping at age 6-10 weeks, 6 months and 12 months. Analysed using masscytometry. | In the first year of life | |
Other | Immune maturation: chemokines and cytokines in nasal lining fluid | Collected by nasosorption at age 6-10 weeks, 6 months and 12 months. Analysed using Luminex cyto/chemokine assay. | In the first year of life | |
Other | Immune maturation: immune cells in bloodsamples | Collected by blooddraws at age 6-10 weeks, 6 months and 12 months. Analysed using masscytometry. | In the first year of life | |
Other | Serum IgE (total and specific to house dust mite) | Measured in blood samples which will be drawn at age 12 months | At age 12 months | |
Other | Immune maturation: Single cell transcriptomics | Performed on blood drawn at age 12 months | At age 12 months | |
Other | Whole blood stimulation essays | Performed on blood drawn at age 12 months | At age 12 months | |
Other | Biomarkers predictive of high morbidity and/or treatment success | From combined microbial and immunological data | In the first year of life. | |
Primary | Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life | Recorded by frequent questionnaires | In the first year of life. | |
Secondary | Time to first lower RTI or wheezing episode | 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. | In the first and second year of life. | |
Secondary | Total number of RTI | 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. | In the first and second year of life. | |
Secondary | Total number of wheezing episodes | 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. | In the first and second year of life. | |
Secondary | Distribution of viruses | 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. | In the first year of life. | |
Secondary | Medication use (bronchodilators, corticosteroids, antibiotics) | 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. | In the first and second year of life. | |
Secondary | Lung function as measured by expiratory variability index (Ventica) | Measured at age 6-10 weeks (baseline), 6 months and 12 months in a subset of participants. | In the first year of life. | |
Secondary | Quality of life questionnaires | Recorded by extensive questionnaires every six months in the first and second year of life. | In the first and second year of life. | |
Secondary | (serious) adverse events | 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. | In the first year of life. | |
Secondary | Serum specific IgE (allergen sensitization) at 12 months | Total IgE and house dust mite specific IgE | At age 12 months | |
Secondary | Infant vaccination titers at 12 months | Vaccination titers of haemohilus influenza type B, pneumococci, tetanus | At age 12 months | |
Secondary | Costs- and cost-effectiveness | Estimated from information from standardized questionnaires | In the first and second year of life. |
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