Ochrana předčasně narozených dětí před infekcemi dýchacích cest a sípáním pomocí bakteriálních lyzátů. (PROTEA)
Ochrana předčasně narozených dětí v pozdním věku před infekcemi dýchacích cest a sípáním v prvním roce života pomocí bakteriálních lyzátů.
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.
Přehled studie
Detailní popis
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.
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 3
Kontakty a umístění
Studijní kontakt
- Jméno: Gerdien Tramper, MD PhD
- Telefonní číslo: 0031 10 4617126
- E-mail: proteastudie@franciscus.nl
Studijní místa
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South Holland
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Rotterdam, South Holland, Holandsko, 3045PM
- Nábor
- Franciscus Gasthuis & Vlietland
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Kontakt:
- Gerdien Tramper, MD PhD
- Telefonní číslo: +311046117126
- E-mail: proteastudie@franciscus.nl
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Kontakt:
- E-mail: wetenschapsbureau@franciscus.nl
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
- 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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: 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. |
Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.
Ostatní jména:
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Komparátor placeba: Placebo
Infants in this arm will be given a placebo powder from a capsule that will be indistinguishable from the active study drug. |
Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life
Časové okno: In the first year of life.
|
Recorded by frequent questionnaires |
In the first year of life.
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Time to first lower RTI or wheezing episode
Časové okno: In the first and second year of life.
|
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.
|
|
Total number of RTI
Časové okno: In the first and second year of life.
|
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.
|
|
Total number of wheezing episodes
Časové okno: In the first and second year of life.
|
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.
|
|
Distribution of viruses
Časové okno: In the first year of life.
|
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.
|
|
Medication use (bronchodilators, corticosteroids, antibiotics)
Časové okno: In the first and second year of life.
|
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.
|
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Lung function as measured by expiratory variability index (Ventica)
Časové okno: In the first year of life.
|
Measured at age 6-10 weeks (baseline), 6 months and 12 months in a subset of participants. |
In the first year of life.
|
|
Quality of life questionnaires
Časové okno: In the first and second year of life.
|
Recorded by extensive questionnaires every six months in the first and second year of life. |
In the first and second year of life.
|
|
(serious) adverse events
Časové okno: In the first year of life.
|
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.
|
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Serum specific IgE (allergen sensitization) at 12 months
Časové okno: At age 12 months
|
Total IgE and house dust mite specific IgE |
At age 12 months
|
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Infant vaccination titers at 12 months
Časové okno: At age 12 months
|
Vaccination titers of haemohilus influenza type B, pneumococci, tetanus |
At age 12 months
|
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Costs- and cost-effectiveness
Časové okno: In the first and second year of life.
|
Estimated from information from standardized questionnaires |
In the first and second year of life.
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Gut and respiratory microbiome composition
Časové okno: In the first year of life.
|
Measured from faeces and nasofaryngeal swabs taken at age 6-10 weeks, 6 months and 12 months. |
In the first year of life.
|
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Secretory IgA in saliva or nasal lining fluid
Časové okno: In the first year of life
|
Saliva will be collected at age 6-10 weeks, 6 months and 12 months. |
In the first year of life
|
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Immune maturation: immune cells in nasal epithelium
Časové okno: In the first year of life
|
Collected by nasal scraping at age 6-10 weeks, 6 months and 12 months. Analysed using masscytometry. |
In the first year of life
|
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Immune maturation: chemokines and cytokines in nasal lining fluid
Časové okno: In the first year of life
|
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
|
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Immune maturation: immune cells in bloodsamples
Časové okno: In the first year of life
|
Collected by blooddraws at age 6-10 weeks, 6 months and 12 months. Analysed using masscytometry. |
In the first year of life
|
|
Serum IgE (total and specific to house dust mite)
Časové okno: At age 12 months
|
Measured in blood samples which will be drawn at age 12 months |
At age 12 months
|
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Immune maturation: Single cell transcriptomics
Časové okno: At age 12 months
|
Performed on blood drawn at age 12 months |
At age 12 months
|
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Whole blood stimulation essays
Časové okno: At age 12 months
|
Performed on blood drawn at age 12 months |
At age 12 months
|
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Biomarkers predictive of high morbidity and/or treatment success
Časové okno: In the first year of life.
|
From combined microbial and immunological data |
In the first year of life.
|
Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
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Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Porodnický porod, předčasný
- Porodnické porodní komplikace
- Těhotenské komplikace
- Infekce
- Nemoci dýchacích cest
- Příznaky a symptomy, Respirační
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Předčasný porod
- Infekce dýchacích cest
- Respirační zvuky
- Broncho-Vaxom
Další identifikační čísla studie
- NL76165.100.20
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Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Researchdata will be shared in data repositories according to the FAIR principle. Clinical data about respiratory health will be shared in the DANS repository. Inlcuding metadata which will ensure reusability. Sequencing data will be shared online in the ENA repository which will provide an unique global identifier. All used bioinformatics pipelines for data analysis will be made accessible on a GitHub account. Immunological data will be shared in NCBI Gene Expression omnibus and ImmPort. Used analysis pipelines for the transcriptomics data will also be tracked and can be shared using a Github account.
All data shared will be pneudonymized.
Časový rámec sdílení IPD
Data will come available after publication of the data in articles by initating researchers.
Kritéria přístupu pro sdílení IPD
Data will be available under restricted access. A request for data sharing will include at least the reason for request (for what will the receiver use the data?) and agreements about authorship.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .