Proteggere i neonati pretermine dalle infezioni del tratto respiratorio e dal respiro sibilante utilizzando lisati batterici. (PROTEA)
Proteggere i neonati pretermine tardivi-moderati dalle infezioni del tratto respiratorio e dal respiro sibilante nel loro primo anno di vita utilizzando lisati batterici.
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 3
Contatti e Sedi
Contatto studio
- Nome: Gerdien Tramper, MD PhD
- Numero di telefono: 0031 10 4617126
- Email: proteastudie@franciscus.nl
Luoghi di studio
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South Holland
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Rotterdam, South Holland, Olanda, 3045PM
- Reclutamento
- Franciscus Gasthuis & Vlietland
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Contatto:
- Gerdien Tramper, MD PhD
- Numero di telefono: +311046117126
- Email: proteastudie@franciscus.nl
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Contatto:
-
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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.
Altri nomi:
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Comparatore placebo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Total number of physician diagnosed lower RTI and wheezing episodes in the first year of life
Lasso di tempo: In the first year of life.
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Recorded by frequent questionnaires |
In the first year of life.
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time to first lower RTI or wheezing episode
Lasso di tempo: 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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Total number of RTI
Lasso di tempo: In the first and second year of life.
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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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Total number of wheezing episodes
Lasso di tempo: 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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Distribution of viruses
Lasso di tempo: 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.
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Medication use (bronchodilators, corticosteroids, antibiotics)
Lasso di tempo: 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)
Lasso di tempo: 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.
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Quality of life questionnaires
Lasso di tempo: 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.
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|
(serious) adverse events
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: At age 12 months
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Vaccination titers of haemohilus influenza type B, pneumococci, tetanus |
At age 12 months
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Costs- and cost-effectiveness
Lasso di tempo: In the first and second year of life.
|
Estimated from information from standardized questionnaires |
In the first and second year of life.
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Gut and respiratory microbiome composition
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
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Serum IgE (total and specific to house dust mite)
Lasso di tempo: 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
Lasso di tempo: At age 12 months
|
Performed on blood drawn at age 12 months |
At age 12 months
|
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Whole blood stimulation essays
Lasso di tempo: 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
Lasso di tempo: In the first year of life.
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From combined microbial and immunological data |
In the first year of life.
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Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
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Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie urogenitali femminili e complicanze della gravidanza
- Travaglio ostetrico, prematuro
- Complicanze ostetriche del lavoro
- Complicazioni della gravidanza
- Infezioni
- Malattie delle vie respiratorie
- Segni e sintomi, respiratori
- Condizioni patologiche, segni e sintomi
- Segni e sintomi
- Nascita prematura
- Infezioni delle vie respiratorie
- Suoni respiratori
- Broncho-Vaxom
Altri numeri di identificazione dello studio
- NL76165.100.20
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Periodo di condivisione IPD
Data will come available after publication of the data in articles by initating researchers.
Criteri di accesso alla condivisione 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .