- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03741322
A 24 Month Observational Study of Infants 3-24 Months, Who Suffer an Acute Episode of Respiratory Infection and Wheezing Illness (BIOPA)
24 novembre 2020 mis à jour par: Duke University
Respiratory BIOmarkers in Viral Wheezing That Predict Asthma
This study will identify infants between the age of 3 and 24 months of age who are experiencing one of their first acute respiratory infections with confirmed wheezing.
Infants who are also confirmed to be wheezing and whose caregiver signs consent will be enrolled from a primary care clinic, emergency room or hospital.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
BACKGROUND: Respiratory virus infections are extremely common in young children.
These infections typically lead to inflammation and constriction of the airways, which is termed bronchiolitis.
Bronchiolitis is the leading cause of hospitalization for infants with respiratory infections, with an average of 120,000 children under the age of one hospitalized every year.
Viral infection by Respiratory Syncytial Virus (RSV), rhinoviruses, or influenza viruses is thought to be by far the major driver of bronchiolitis.
The children who need to be hospitalized with bronchiolitis have a drastically increased chance (about 45%) of developing chronic respiratory diseases such as wheezing or asthma.
The disease of asthma affects children more than adults, and the Centers For Disease Control states that asthma is the most chronic condition among children under the age of 18, affecting more than 6 million (or 8.4%) children in the US.
Due to this prevalence, asthma is the third leading cause of hospitalization among children under the age of 15 years, with the annual direct healthcare costs at ~$50 billion every year.
The economic costs associated with parental lost productivity is another ~$6 billion every year.
The American Lung Association states that asthma is also one of the leading causes of school absenteeism, with an estimated 13.8 million lost school days every year.
While asthma can be managed with bronchodilator inhalers, there is not a single treatment designed to prevent or reverse asthma disease.
Understanding how viral infection causes initial bronchiolitis and maintains the chronic inflammation that leads to asthma will lead to new treatments that prevent or reverse chronic lung diseases.
This research has the potential to change everyday life for millions of children and their families in the US.
Type d'étude
Observationnel
Inscription (Réel)
5
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Carolina
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Durham, North Carolina, États-Unis, 27710
- Duke University Medical Center
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
3 mois à 2 ans (Enfant)
Accepte les volontaires sains
N/A
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
Participants will be offered enrollment into the study via Institutional Review Board-approved methods including review of newly hospitalized patients to Duke Children's Hospital, patients seen in the Duke Children's Hospital Emergency Room, and patients seen in a Duke Children's ambulatory clinics.
Consent: The study will be explained to the participant and caregiver by trained study staff (Principal Investigator, Co-Investigator, research coordinator or research assistant).
La description
Inclusion Criteria:
- Documented informed consent from legal guardian prior to study procedures
- Age: 3-24 months at the time of visit 1
- Severe lower respiratory wheezing illness confirmed by auscultation requiring hospitalization or acute care (Emergency Department care or unscheduled ambulatory care)
Exclusion Criteria:
- No prior hospital admissions for wheezing illnesses
- No prior diagnosis of asthma or Reactive Airways Disease
- More than 1 prior episode of wheezing confirmed by auscultation
- No congenital or chronic disease which would negatively affect the conduct of the study (e.g. childhood cancer, cystic fibrosis, interstitial lung disease, prior aero-digestive surgery)
- No diagnosis of bronchopulmonary dysplasia
- No premature birth (gestational age < 32 weeks)
- Daily treatment with a daily asthma controller (e.g. Montelukast, inhaled corticosteroid)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Infants ages 3-24 months with respiratory infections
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Persistent Asthma Phenotype (PAP)
Délai: Measured at 24 months
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Participants will be assessed for meeting criteria for the persistent asthma phenotype which will be defined as meeting any Asthma Predicative Indices plus abnormal lung pulmonary function testing by Impulse oscillometry (either from peripheral airway resistance or bronchodilator responsiveness).
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Measured at 24 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Total confirmed Respiratory tract infections as measured by nasal secretion sampling.
Délai: Up to 24 months
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Up to 24 months
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Pulmonary Function Testing (iPFT)
Délai: Measured at 24 months
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Impulse Oscillometry (IOS) simply requires the child to breathe in and out through a mouthpiece for 20-30 seconds.
During breathing, a loudspeaker delivers a quiet pulse-shaped pressure-flow signal to the respiratory system.
The overall respiratory system impedance (Z) is measured and reflects the resistive and viscoelastic forces of the respiratory system determined from the returning signal.
Outcome data are reported as respiratory system resistance (R) and reactance (X) measured in centimeters of water per liter per second.
Measurements from the 3 efforts for each outcome parameter will be averaged for the final result.
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Measured at 24 months
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Presence or absence of Loose Asthma Predictive Indices
Délai: 24 months
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Lose API is based on based on any wheezing in first 3 years of life plus, One of the following two: Parental asthma or child eczema, AND Two of the following three: eosinophilia, wheezing without colds, and allergic rhinitis.
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24 months
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Presence or absence of Strict Criteria for API
Délai: 24 months
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Strict API is measured based on Early Frequent wheezing in first 3 years of life plus, One of the following two: Parental asthma or child eczema, AND Two of the following three: eosinophilia, wheezing without colds, and allergic rhinitis.
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24 months
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Presence or absence of Modified API
Délai: 24 months
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Modified API is measured based on ≥4 wheezing episodes in a year plus, One of the following two: Parental asthma or child eczema or allergic sensitization to at least one aeroallergen, AND Two of the following three: eosinophilia, wheezing without colds, and allergic sensitization to milk, egg or peanuts.
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24 months
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jason Lang, MD, MPH, Duke University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
12 décembre 2018
Achèvement primaire (Réel)
16 juin 2020
Achèvement de l'étude (Réel)
16 juin 2020
Dates d'inscription aux études
Première soumission
25 octobre 2018
Première soumission répondant aux critères de contrôle qualité
12 novembre 2018
Première publication (Réel)
14 novembre 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
25 novembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 novembre 2020
Dernière vérification
1 novembre 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Pro00100494
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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Non
Étudie un produit d'appareil réglementé par la FDA américaine
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