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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

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

    • North Carolina
      • Durham, North Carolina, États-Unis, 27710
        • Duke University Medical Center

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
Infants ages 3-24 months with respiratory infections

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Persistent Asthma Phenotype (PAP)
Délai: Measured at 24 months
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).
Measured at 24 months

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
Up to 24 months
Pulmonary Function Testing (iPFT)
Délai: Measured at 24 months
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.
Measured at 24 months
Presence or absence of Loose Asthma Predictive Indices
Délai: 24 months
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.
24 months
Presence or absence of Strict Criteria for API
Délai: 24 months
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.
24 months
Presence or absence of Modified API
Délai: 24 months
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.
24 months

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

Autres numéros d'identification d'étude

  • Pro00100494

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

Essais cliniques sur Infections des voies respiratoires

3
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