A 24 Month Observational Study of Infants 3-24 Months, Who Suffer an Acute Episode of Respiratory Infection and Wheezing Illness

Completed

Conditions studied: Respiratory Tract Infections, Wheezing

In brief

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.

Key facts

Study ID

NCT03741322

Run by

Duke University

People needed

5

Starts

2018-12-12

Expected to finish

2020-06-16

Last updated by the study team

2020-11-25

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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