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

NCT03741322 | Completed

• 1 other identifier: Pro00100494
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Tract Infections; Wheezing

Outcome Measures

Primary Outcomes (1)

• Persistent Asthma Phenotype (PAP)

  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

Secondary Outcomes (5)

• Total confirmed Respiratory tract infections as measured by nasal secretion sampling.

  Up to 24 months

• Pulmonary Function Testing (iPFT)

  Measured at 24 months

• Presence or absence of Loose Asthma Predictive Indices

  24 months

• Presence or absence of Strict Criteria for API

  24 months

• Presence or absence of Modified API

  24 months

Study Arms (1)

Infants ages 3-24 months with respiratory infections

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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).

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)

Sponsors & Collaborators

• Duke University: lead
• The Hartwell Foundation: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Respiratory Sounds

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason Lang, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2018
• First Posted: November 14, 2018
• Study Start: December 12, 2018
• Primary Completion: June 16, 2020
• Study Completion: June 16, 2020
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)