Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

NCT00435994 | Completed Results DMC

• 1 other identifier: 0311-21
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how two different aerosol medications may improve airway function in infants with respiratory illness. We are using two different medications and comparing the difference in lung function after each medication. We will also be taking a nasal wash sample for VEGF. We will be using this in comparing how infants respond to the aerosol medications as well. We hope to help standardize medications used for infants with bronchiolitis and RSV.

Conditions

Bronchiolitis; Respiratory Syncytial Virus Infections

Keywords

Infant; Respiratory Syncytial Virus; Bronchiolitis

Outcome Measures

Primary Outcomes (2)

• Lung Function

  Lung functions were obtained under sedation using Chloral Hydrate. Forced expiratory flows are a lung volume at which the airway pressure is equal to 30 cm H2O (V30). Forced expiratory flows are measured at 75% FVC (FEF75). Measurements were repeated post bronchodilator and again post Epinephrine. A higher Z-score reflects better lung function.

  Baseline, Post bronchodilator (up to 10 minutes, Post-epinephrine (up to 30 minutes)

• Endothelial Growth Factor (VEGF)

  Analysis for VEGF level by ELISA

  During nasal wash

Study Arms (3)

Infants with viral lower respiratory infections

OTHER

Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by an upper respiratory tract infection, including hospitalized infants

Drug: Inhaled primatene will be given as a breathing treatment; Other: Nasal Washing

Healthy Control

OTHER

Healthy infants between the ages of 2-24 month

Drug: Inhaled primatene will be given as a breathing treatment; Other: Nasal Washing

Bronchiolitis-Nasal wash only

OTHER

Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only

Other: Nasal Washing

Interventions

Inhaled primatene will be given as a breathing treatment DRUG

While the research subject is sedated an inhaled mist of primatene mist will be given to the patient.

Also known as: epinephrine 0.5ml of the 2.25% concentration

Healthy Control; Infants with viral lower respiratory infections

Nasal Washing OTHER

1-3 mls of normal saline will be instilled into the infant's nose and then aspirated to obtain the nasal fluid, which will be analyzed for VEGF level by ELISA and viral antigens by immunoflourescence

Bronchiolitis-Nasal wash only; Healthy Control; Infants with viral lower respiratory infections

Eligibility Criteria

• Age: 2 Months - 2 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Group 1 Infants between 2 and 24 months that are healthy
• Group 2 Infants between 2 and 24 months that have RSV or bronchiolitis and defined as the first episode of wheezing

You may not qualify if:

• Group 1 and 2 - no cardiac disease, no oxygen requirement, prematurity \< 37 weeks, and cannot be in the ICU.

Sponsors & Collaborators

• Indiana University School of Medicine: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Bronchiolitis; Respiratory Syncytial Virus Infections

Interventions

Epinephrine; Nasal Lavage Fluid

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Nasal Lavage; Therapeutic Irrigation; Investigative Techniques

Limitations and Caveats

More than half of our infants woke up before completion of the protocol therefore limiting our analysis.

Results Point of Contact

• Title: Robert Tepper, MD, Ph.D.
• Organization: Indiana University

rtepper@iu.edu

317-274-9647

Study Officials

• Robert S. Tepper, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2007
• First Posted: February 16, 2007
• Study Start: December 1, 2003
• Primary Completion: March 1, 2009
• Study Completion: December 1, 2012
• Last Updated: June 1, 2016
• Results First Posted: June 1, 2016

Record last verified: 2016-05

Locations

US (1)