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Completed

NCT Number: NCT00435994

Assessment of Airway Obstruction in Infants With Lower Respiratory Infections

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.

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Key information

Conditions

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

Age range

2 month–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

About this study

We hypothesize that VEGF production is higher in children with RSV infection than in children with other viral infections and normal controls. In addition, the degree of VEGF production is related to severity of airway obstruction. We also hypothesize that infants with higher VEGF levels are more likely to improve lung function following racemic epinephrine than albuterol.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

Other names: epinephrine 0.5ml of the 2.25% concentration

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

Primary outcomes

  1. Lung Function

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

    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.

  2. Endothelial Growth Factor (VEGF)

    Time frame: During nasal wash

    Analysis for VEGF level by ELISA

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Thrasher Research Fund

Registry information

Important dates

Study start
2003
Primary completion
2009
Study completion
2012
First posted
Feb 16, 2007
Registry last updated
Jun 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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