Exhaled Nitric Oxide Levels in Infants and Young Children Infected With RSV or Other Viral Infections

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Winthrop University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Winthrop University Hospital
ClinicalTrials.gov Identifier:
NCT01098227
First received: March 18, 2010
Last updated: April 1, 2010
Last verified: April 2010
  Purpose

The fraction of exhaled nitric oxide (FeNO) in expired air is a reliable measure of airway inflammation and has been used as a marker in asthma and other respiratory illnesses such as primary ciliary dyskinesia, bronchopulmonary dysplasia (BPD), liver cirrhosis, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF). Although, some exquisite bench research experiments have demonstrated stimulation of nitric oxide production in respiratory epithelial cells infected with RSV, there is a paucity of clinical data regarding levels of feNO in viral respiratory illness and specifically RSV.

The investigators conducted a pilot study from the fall of 2007 until October of 2009, looking at FeNO levels in RSV infected patients and compared it to non-RSV viral infections. The investigators recruited a total of 28 RSV positive and 1 RSV negative subjects, as well as 4 control subjects. The investigators found FeNO values not statistically significant between the study group (the two-tailed p=0.09, considered not quite significant), but there was a trend of higher FeNO values in the non-RSV group when compared to the RSV group. A larger sample may detect a statistically significance between these 2 groups.

Objectives:

i. To determine if the fraction of exhaled nitric oxide (feNO) is elevated in hospitalized pediatric patients with viral lower respiratory illness when compared with normal subjects without respiratory symptoms.

ii. To determine if there is a difference in feNO level between RSV and non-RSV infection in hospitalized pediatric patients with viral lower respiratory illness.

Method of feNO measurement utilized the offline options for preschool children & infants appropriate for age as described in the 2005 Joint Statement of the American Thoracic Society & the European Respiratory Society when discussing tidal breathing techniques with uncontrolled flow rate.

The investigators plan that our sample sizes for the RSV+ and control groups will be, by design, three times as large as the RSV- group. In order to achieve 80% power, the investigators will then require 45 control and 45 RSV+ patients, and 15 RSV- patients


Condition
Bronchiolitis
Infection
Nitric Oxide

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Prospective Study Measuring Exhaled Nitric Oxide Levels in Infants and Young Children Admitted to the Hospital for Respiratory Syncytial Virus (RSV) or Other Viral Lower Respiratory Tract Infections

Resource links provided by NLM:


Further study details as provided by Winthrop University Hospital:

Primary Outcome Measures:
  • To determine if the fraction of exhaled nitric oxide (feNO) is elevated in hospitalized pediatric patients with viral lower respiratory illness when compared with normal subjects without respiratory symptoms [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • To determine if there is a difference in feNO level between RSV and non-RSV infection in hospitalized pediatric patients with viral lower respiratory illness [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Exhaled air for Nitric Oxide measurement


Estimated Enrollment: 105
Study Start Date: January 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
RSV positive subjects
Subjects admitted to Winthrop University Hospital with lower viral respiratory infection and RSV positive status by DFA and/or Viral culture
RSV negative subjects
Subjects admitted to Winthrop University Hospital with a lower viral respiratory infection and RSV status negative by DFA and viral culture. these subjects may be positive for other viruses detected by DFA or viral culture (Adenovirus, Influenza A or B, Metapneumovirus or parainfluenza) or not
Control group
Children in the same age range without respiratory conditions and who are well enough to perform the test from the out patient setting

  Eligibility

Ages Eligible for Study:   up to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Children admitted to Winthrop University Hospital with lower respiratory tract viral illness, bronchiolitis or pneumonia.

The control group will include children in the same age range without respiratory conditions and who are well enough to perform the test from the out patient setting

Criteria

Inclusion Criteria:

  • Consecutive children admitted to WUH with a diagnosis of bronchiolitis, viral pneumonia or other significant respiratory viral infection
  • The control group will include patient within the same age range as the study group who comes to the pediatric office for a well child visit and has none of the exclusion criteria listed below

Exclusion Criteria:

  • Subjects who do not meet the diagnosis for bronchiolitis, viral pneumonia or other significant respiratory viral infection; all patients with underlying diagnosis of asthma/RAD, recurrent wheezing, "recurrent bronchiolitis", allergic rhinitis, atopy, any chronic lung disease, hypertension, heart failure, kidney failure receiving or not dialysis, pulmonary hypertension, primary ciliary dyskinesia, bronchiectasis, alveolitis, lung transplant rejection, pulmonary sarcoidosis, chronic cough (i.e. greater four weeks), systemic sclerosis, hypersensitivity, cystic fibrosis, HIV, sickle cell anemia, cardiac pulmonary bypass, liver cirrhosis, alpha-1 anti-trypsin disease and interstitial lung.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01098227

Contacts
Contact: Claudia Fernandez, MD 516-663-3832 cfernandez@winthrop.org
Contact: Maria L Quintos-Alagheband, MD 516-663-6920 LQuintos@winthrop.org

Locations
United States, New York
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Contact: Claudia Fernandez, MD    516-663-3832    cfernandez@winthrop.org   
Contact: Maria L Quintos-Alagheband, MD    516-663-6920    LQuintos@winthrop.org   
Principal Investigator: Maria L Quintos-Alagheband, MD         
Sub-Investigator: Claudia Fernandez, MD         
Sub-Investigator: Melodi Pirzada, MD         
Sub-Investigator: Leonard Krilov, MD         
Sub-Investigator: Jon Roberts, MD         
Sub-Investigator: Claudia Halaby, MD         
Sub-Investigator: Roopa Siddaiah, MD         
Sponsors and Collaborators
Winthrop University Hospital
Investigators
Principal Investigator: Maria L Quintos-Alagheband, MD Winthrop University Hospital
  More Information

Publications:

Responsible Party: Maria Lyn Quintos-Alagheband MD, Winthrop University Hospital
ClinicalTrials.gov Identifier: NCT01098227     History of Changes
Other Study ID Numbers: 147914
Study First Received: March 18, 2010
Last Updated: April 1, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Winthrop University Hospital:
RSV Bronchiolitis
Lower Respiratory Viral infection
Exhaled Nitric Oxide

Additional relevant MeSH terms:
Bronchiolitis
Respiratory Tract Infections
Virus Diseases
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Infection
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on July 29, 2014