RSV InfectionNCT01090557
Exhaled Nitric Oxide in Respiratory Syncytial Virus (RSV) Bronchiolitis: a Pilot Study
An observational study of RSV Infection and Bronchiolitis, run by Winthrop University Hospital at 1 site in United States.
Trial summary
The fraction of exhaled nitric oxide (feNO) in expired air is a reliable measure of airway inflammation. Some research experiments have demonstrated stimulation of nitric oxide production in respiratory epithelial cells infected with RSV. Read more about this study
- Who is it for?
- Ages 1 day to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- RSV Infection, Bronchiolitis
- What is being tested?
- Collection of exhaled breath
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The parents of children admitted to WUH with a diagnosis of lower respiratory tract viral illness (LRTVI) will be offered the opportunity to participate
Who may be able to join
- Admitted subjects with diagnosis of bronchiolitis, viral pneumonia or other significant respiratory viral infection
Who cannot join
- asthma/RAD
- recurrent wheezing
- "recurrent bronchiolitis"
- allergic rhinitis
- atopy
- chronic lung disease
Show all 24Show fewer
- hypertension
- heart failure
- 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
- interstitial lung
Trial locations and contacts
1 site in 1 country.
United States1 site
Winthrop University Hospital
Mineola, New York, 11501
About this study
Official title: A Prospective, Pilot 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
The fraction of exhaled nitric oxide (feNO) in expired air is a reliable measure of airway inflammation. Some research experiments have demonstrated stimulation of nitric oxide production in respiratory epithelial cells infected with RSV.
The principal aims are to determine if the fraction of exhaled nitric oxide (feNO) is elevated in hospitalized pediatric patients with viral lower respiratory illness and to determine if there is a difference in feNO level between RSV and non-RSV infection.
Read more
NO may play a role in the association between RSV, airway reactivity, and airway inflammation.
This is a prospective, pilot study that will noninvasively measure feNO in children 0-4 years of age admitted to Winthrop University Hospital, as well as controls (children in the same age range without respiratory conditions and who are well enough to perform the test). Hospitalized children will be tested for RSV (enzyme immunoassay (EIA) \& DFA) and via direct fluorescent antigen technique (DFA) for influenza A \& B, parainfluenza, human metapneumovirus and adenovirus.
Method of feNO measurement will utilize 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 Offline exhaled air can be collected via a mouthpiece or a face mask connected to a non-re-breathing valve that allows inspiration of NO-free air from an NO-inert reservoir to avoid contamination by ambient NO. Exhaled breath samples are collected into an NO-inert bag fitted with the expiratory port once a stable breathing pattern is present.
The results of all 3 groups will be compared: control, RSV positive and RSV negative samples.
- Conditions
- RSV Infection, Bronchiolitis
- Being tested
- Collection of exhaled breath
- Medical subject headings
- Respiratory Syncytial Virus Infections, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of exhaled breathOther
balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement
| Study group | Role | What they receive |
|---|---|---|
| RSV positive subjects | Subjects admitted to the hospital with Lower respiratory tract Viral infection symptoms from which nasopharyngeal mucous samples are positive for RSV by Direct Fluorescent Antibody technique and/or viral culture Receives: Other: Collection of exhaled breath | |
| RSV negative subjects | Subjects admitted to the hospital with Lower respiratory tract Viral infection symptoms from which nasopharyngeal mucous samples are negative for RSV by Direct Fluorescent Antibody technique and/or viral culture (usually positive for influenza A \& B, parainfluenza, human metapneumovirus or adenovirus) Receives: Other: Collection of exhaled breath | |
| Control group | Children with same age range, ethnic background, and gender distribution as the study group coming for evaluation in the outpatient setting without evidence of viral infection Receives: Other: Collection of exhaled breath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in feNO level between RSV and non-RSV infection in hospitalized pediatric patients with viral lower respiratory illness as well as with control subjects
Measured: 2 years
Secondary outcomes (2)
FeNO levels correlate with the severity of respiratory symptoms in children with acute viral respiratory illness
Measured: 2 years
FeNO levels in viral respiratory illness will vary with steroid use
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startOct 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for RSV InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Winthrop University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Maria L Quintos-Alagheband, MD, Principal investigator, Winthrop University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090557
- Sponsor's protocol ID
- 07029
- Status last verified
- Mar 2010
- First submitted
- 6 Oct 2009
- Last updated
- 22 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
PubMed 15817806Baraldi E, de Jongste JC; European Respiratory Society/American Thoracic Society (ERS/ATS) Task Force. Measurement of exhaled nitric oxide in children, 2001. Eur Respir J. 2002 Jul;20(1):223-37. doi: 10.1183/09031936.02.00293102.
PubMed 12166573Gentile DA, Doyle WJ, Belenky S, Ranck H, Angelini B, Skoner DP. Nasal and oral nitric oxide levels during experimental respiratory syncytial virus infection of adults. Acta Otolaryngol. 2002 Jan;122(1):61-6. doi: 10.1080/00016480252775751.
PubMed 11876601Ricciardolo FL, Sterk PJ, Gaston B, Folkerts G. Nitric oxide in health and disease of the respiratory system. Physiol Rev. 2004 Jul;84(3):731-65. doi: 10.1152/physrev.00034.2003.
PubMed 15269335Kao YJ, Piedra PA, Larsen GL, Colasurdo GN. Induction and regulation of nitric oxide synthase in airway epithelial cells by respiratory syncytial virus. Am J Respir Crit Care Med. 2001 Feb;163(2):532-9. doi: 10.1164/ajrccm.163.2.9912068.
PubMed 11179135Baraldi E, Dario C, Ongaro R, Scollo M, Azzolin NM, Panza N, Paganini N, Zacchello F. Exhaled nitric oxide concentrations during treatment of wheezing exacerbation in infants and young children. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1284-8. doi: 10.1164/ajrccm.159.4.9807084.
PubMed 10194178
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Pilot 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
- ClinicalTrials.gov ID
- NCT01090557
- Acronym / sponsor ID
- 07029
- Conditions
- RSV Infection, Bronchiolitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Winthrop University HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The fraction of exhaled nitric oxide (feNO) in expired air is a reliable measure of airway inflammation. Some research experiments have demonstrated stimulation of nitric oxide production in respiratory epithelial cells infected with RSV.
The principal aims are to determine if the fraction of exhaled nitric oxide (feNO) is elevated in hospitalized pediatric patients with viral lower respiratory illness and to determine if there is a difference in feNO level between RSV and non-RSV infection.
NO may play a role in the association between RSV, airway reactivity, and airway inflammation.
This is a prospective, pilot study that will noninvasively measure feNO in children 0-4 years of age admitted to Winthrop University Hospital, as well as controls (children in the same age range without respiratory conditions and who are well enough to perform the test). Hospitalized children will be tested for RSV (enzyme immunoassay (EIA) \& DFA) and via direct fluorescent antigen technique (DFA) for influenza A \& B, parainfluenza, human metapneumovirus and adenovirus.
Method of feNO measurement will utilize 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 Offline exhaled air can be collected via a mouthpiece or a face mask connected to a non-re-breathing valve that allows inspiration of NO-free air from an NO-inert reservoir to avoid contamination by ambient NO. Exhaled breath samples are collected into an NO-inert bag fitted with the expiratory port once a stable breathing pattern is present.
The results of all 3 groups will be compared: control, RSV positive and RSV negative samples.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RSV positive subjects | – | Other: Collection of exhaled breathSubjects admitted to the hospital with Lower respiratory tract Viral infection symptoms from which nasopharyngeal mucous samples are positive for RSV by Direct Fluorescent Antibody technique and/or viral culture |
| RSV negative subjects | – | Other: Collection of exhaled breathSubjects admitted to the hospital with Lower respiratory tract Viral infection symptoms from which nasopharyngeal mucous samples are negative for RSV by Direct Fluorescent Antibody technique and/or viral culture (usually positive for influenza A \& B, parainfluenza, human metapneumovirus or adenovirus) |
| Control group | – | Other: Collection of exhaled breathChildren with same age range, ethnic background, and gender distribution as the study group coming for evaluation in the outpatient setting without evidence of viral infection |
Who may qualify
- Ages
- 1 day to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The parents of children admitted to WUH with a diagnosis of lower respiratory tract viral illness (LRTVI) will be offered the opportunity to participate
Key inclusion criteria (1 listed)
- Admitted subjects with diagnosis of bronchiolitis, viral pneumonia or other significant respiratory viral infection
Key exclusion criteria (24 listed)
- asthma/RAD
- recurrent wheezing
- "recurrent bronchiolitis"
- allergic rhinitis
- atopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of exhaled breathballoon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement | Other | Control group, RSV negative subjects, RSV positive subjects |
Primary outcome
Difference in feNO level between RSV and non-RSV infection in hospitalized pediatric patients with viral lower respiratory illness as well as with control subjects
Time frame: 2 years
2 secondary outcomes
FeNO levels correlate with the severity of respiratory symptoms in children with acute viral respiratory illness
Time frame: 2 years
FeNO levels in viral respiratory illness will vary with steroid use
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2010.
- Background: PubMed 15817806American Thoracic Society; European Respiratory Society. ATS/ERS recommendations for standardized procedures for the online and offline measurement of exhaled lower respiratory nitric oxide and nasal nitric oxide, 2005. Am J Respir Crit Care Med. 2005 Apr 15;171(8):912-30. doi: 10.1164/rccm.200406-710ST. No abstract available.
- Background: PubMed 12166573Baraldi E, de Jongste JC; European Respiratory Society/American Thoracic Society (ERS/ATS) Task Force. Measurement of exhaled nitric oxide in children, 2001. Eur Respir J. 2002 Jul;20(1):223-37. doi: 10.1183/09031936.02.00293102.
- Background: PubMed 11876601Gentile DA, Doyle WJ, Belenky S, Ranck H, Angelini B, Skoner DP. Nasal and oral nitric oxide levels during experimental respiratory syncytial virus infection of adults. Acta Otolaryngol. 2002 Jan;122(1):61-6. doi: 10.1080/00016480252775751.
- Background: PubMed 15269335Ricciardolo FL, Sterk PJ, Gaston B, Folkerts G. Nitric oxide in health and disease of the respiratory system. Physiol Rev. 2004 Jul;84(3):731-65. doi: 10.1152/physrev.00034.2003.
- Background: PubMed 11179135Kao YJ, Piedra PA, Larsen GL, Colasurdo GN. Induction and regulation of nitric oxide synthase in airway epithelial cells by respiratory syncytial virus. Am J Respir Crit Care Med. 2001 Feb;163(2):532-9. doi: 10.1164/ajrccm.163.2.9912068.
- Background: PubMed 10194178Baraldi E, Dario C, Ongaro R, Scollo M, Azzolin NM, Panza N, Paganini N, Zacchello F. Exhaled nitric oxide concentrations during treatment of wheezing exacerbation in infants and young children. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1284-8. doi: 10.1164/ajrccm.159.4.9807084.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria L Quintos-Alagheband, MD principal investigator
Winthrop University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of RSV Infection and Bronchiolitis, run by Winthrop University Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in feNO level between RSV and non-RSV infection in hospitalized pediatric patients with viral lower respiratory illness as well as with control subjects (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090557, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2010.