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

NCT01098227 | Withdrawn DMC

• 1 other identifier: 147914
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bronchiolitis; Infection; Nitric Oxide

Keywords

RSV Bronchiolitis; Lower Respiratory Viral infection; Exhaled Nitric Oxide

Outcome Measures

Primary Outcomes (2)

• 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

  1 year

• 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

  1 year

Study Arms (3)

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 Criteria

• Age: Up to 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

• Consecutive children admitted to WUH with a diagnosis of bronchiolitis, viral pneumonia or other significant respiratory viral infection

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Winthrop University Hospital

Mineola, New York, 11501, United States

Location

Related Publications (11)

• Baraldi 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.

  PMID: 12166573 BACKGROUND

• Ricciardolo 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.

  PMID: 15269335 BACKGROUND

• Kao 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.

  PMID: 11179135 BACKGROUND

• Beilman G. Exhaled nitric oxide in pathophysiologic states: the substance behind the gas. Chest. 2004 Jan;125(1):11-3. doi: 10.1378/chest.125.1.11. No abstract available.

  PMID: 14718413 BACKGROUND

• Baraldi 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.

  PMID: 10194178 BACKGROUND

• Gabriele C, Nieuwhof EM, Van Der Wiel EC, Hofhuis W, Moll HA, Merkus PJ, De Jongste JC. Exhaled nitric oxide differentiates airway diseases in the first two years of life. Pediatr Res. 2006 Oct;60(4):461-5. doi: 10.1203/01.pdr.0000238242.39881.64. Epub 2006 Aug 28.

  PMID: 16940253 BACKGROUND

• Baraldi E, Ghiro L, Piovan V, Carraro S, Ciabattoni G, Barnes PJ, Montuschi P. Increased exhaled 8-isoprostane in childhood asthma. Chest. 2003 Jul;124(1):25-31. doi: 10.1378/chest.124.1.25.

  PMID: 12853498 BACKGROUND

• Jartti T, Makela MJ, Vanto T, Ruuskanen O. The link between bronchiolitis and asthma. Infect Dis Clin North Am. 2005 Sep;19(3):667-89. doi: 10.1016/j.idc.2005.05.010.

  PMID: 16102655 BACKGROUND

• Mansbach JM, Camargo CA Jr. Respiratory viruses in bronchiolitis and their link to recurrent wheezing and asthma. Clin Lab Med. 2009 Dec;29(4):741-55. doi: 10.1016/j.cll.2009.07.011.

  PMID: 19892232 BACKGROUND

• Sigurs N, Bjarnason R, Sigurbergsson F, Kjellman B. Respiratory syncytial virus bronchiolitis in infancy is an important risk factor for asthma and allergy at age 7. Am J Respir Crit Care Med. 2000 May;161(5):1501-7. doi: 10.1164/ajrccm.161.5.9906076.

  PMID: 10806145 BACKGROUND

• 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.

  PMID: 15817806 BACKGROUND

Biospecimen

Retention: NONE RETAINED

Exhaled air for Nitric Oxide measurement

MeSH Terms

Conditions

Bronchiolitis; Infections

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Maria L Quintos-Alagheband, MD

  Winthrop University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: April 2, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 16, 2020

Record last verified: 2020-03

Locations

US (1)