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Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases (COOX)

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ClinicalTrials.gov Identifier: NCT02831348
Recruitment Status : Recruiting
First Posted : July 13, 2016
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan M. Gaffin, Boston Children’s Hospital

Brief Summary:
This is a pilot cross-sectional study of measured transcutaneous CO-oximetry in children with inflammatory and non-inflammatory conditions.

Condition or disease
Asthma Allergic Rhinitis Cystic Fibrosis Pneumonia

Detailed Description:

Children and young adults age 6-24 with the following conditions: asthma, pneumonia, allergic rhinitis, cystic fibrosis, and well child (without inflammatory illness) will be recruited.

Subjects will be asked to complete a brief screening survey to determine if they meet inclusion criteria. Enrolled subjects will be asked to complete questionnaire forms to characterize their health, current symptoms, medications, and common exposures. Transcutaneous carboxyhemoglobin will be recorded.

This study is cross-sectional and will only require one visit coinciding with the clinical visit. Analysis will determine the pairwise differences in SpCO between conditions tested.


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Study Type : Observational
Estimated Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Association of Transcutaneous Pulse CO-oximetry With Inflammatory Lung Diseases
Actual Study Start Date : October 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Uncontrolled asthma
Indicated by an asthma control test (ACT) score of <20 and asthma symptoms of cough, wheeze, or chest tightness for more than 2 days in the prior 2 weeks, OR current asthma exacerbation indicated by the prescription of a short course (3-5 days) of systemic corticosteroids by treating provider at the time of visit.
Controlled asthma
Indicated by an ACT score of >19, or spirometry results within 10% of year's best value (based on FEV1).
Pneumonia
Indicated by an admission diagnosis of pneumonia with chest X-ray consistent with the diagnosis, based on attending radiologist's interpretation.
Controlled allergic rhinitis
Indicated by a rhinitis control assessment test (RCAT) score of >= 21.
Uncontrolled allergic rhinitis
Indicated by an RCAT score of <21.
Cystic fibrosis (exacerbated)
Indicated by treating physician's assessment of cystic fibrosis respiratory exacerbation within 24 hours of initial antibiotic therapy.
Cystic fibrosis (stable)
Indicated by diagnosis of cystic fibrosis with baseline symptoms and with spirometry results (based on FEV1) within 5% of year's best value.
Control
Indicated by a negative history of any of the conditions characterizing the other groups.



Primary Outcome Measures :
  1. SpCO comparison: uncontrolled asthma v. other groups [ Time Frame: Time of visit ]
    A pairwise comparison of mean SpCO will be performed between asthma exacerbation group and each other group, e.g., asthma exacerbation v. stable asthma, asthma exacerbation v. pneumonia, etc. An independent t-test will be used to determine statistical significance of the difference of means.



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Ages Eligible for Study:   6 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Age range 6-24years old. All genders, races, and ethnicities were sampled, provided they could complete the study requirements.
Criteria

Inclusion Criteria:

  • diagnosis of asthma, pneumonia, allergic rhinitis, or none of the previous (control group)
  • Ability to complete study procedures

Exclusion Criteria:

  • Cardiopulmonary disease outside of the specific conditions for inclusion
  • Prematurity
  • Congenital heart disease
  • Current diagnosis of more than one of the following: asthma, pneumonia, allergic rhinitis, cystic fibrosis, or - for controls - any current infection
  • Recent serious bacterial infection (except for pneumonia in the pneumonia group)
  • Concurrent clinical chest X-ray with findings other those that expected for the group (i.e. normal chest X-ray in pneumonia group or suspected pneumonia on chest X-ray in asthma group). To be determined by attending radiologist's interpretation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831348


Contacts
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Contact: Jonathan M Gaffin, MD, MMSc 857-218-5379 ext 4768 jonathan.gaffin@childrens.harvard.edu

Locations
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United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Jonathan M Gaffin, MD, MMSc         
Sponsors and Collaborators
Boston Children’s Hospital

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Responsible Party: Jonathan M. Gaffin, Principal Investigator, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT02831348     History of Changes
Other Study ID Numbers: ChildrenH
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jonathan M. Gaffin, Boston Children’s Hospital:
Asthma
Allergic rhinitis
Rhinitis
Pneumonia
Cystic fibrosis

Additional relevant MeSH terms:
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Fibrosis
Pneumonia
Cystic Fibrosis
Rhinitis
Lung Diseases
Rhinitis, Allergic
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases