An observational study in Smoking, sponsored by University of Florida. Completed at 2 sites in United States. Open to participants aged 6 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-12-28.
Sponsored by University of Florida · Observational
Electronic cigarette use may be less harmful than cigarettes in adults, however, limited data exists examining passive electronic cigarette exposure and child health outcomes. The current study seeks to compare health-related outcomes among youth who reside with non-smokers, cigarette smokers, and electronic cigarette users. The investigators propose to conduct a small pilot study with 30 youth, ages 6-17 and a caregiver. Three groups of 10 parent-child dyads will be recruited: 1) control group: parents who are non-smokers/non-vapers, 2) smoking group: parents who are exclusive cigarette smokers, and 3) vaping group: parents who are exclusively ECIG users. Groups will be compared across the following variables: child lung function and biomarkers of nicotine.
The current study seeks to compare health-related outcomes among youth who reside with non-smokers, cigarette smokers, and electronic cigarette users.
Control Group: will consist of participants ages 6 - 17 who live in a home with adults who do not smoke. A brief breathing test will verify a non-smoker and/or are not around a certain amount of smoke in the environment (live with a smoker). The participant will be asked to complete a series of brief questionnaires that asks about basic demographic information, medical history, and that asks about their smoking history. The participant's will also be asked to complete two 5 minute breathing tests, provide a sample of saliva, a urine sample, and have their toe nails clipped.
Vaping Group: will consist of participants ages 6 -17 who live in a home with adults who currently use electronic cigarettes. A brief breathing test will verify a non-tobacco smoker and/or are not around a certain amount of smoke in the environment (live with a tobacco smoker). The participant will be asked to complete a series of brief questionnaires that asks about basic demographic information, smoking or vaping history and patterns of use, and medical history. The participant will be asked to complete two 5 minute breathing tests, provide a sample of saliva, a urine sample, and have their toe nails clipped.
Smoking Group: will consist of participants ages 6 - 17 who live in a home with adults who currently smoke cigarettes. Participants will then be asked to complete a series of brief questionnaires that asks about basic demographic information, smoking or vaping history and patterns of use, and medical history. The participant will also be asked to complete two 5 minute breathing tests, provide a sample of saliva, a urine sample, and have their toe nails clipped.
325 studies on the registry are indexed under Smoking; 141 are open to participants now.
This study's enrollment of 44 is below the median of 114 across 69 observational studies indexed under Smoking.
Browse Smoking studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
In order to be included in the study, parents must: 1) be a legal guardian of a child between the ages of 6-17 (if caregiver has more > 1 child between 6-17 years; 2) be aged 18-65 years; and 3) be fluent in English. Additionally, the child must reside in the same home as the caregiver.
Inclusion Criteria:
For the control group the caregiver must self-report:
For the smoking group caregivers must:
For the vaping group caregivers must:
This group will provide 2 breath carbon monoxide (reading of ≤ 6 parts per million) and a saliva sample, urine sample, and toe nail clippings will be taken from this group.
Other: Saliva sample · Other: Urine Sample · Other: Toe nail clippings · Other: Breath carbon monoxide test
This group will provide 1 breath carbon monoxide test (reading of ≤ 6 parts per million) and a saliva sample, urine sample, and toe nail clippings.
Other: Saliva sample · Other: Urine Sample · Other: Toe nail clippings · Other: Breath carbon monoxide test
This group will provide 2 breath carbon monoxide test (reading of ≤ 6 parts per million) and a saliva sample, urine sample, and toe nail clippings.
Other: Saliva sample · Other: Urine Sample · Other: Toe nail clippings · Other: Breath carbon monoxide test
All participants will provide a saliva sample.
All participants will provide a urine sample.
All participants will provide toe nail clippings.
All participants will provide breath carbon monoxide tests
Assessment of lung function
Child lung function will be measured at the study visit. Forced expiratory volume in the first second will be assessed.
Time frame: Day 1
Assessment of cotinine in saliva
Child saliva samples will be collected at the study visit. Samples will be assessed for cotinine levels.
Time frame: Day 1
Assessment of cotinine in urine
Child urine samples will be collected at the study visit. Samples will be assessed for cotinine levels.
Time frame: Day 1
Assessment of nicotine in toenail clippings
Child toenail samples will collected at the study visit. Samples will be assessed for nicotine levels.
Time frame: Day 1
Assessment of cotinine in toenail clippings
Child toenail samples will be collected at the study visit. Samples will be assessed for cotinine levels.
Time frame: Day 1
Assessment of tobacco specific nitrosamine in toenail clippings
Child toenail samples will be collected at the study visit. Samples will be assessed for NNAL levels.
Time frame: Day 1
Assessment of tobacco specific nitrosamine in urine
Child urine samples will be collected at the study visit. Samples will be assessed for NNAL levels.
Time frame: Day 1
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Nov 2015, a primary completion of Nov 2016 and a completion of Nov 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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