A Study of Tobacco Smoke and Children With Respiratory Illnesses
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03062709|
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : May 16, 2017
|Condition or disease||Intervention/treatment|
|Bronchiolitis Pneumonia Reactive Airway Disease Asthma Tobacco Smoking Tobacco Cessation Bronchopulmonary Dysplasia||Behavioral: Breathe Easy Coalition written materials Behavioral: Maine Tobacco Helpline Diagnostic Test: Urine cotinine testing|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Urine Cotinine in Children and Parental Behavior Modification: A Pilot Study|
|Actual Study Start Date :||March 12, 2017|
|Primary Completion Date :||March 30, 2017|
|Study Completion Date :||April 30, 2017|
Experimental: All Participants
Breathe Easy Coalition written materials provided to parent/guardian, plus Maine Tobacco Helpline referral provided to smoking adult in the home, plus testing of the child's urine cotinine and results reported to parent/guardian
Behavioral: Breathe Easy Coalition written materials
written materials about secondhand and thirdhand environmental smoke exposure in childrenBehavioral: Maine Tobacco Helpline
referral to tobacco cessation counselor, helpline calls adult referred to provide counseling over the phone.Diagnostic Test: Urine cotinine testing
the child's urine is tested for cotinine, which is produced when the body absorbs nicotine. These results are communicated to the child's parent/guardian.
- Rate of acceptance of a smoking cessation intervention [ Time Frame: one month for each patient ]Rate of acceptance of participation in each of the three smoking cessation interventions in this patient population at BBCH--written materials, phone counseling, and urine cotinine testing.
- Rate of positive urine cotinine in children admitted with positive tobacco smoke exposure history. [ Time Frame: 24 hours for each patient ]We will assess the number of children who have a positive smoke exposure history and whose urine is positive for cotinine.
- Staff hours required to provide a smoking cessation intervention [ Time Frame: one month for each patient ]The staff hours required to provide timely consent and sample collection, and the staff hours required to collect data and provide test results
- Rate of acceptance of follow-up urine cotinine testing [ Time Frame: one month for each patient ]Rate of parental acceptance of possible follow-up cotinine testing were it provided in a future study.
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): NCT03062709
|United States, Maine|
|The Barbara Bush Children's Hospital at Maine Medical Center|
|Portland, Maine, United States, 04101|
|Principal Investigator:||Deirdre Burns, MD, MPH||Maine Medical Center|