Asthma Clinical Trial
Official title:
Urine Cotinine in Children and Parental Behavior Modification: A Pilot Study
Verified date | May 2017 |
Source | Maine Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to assess the feasibility of using an intervention for environmental smoke exposure in children that uses cotinine testing results with written materials and telephone counseling for a potential future study of parents whose children are admitted with respiratory illnesses to The Barbara Bush Children's Hospital in Portland, Maine.
Status | Completed |
Enrollment | 3 |
Est. completion date | April 30, 2017 |
Est. primary completion date | March 30, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 10 Years |
Eligibility |
Inclusion Criteria: - age 0 to 10 years old - admitted to The Barbara Bush Children Hospital for bronchiolitis, pneumonia, bronchopulmonary dysplasia, or asthma - the child lives with an adult who smokes cigarettes Exclusion Criteria: - Non-English-speaking and -reading adults will be excluded as our interventions are in English. - Children over the age of 10 will be excluded as we wanted to avoid children who themselves smoke, given that we will not have a confidential way to assess this. - Breastfeeding children will be excluded as nicotine is transferrable in breast milk. - Families (meaning the parent or guardian, the child, and any smoking coinhabiting caregiver) will be excluded if the parent or the smoking adult is a minor, as they would not be able to give consent for participation. - Children in foster care or whose guardian is the state will be excluded as we are unlikely to achieve timely consent. - Families who do not reside in Maine will be excluded as The Maine Tobacco Helpline is not able to provide services for out-of-state residents. - Children readmitted to the hospital during our study period will be excluded if they have already participated in this study during a previous admission. |
Country | Name | City | State |
---|---|---|---|
United States | The Barbara Bush Children's Hospital at Maine Medical Center | Portland | Maine |
Lead Sponsor | Collaborator |
---|---|
Maine Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of acceptance of a smoking cessation intervention | 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. | one month for each patient | |
Secondary | Rate of positive urine cotinine in children admitted with positive tobacco smoke exposure history. | We will assess the number of children who have a positive smoke exposure history and whose urine is positive for cotinine. | 24 hours for each patient | |
Secondary | Staff hours required to provide a smoking cessation intervention | The staff hours required to provide timely consent and sample collection, and the staff hours required to collect data and provide test results | one month for each patient | |
Secondary | Rate of acceptance of follow-up urine cotinine testing | Rate of parental acceptance of possible follow-up cotinine testing were it provided in a future study. | one month for each patient |
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