BronchiolitisNCT03062709
A Study of Tobacco Smoke and Children With Respiratory Illnesses
A study testing Breathe Easy Coalition written materials, Maine Tobacco Helpline and Urine cotinine testing in people with Bronchiolitis and Pneumonia, run by MaineHealth at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 10 years
- Conditions the study is for
- Bronchiolitis, Pneumonia, Reactive Airway Disease
- What is being tested?
- Breathe Easy Coalition written materials, Maine Tobacco Helpline and Urine cotinine testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2017to 30 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Barbara Bush Children's Hospital at Maine Medical Center
Portland, Maine, 04101
About this study
Official title: Urine Cotinine in Children and Parental Behavior Modification: A Pilot Study
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.
Read the detailed description
Children who are regularly exposed to environmental tobacco smoke (ETS) are at a greater risk for developing respiratory disease. Given the strong relationship between parental smoking and child health, many studies have evaluated the efficacy of interventions to modify parental smoking behavior and thereby reduce children's exposure to second- and thirdhand tobacco smoke, including the use of cotinine levels in children. There are several local ETS exposure intervention programs for The Barbara Bush Children's Hospital patient population and their families. The state of Maine and MaineHealth fund a free 24-hour tobacco cessation hotline (The Maine Tobacco Helpline) which combines evidence-based behavioral counseling techniques and free nicotine replacement therapy (gum, lozenge, or patch). MaineHealth also runs a tobacco cessation campaign (The Breathe Easy Coalition) that provides print materials and trainings aimed to reduce smoking in public housing, hospitals, behavioral health facilities, and higher education. The Breathe Easy Coalition's Smoke-Free Housing program provides education about the effects of secondhand and thirdhand tobacco smoke and asks families to pledge to keep tobacco smoke out of their home. This study aims to combine all three of these strategies (child cotinine feedback, tobacco cessation counseling, and written materials on ETS) to create a cohesive ETS exposure reduction program for the Barbara Bush Children's Hospital inpatient population, and determine the feasibility of a future study that would evaluate whether cotinine testing is helpful for changing smoking behaviors in this target population.
- Conditions
- Bronchiolitis, Pneumonia, Reactive Airway Disease, Asthma, Tobacco Smoking, Tobacco Cessation
- Being tested
- Breathe Easy Coalition written materials, Maine Tobacco Helpline, Urine cotinine testing
- Keywords
- tobacco cessation, bronchiolitis, pneumonia, pediatric, environmental tobacco smoke, secondhand tobacco smoke, thirdhand tobacco smoke, tobacco smoke, asthma, reactive airway disease, bronchopulmonary dysplasia
- Medical subject headings
- Bronchiolitis, Pneumonia, Pulmonary Disease, Chronic Obstructive, Asthma, Tobacco Smoking, Tobacco Use Cessation, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathe Easy Coalition written materialsBehavioural
written materials about secondhand and thirdhand environmental smoke exposure in children
Maine Tobacco HelplineBehavioural
referral to tobacco cessation counselor, helpline calls adult referred to provide counseling over the phone.
Urine cotinine testingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Experimental | 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 Receives: Behavioral: Breathe Easy Coalition written materials; Behavioral: Maine Tobacco Helpline; Diagnostic Test: Urine cotinine testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month for each patient
Secondary outcomes (3)
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.
Measured: 24 hours for each patient
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
Measured: one month for each patient
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.
Measured: one month for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start12 Mar 2017
- Primary completion30 Mar 2017
- Study completion30 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deirdre Burns, MaineHealth
- Investigators
- Deirdre Burns, MD, MPH, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062709
- Sponsor's protocol ID
- 986404-3
- Status last verified
- May 2017
- First submitted
- 20 Feb 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Cotinine in Children and Parental Behavior Modification: A Pilot Study
- ClinicalTrials.gov ID
- NCT03062709
- Acronym / sponsor ID
- 986404-3
- Conditions
- Bronchiolitis, Pneumonia, Reactive Airway Disease, Asthma, Tobacco Smoking, Tobacco Cessation
- Keywords
- tobacco cessation, bronchiolitis, pneumonia, pediatric, environmental tobacco smoke, secondhand tobacco smoke, thirdhand tobacco smoke, tobacco smoke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Study start
- 12 Mar 2017 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Children who are regularly exposed to environmental tobacco smoke (ETS) are at a greater risk for developing respiratory disease. Given the strong relationship between parental smoking and child health, many studies have evaluated the efficacy of interventions to modify parental smoking behavior and thereby reduce children's exposure to second- and thirdhand tobacco smoke, including the use of cotinine levels in children. There are several local ETS exposure intervention programs for The Barbara Bush Children's Hospital patient population and their families. The state of Maine and MaineHealth fund a free 24-hour tobacco cessation hotline (The Maine Tobacco Helpline) which combines evidence-based behavioral counseling techniques and free nicotine replacement therapy (gum, lozenge, or patch). MaineHealth also runs a tobacco cessation campaign (The Breathe Easy Coalition) that provides print materials and trainings aimed to reduce smoking in public housing, hospitals, behavioral health facilities, and higher education. The Breathe Easy Coalition's Smoke-Free Housing program provides education about the effects of secondhand and thirdhand tobacco smoke and asks families to pledge to keep tobacco smoke out of their home. This study aims to combine all three of these strategies (child cotinine feedback, tobacco cessation counseling, and written materials on ETS) to create a cohesive ETS exposure reduction program for the Barbara Bush Children's Hospital inpatient population, and determine the feasibility of a future study that would evaluate whether cotinine testing is helpful for changing smoking behaviors in this target population.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Experimental | Behavioral: Breathe Easy Coalition written materials, Behavioral: Maine Tobacco Helpline, Diagnostic Test: Urine cotinine testingBreathe 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 |
Who may qualify
- Ages
- Up to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathe Easy Coalition written materialswritten materials about secondhand and thirdhand environmental smoke exposure in children | Behavioural | All Participants |
| Maine Tobacco Helplinereferral to tobacco cessation counselor, helpline calls adult referred to provide counseling over the phone. | Behavioural | All Participants |
| Urine cotinine testingthe 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. | Diagnostic test | All Participants |
Primary outcome
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.
3 secondary outcomes
Rate of positive urine cotinine in children admitted with positive tobacco smoke exposure history.
Time frame: 24 hours for each patient
Staff hours required to provide a smoking cessation intervention
Time frame: one month for each patient
Rate of acceptance of follow-up urine cotinine testing
Time frame: one month for each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Breathe Easy CoalitionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deirdre Burns, MD, MPH principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathe Easy Coalition written materials, Maine Tobacco Helpline and Urine cotinine testing in people with Bronchiolitis and Pneumonia, run by MaineHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of acceptance of a smoking cessation intervention (time frame: one month for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2017; AzTrials last refreshed its copy on 8 Nov 2026.