Clinical trial NCT03062709: A Study of Tobacco Smoke and Children With Respiratory Illnesses
Official title: Urine Cotinine in Children and Parental Behavior Modification: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Pneumonia
Reactive Airway Disease
Asthma
Tobacco Smoking
Tobacco Cessation
Bronchopulmonary Dysplasia
Keywords: tobacco cessation
bronchiolitis
pneumonia
pediatric
environmental tobacco smoke
secondhand tobacco smoke
thirdhand tobacco smoke
tobacco smoke
asthma
reactive airway disease
bronchopulmonary dysplasia
Lead sponsor: MaineHealth
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 3
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of acceptance of a smoking cessation intervention
timeFrame: one month for each patient
Secondary outcomes:
measure: Rate of positive urine cotinine in children admitted with positive tobacco smoke exposure history.
timeFrame: 24 hours for each patient
measure: Staff hours required to provide a smoking cessation intervention
timeFrame: one month for each patient
measure: Rate of acceptance of follow-up urine cotinine testing
timeFrame: one month for each patient
Other outcomes:
Locations:
city: Portland
country: United States
facility: The Barbara Bush Children's Hospital at Maine Medical Center
state: Maine
Study officials:
affiliation: MaineHealth
name: Deirdre Burns, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: