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. Identifier: NCT03062709
Recruitment Status : Completed
First Posted : February 23, 2017
Last Update Posted : May 16, 2017
Information provided by (Responsible Party):
Deirdre Burns, Maine Medical Center

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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Urine Cotinine in Children and Parental Behavior Modification: A Pilot Study
Actual Study Start Date : March 12, 2017
Actual Primary Completion Date : March 30, 2017
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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 children

Behavioral: 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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   up to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03062709

United States, Maine
The Barbara Bush Children's Hospital at Maine Medical Center
Portland, Maine, United States, 04101
Sponsors and Collaborators
Maine Medical Center
Principal Investigator: Deirdre Burns, MD, MPH Maine Medical Center

Additional Information:
Responsible Party: Deirdre Burns, Principal Investigator, Maine Medical Center Identifier: NCT03062709     History of Changes
Other Study ID Numbers: 986404-3
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Deirdre Burns, Maine Medical Center:
tobacco cessation
environmental tobacco smoke
secondhand tobacco smoke
thirdhand tobacco smoke
tobacco smoke
reactive airway disease
bronchopulmonary dysplasia

Additional relevant MeSH terms:
Bronchopulmonary Dysplasia
Bronchial Hyperreactivity
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bronchial Diseases
Lung Diseases, Obstructive
Ventilator-Induced Lung Injury
Lung Injury
Infant, Premature, Diseases
Infant, Newborn, Diseases