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A Study of Tobacco Smoke and Children With Respiratory Illnesses

Primary Purpose

Bronchiolitis, Pneumonia, Reactive Airway Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breathe Easy Coalition written materials
Maine Tobacco Helpline
Urine cotinine testing
Sponsored by
MaineHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchiolitis focused on measuring tobacco cessation, bronchiolitis, pneumonia, pediatric, environmental tobacco smoke, secondhand tobacco smoke, thirdhand tobacco smoke, tobacco smoke, asthma, reactive airway disease, bronchopulmonary dysplasia

Eligibility Criteria

undefined - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Barbara Bush Children's Hospital at Maine Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Participants

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
February 20, 2017
Last Updated
May 15, 2017
Sponsor
MaineHealth
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1. Study Identification

Unique Protocol Identification Number
NCT03062709
Brief Title
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

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
March 12, 2017 (Actual)
Primary Completion Date
March 30, 2017 (Actual)
Study Completion Date
April 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MaineHealth

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Participants
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Breathe Easy Coalition written materials
Intervention Description
written materials about secondhand and thirdhand environmental smoke exposure in children
Intervention Type
Behavioral
Intervention Name(s)
Maine Tobacco Helpline
Intervention Description
referral to tobacco cessation counselor, helpline calls adult referred to provide counseling over the phone.
Intervention Type
Diagnostic Test
Intervention Name(s)
Urine cotinine testing
Intervention Description
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 Measure Information:
Title
Rate of acceptance of a smoking cessation intervention
Description
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.
Time Frame
one month for each patient
Secondary Outcome Measure Information:
Title
Rate of positive urine cotinine in children admitted with positive tobacco smoke exposure history.
Description
We will assess the number of children who have a positive smoke exposure history and whose urine is positive for cotinine.
Time Frame
24 hours for each patient
Title
Staff hours required to provide a smoking cessation intervention
Description
The staff hours required to provide timely consent and sample collection, and the staff hours required to collect data and provide test results
Time Frame
one month for each patient
Title
Rate of acceptance of follow-up urine cotinine testing
Description
Rate of parental acceptance of possible follow-up cotinine testing were it provided in a future study.
Time Frame
one month for each patient

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deirdre Burns, MD, MPH
Organizational Affiliation
MaineHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Barbara Bush Children's Hospital at Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://breatheeasymaine.org/
Description
Breathe Easy Coalition

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A Study of Tobacco Smoke and Children With Respiratory Illnesses

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