A Study of Tobacco Smoke and Children With Respiratory Illnesses

NCT03062709 | Completed

• 1 other identifier: 986404-3
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of positive urine cotinine in children admitted with positive tobacco smoke exposure history.

  24 hours for each patient

• Staff hours required to provide a smoking cessation intervention

  one month for each patient

• Rate of acceptance of follow-up urine cotinine testing

  one month for each patient

Study Arms (1)

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

Behavioral: Breathe Easy Coalition written materials; Behavioral: Maine Tobacco Helpline; Diagnostic Test: Urine cotinine testing

Interventions

Breathe Easy Coalition written materials BEHAVIORAL

written materials about secondhand and thirdhand environmental smoke exposure in children

All Participants

Maine Tobacco Helpline BEHAVIORAL

referral to tobacco cessation counselor, helpline calls adult referred to provide counseling over the phone.

All Participants

Urine cotinine testing DIAGNOSTIC_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.

All Participants

Eligibility Criteria

• Age: Up to 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MaineHealth: lead

Study Sites (1)

The Barbara Bush Children's Hospital at Maine Medical Center

Portland, Maine, 04101, United States

Location

Related Links

• Breathe Easy Coalition

MeSH Terms

Conditions

Bronchiolitis; Pneumonia; Pulmonary Disease, Chronic Obstructive; Asthma; Tobacco Smoking; Tobacco Use Cessation; Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Smoking; Behavior; Tobacco Use; Health Behavior; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Deirdre Burns, MD, MPH

  MaineHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: February 23, 2017
• Study Start: March 12, 2017
• Primary Completion: March 30, 2017
• Study Completion: April 30, 2017
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)