NICU Asthma Education and Secondhand Smoke Reduction Study

Study Overview
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Brief Summary
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Premature infants have a significantly increased risk for developing respiratory illnesses and asthma. Secondhand smoke (SHS) also is clearly associated with increased breathing problems in children, thus exposure to smoke makes it substantially more likely for a premature infant to develop wheezing. The overall goal of this study is to test whether comprehensive asthma education combined with a home-based secondhand smoke reduction program can reduce exposure to smoke and prevent respiratory illness among premature infants. Our hypotheses are: More premature infants whose families receive asthma education combined with a SHS reduction intervention will live in smoke-free environments compared to infants receiving only asthma education (control group). Caregivers receiving the SHS reduction program will have higher rates of quit attempts and less relapse into smoking compared to caregivers in the control group. Infants whose families receive the combined intervention will experience less respiratory illness compared to infants in the control group.

Official Title
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Preventing Respiratory Illness Among Premature Infants: An Asthma Education and Secondhand Smoke Reduction Study

Conditions
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Respiratory Illness

Intervention / Treatment
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* Behavioral: Secondhand Smoke Reduction and Smoking Cessation Counseling
* Behavioral: Asthma Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≤32 weeks gestation Planned discharge to home from the Neonatal Intensive Care Unit Parent or caregiver must consent to the intervention The first sibling discharged, for twins or infants from a multiple birth pregnancy Exclusion Criteria: Inability to speak and understand English No access to a working phone for follow-up surveys (either at the subject's home or an easily accessible alternate home) Family residence outside the greater Rochester area (more than 30 miles away) Children in foster care or other situations in which guardian consent cannot be obtained The child having significant medical conditions, including serious heart disease, cystic fibrosis, or other conditions that could interfere with the assessment of respiratory-related outcome measures
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Secondhand Smoke Reduction and Asthma Education<br>Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program. | Behavioral: Secondhand Smoke Reduction and Smoking Cessation Counseling<br>* A secondhand smoke reduction program, including smoking cessation counseling (if appropriate), and feedback about the children's cotinine levels will be implemented using principles of Motivational Interviewing.<br>Behavioral: Asthma Education<br>* Asthma education will be provided at NICU discharge.<br>|
| Active Comparator: Asthma Education<br>Parents of children in the active comparator group will receive asthma education at NICU discharge. | Behavioral: Asthma Education<br>* Asthma education will be provided at NICU discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infants Living in Smoke-free Environments. | Infants living in homes with a home smoking ban rule | 5 months post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses. |  | 2, 5, and 7-9 months post baseline |