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| Name | Class |
|---|---|
| Halcyon Hill Foundation | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secondhand Smoke Reduction and Asthma Education | Experimental | Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program. |
|
| Asthma Education | Active Comparator | Parents of children in the active comparator group will receive asthma education at NICU discharge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secondhand Smoke Reduction and Smoking Cessation Counseling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Infants Living in Smoke-free Environments. | Infants living in homes with a "home smoking ban" rule | 5 months post baseline |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill S. Halterman, MD, MPH | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program. Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels. |
| FG001 | Comparison | Parents of children in the active comparator group will receive asthma education at NICU discharge. Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program. Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Gestational Age (weeks) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infants Living in Smoke-free Environments. | Infants living in homes with a "home smoking ban" rule | Posted | Number | participants | 5 months post baseline |
|
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Only the infant participants were assessed for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program. Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment | All infants in this study are born premature and at risk for other complications. These children passed away while enrolled in this study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jill Halterman | University of Rochester | 585-275-5798 | jill_halterman@urmc.rochester.edu |
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| Asthma Education | Behavioral | Asthma education will be provided at NICU discharge. |
|
| BG001 | Comparison | Parents of children in the active comparator group will receive asthma education at NICU discharge. Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| Weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses. | Not Posted | 2, 5, and 7-9 months post baseline |
| 1 |
| 83 |
| 0 |
| 83 |
| EG001 | Comparison | Parents of children in the active comparator group will receive asthma education at NICU discharge. Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented. | 1 | 82 | 0 | 82 |
|
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