Respiratory Illness
Conditions
Brief summary
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.
Interventions
BEHAVIORALAsthma Education
Asthma education will be provided at NICU discharge.
BEHAVIORALSecondhand Smoke Reduction and Smoking Cessation Counseling
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.
Sponsors
Halcyon Hill Foundation
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infants Living in Smoke-free Environments. | 5 months post baseline | Infants living in homes with a home smoking ban rule |
Secondary
| Measure | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 83 |
| 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. | 82 |
| Total | 165 |
Baseline characteristics
| Characteristic | Treatment | Comparison | Total |
|---|---|---|---|
| Age, Continuous | 28.7 Weeks STANDARD_DEVIATION 2.4 | 28.1 Weeks STANDARD_DEVIATION 2.5 | 28.4 Weeks STANDARD_DEVIATION 2.5 |
| Region of Enrollment United States | 83 participants | 82 participants | 165 participants |
| Sex: Female, Male Female | 34 Participants | 33 Participants | 67 Participants |
| Sex: Female, Male Male | 49 Participants | 49 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 83 | 0 / 82 |
| serious Total, serious adverse events | 1 / 83 | 1 / 82 |
Outcome results
Primary
Infants Living in Smoke-free Environments.
Infants living in homes with a home smoking ban rule
Time frame: 5 months post baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | Infants Living in Smoke-free Environments. | 65 participants |
| Comparison | Infants Living in Smoke-free Environments. | 64 participants |
Secondary
Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses.
Time frame: 2, 5, and 7-9 months post baseline