N/A
N=165
NICU Asthma Education and Secondhand Smoke Reduction Study
Respiratory Illness
Bottom Line
View on ClinicalTrials.gov: NCT00499915 ↗Enrolled (actual)
165
Serious AEs
1.2%
Results posted
Nov 2015
Primary outcome: Primary: Infants Living in Smoke-free Environments. — 65; 64 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Secondhand Smoke Reduction and Smoking Cessation Counseling (Behavioral); Asthma Education (Behavioral)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Infants Living in Smoke-free Environments. |
65; 64 | — |
| SECONDARY Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses. |
— | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00499915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.