NICU Asthma Education and Secondhand Smoke Reduction Study

University of Rochester

Status: Completed

Conditions: Respiratory Illness

Treatments: Behavioral: Asthma Education; Behavioral: Secondhand Smoke Reduction and Smoking Cessation Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT00499915

15214

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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165 participants in 2 patient groups

Secondhand Smoke Reduction and Asthma Education

Experimental group

Description:

Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program.

Treatment:

Behavioral: Asthma Education

Behavioral: Secondhand Smoke Reduction and Smoking Cessation Counseling

Asthma Education

Active Comparator group

Description:

Parents of children in the active comparator group will receive asthma education at NICU discharge.

Treatment:

Behavioral: Asthma Education