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

University of Rochester1 site in 1 country165 target enrollmentFebruary 2007

ConditionsRespiratory Illness

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Respiratory Illness
Sponsor: University of Rochester
Enrollment: 165
Locations: 1
Primary Endpoint: Infants Living in Smoke-free Environments.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2007

End Date

June 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Rochester

Responsible Party

Principal Investigator

Jill Halterman

Associate Professor

University of Rochester

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

Outcomes

Primary Outcomes

Infants Living in Smoke-free Environments.

Time Frame: 5 months post baseline

Infants living in homes with a "home smoking ban" rule

Secondary Outcomes

Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses.(2, 5, and 7-9 months post baseline)