Overview

This trial is active, not recruiting.

Condition respiratory illness
Treatments secondhand smoke reduction, smoking cessation, asthma education with secondhand smoke reduction
Sponsor University of Rochester
Collaborator Halcyon Hill Foundation
Start date February 2007
End date June 2015
Trial size 165 participants
Trial identifier NCT00499915, 15214

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
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.
(Active Comparator)
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.

Primary Outcomes

Measure
Infants living in smoke-free environments.
time frame: 2, 5, and 7-9 months post baseline

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Preventing Respiratory Illness Among Premature Infants: An Asthma Education and Secondhand Smoke Reduction Study
Principal investigator Jill S. Halterman, MD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by University of Rochester.