NICU Asthma Education and Secondhand Smoke Reduction Study

NCT00499915 | Completed Results

• 1 other identifier: 15214
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Illness

Outcome Measures

Primary Outcomes (1)

• Infants Living in Smoke-free Environments.

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

  5 months post baseline

Secondary Outcomes (1)

• Respiratory Morbidity Assessed Through Respiratory Symptoms as Well as Health Care Utilization for Respiratory Illnesses.

  2, 5, and 7-9 months post baseline

Study Arms (2)

Secondhand Smoke Reduction and Asthma Education

EXPERIMENTAL

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

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

Asthma Education

ACTIVE COMPARATOR

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

Behavioral: Asthma Education

Interventions

Secondhand Smoke Reduction and Smoking Cessation Counseling BEHAVIORAL

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.

Secondhand Smoke Reduction and Asthma Education

Asthma Education BEHAVIORAL

Asthma education will be provided at NICU discharge.

Asthma Education; Secondhand Smoke Reduction and Asthma Education

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Halcyon Hill Foundation: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Results Point of Contact

• Title: Dr. Jill Halterman
• Organization: University of Rochester

jill_halterman@urmc.rochester.edu

585-275-5798

Study Officials

• Jill S. Halterman, MD, MPH

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 10, 2007
• First Posted: July 12, 2007
• Study Start: February 1, 2007
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: November 23, 2015
• Results First Posted: November 23, 2015

Record last verified: 2015-10

Locations

US (1)