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NICU Asthma Education and Secondhand Smoke Reduction Study

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ClinicalTrials.gov Identifier: NCT00499915
Recruitment Status : Completed
First Posted : July 12, 2007
Results First Posted : November 23, 2015
Last Update Posted : November 23, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Respiratory Illness Behavioral: Secondhand Smoke Reduction and Smoking Cessation Counseling Behavioral: Asthma Education

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Respiratory Illness Among Premature Infants: An Asthma Education and Secondhand Smoke Reduction Study
Study Start Date : February 2007
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Smoking
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Secondhand Smoke Reduction and Asthma Education
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
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.
Behavioral: Asthma Education
Asthma education will be provided at NICU discharge.
Active Comparator: Asthma Education
Parents of children in the active comparator group will receive asthma education at NICU discharge.
Behavioral: Asthma Education
Asthma education will be provided at NICU discharge.


Outcome Measures

Primary Outcome Measures :
  1. Infants Living in Smoke-free Environments. [ Time Frame: 5 months post baseline ]
    Infants living in homes with a "home smoking ban" rule


Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499915


Locations
United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Halcyon Hill Foundation
Investigators
Principal Investigator: Jill S. Halterman, MD, MPH University of Rochester
More Information

Responsible Party: Jill Halterman, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00499915     History of Changes
Other Study ID Numbers: 15214
First Posted: July 12, 2007    Key Record Dates
Results First Posted: November 23, 2015
Last Update Posted: November 23, 2015
Last Verified: October 2015