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NICU Asthma Education and Secondhand Smoke Reduction Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Halcyon Hill Foundation
Information provided by (Responsible Party):
Jill Halterman, University of Rochester
ClinicalTrials.gov Identifier:
NCT00499915
First received: July 10, 2007
Last updated: July 23, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention
Respiratory Illness
 Behavioral: Secondhand Smoke Reduction, Smoking Cessation
Behavioral: Asthma Education with Secondhand Smoke Reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Respiratory Illness Among Premature Infants: An Asthma Education and Secondhand Smoke Reduction Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Infants living in smoke-free environments. [ Time Frame: 2, 5, and 7-9 months post baseline ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: February 2007
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.
 Behavioral: 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: 2
Parents of children in the active comparator group will receive asthma education at NICU discharge.
 Behavioral: 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.

  Eligibility

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jill Halterman, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT00499915     History of Changes
Other Study ID Numbers: 15214
Study First Received: July 10, 2007
Last Updated: July 23, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013