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OpenTrials
Completed

NCT Number: NCT00499915

NICU Asthma Education and Secondhand Smoke Reduction Study

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.

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Key information

Conditions

Respiratory Illness

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Asthma education

Behavioral

Asthma education will be provided at NICU discharge.

Primary outcomes

  1. Infants Living in Smoke-free Environments.

    Time frame: 5 months post baseline

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Halcyon Hill Foundation

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2015
Study completion
2015
First posted
Jul 12, 2007
Registry last updated
Nov 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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