CompletedNot Applicable

Reducing Environmental Tobacco Smoke in Neonatal Intensive Care Unit (NICU) Infants' Homes

United States144 participantsStarted 2008-05

Plain-language summary

This study is about reducing the risks of smoke-related infant health problems. Research has shown that infants exposed to secondary smoke have higher risks of delayed lung development, respiratory illnesses, wheeze, cough, asthma, middle ear disease, and sudden infant death syndrome. Infants who have experienced low birth weight or required mechanical ventilation may be at an even greater risk for the negative effects of smoking. The purpose of this study is to evaluate the effectiveness of a 3-session program aimed at assisting the primary care giver in reducing risks to their child's health by decreasing infant smoke exposure in their home and/or reducing overall cigarette use. Caregivers will not be required to quit smoking to take part in this program. This information will, in the future, help to identify and improve ways of reducing health problems and perhaps death in children.

Who can participate

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * have an infant that is 2-3 weeks prior to the estimated date of hospital discharge in the NICU at Children's Memorial Hermann Hospital * have an infant at high respiratory risk (very low birth weight or received mechanical ventilation for \>12 hours) * report at least one person in the home who usually smokes \>6 cigarettes/week in the house * speak English or Spanish * agree to the assessments * attend intervention sessions (anyone who smokes in the home would be asked but not required to attend) * live within 50 miles of our center * have access to a telephone * provide informed consent Exclusion Criteria: * severe cognitive, and/or psychiatric impairment, per judgment of NICU and research staff, that precludes cooperation with study protocol * inability to read, write, speak English or Spanish * inability or unwillingness to provide signed consent for participation, including parental consent if under age 18 (unless caregiver is an emancipated minor) * inability or unwillingness to meet study requirements, including follow-up home visits for data collection purposes

What they're measuring

Primary efficacy variables will include both objective (household air nicotine levels; infant ETCO levels) and self-report measures of household ETS exposure.

Timeframe: 6 months post-intervention

Trial details

NCT IDNCT00670280

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-11