Reducing Environmental Tobacco Smoke in Neonatal Intensive Care Unit (NICU) Infants' Homes (NCT00670280) | Clinical Trial Compass
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 range
12 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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