Reducing Environmental Tobacco Smoke in Neonatal Intensive Care Unit (NICU) Infants' Homes
NCT00670280 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144
Last updated 2016-01-06
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.
Conditions
- Infant Environmental Tobacco Smoke Exposure
Interventions
- BEHAVIORAL
-
Motivational Interviewing intervention
Those randomized to receive the Motivational Interviewing intervention will meet twice over a two-week period with a trained counselor while visiting the neonatal intensive care unit. Each visit will consist of a 45 minute session in which household smoking practices will be assessed and discussed. Two weeks after the child has been discharged from the hospital, the counselor will contact participants via telephone for a third 20-30 minute telephone meeting. After the third contact with the counselor, a letter will be mailed to participants summarizing information covered in the three meetings.
- BEHAVIORAL
-
Usual Care
Those randomized to receive the Usual Care intervention will receive written information on secondary smoke and infant health and will be assessed at 1 month, 3 months, and 6 months post-intervention.
- BEHAVIORAL
-
Usual Care - Reduced Measurement
Those randomized to the Usual Care - Reduced Measurement intervention will receive the same written information on secondary smoke and infant health as the Usual Care intervention but will be assessed only at the 6-month timepoint.
Sponsors & Collaborators
-
HRSA/Maternal and Child Health Bureau
collaborator FED -
The University of Texas Health Science Center, Houston
lead OTHER
Principal Investigators
-
Angela L Stotts, Ph.D. · The University of Texas Health Science Center, Houston
Study Design
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-05-31
- Primary Completion
- 2011-11-30
- Completion
- 2011-11-30
Countries
- United States
Study Locations
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