Reducing Environmental Tobacco Smoke in Neonatal Intensive Care Unit (NICU) Infants' Homes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00670280|
Recruitment Status : Completed
First Posted : May 1, 2008
Last Update Posted : January 6, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Infant Environmental Tobacco Smoke Exposure||Behavioral: Motivational Interviewing intervention Behavioral: Usual Care Behavioral: Usual Care - Reduced Measurement||Not Applicable|
Approximately 38% of children aged 2 months to 5 years are exposed to environmental tobacco smoke (ETS), and compelling evidence suggests rates are even higher in low-income, less educated households. The adverse health effects of chronic ETS in children are well documented and include higher risks of delayed lung development, respiratory illnesses, wheeze, cough, asthma, middle ear disease and sudden infant death syndrome. Preterm infants admitted to a Neonatal Intensive Care Unit (NICU) are particularly vulnerable to the effects of ETS, typically exhibiting significant respiratory or chronic lung conditions prior to discharge.
The primary aim of this investigation is to develop and verify the feasibility and efficacy of a multicomponent behavioral intervention for reducing ETS exposure in a low-income, multi-ethnic population of NICU infants at particularly high social and medical risk for adverse effects of ETS. A randomized, controlled, between groups design will be used to test a hospital-based ETS reduction program based on motivational interviewing (MI). A total of 150 families with an infant at high respiratory risk in the NICU who report regular household smoking will be randomized to either MI or Usual Care. The MI intervention will include 2 one-hour counseling sessions within the 2 weeks prior to infant discharge and one telephone counseling call at two weeks post-discharge. Counseling and interviews will be conducted in Spanish or English.
The proposed research brings together highly experienced behavioral and clinical investigators, an extraordinary infrastructure, and a large population easily accessible for intervention prior to discharge. Effective brief, hospital-based interventions to reduce ETS exposure in households with NICU infants at high respiratory risk could result in substantial decreases in adverse health effects and the very large associated costs.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Reducing Environmental Tobacco Smoke in NICU Infants' Homes|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Experimental: Intervention Group
Those randomized to the Intervention group will meet twice over a two-week period with a trained counselor while visiting the neonatal intensive care unit.
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.
Active Comparator: UC Group
Those randomized to the Usual Care group 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
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.
Active Comparator: UC-RM Group
Those randomized to the Usual Care - Reduced Measurement group will receive the same information as the Usual Care group but will be measured less often (only at 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.
- Primary efficacy variables will include both objective (household air nicotine levels; infant ETCO levels) and self-report measures of household ETS exposure. [ Time Frame: 6 months post-intervention ]
- In addition to achieving lower infant smoke exposure rates in the MI condition, we expect MI will produce significant changes in several domains (e.g. self-efficacy, motivation to change). [ Time Frame: 1 month, 3 months, and 6 months post-intervention ]
- Additional preliminary clinical outcomes will be assessed for the generation of evidence-based hypotheses, including differential impact on respiratory symptoms and diagnoses. [ Time Frame: 1 month, 3 months, and 6 months post-intervention ]
- Additional preliminary clinical outcomes will be assessed for the generation of evidence-based hypotheses, including differential impact on healthcare utilization. [ Time Frame: 1 month, 3 months, and 6 months post-intervention ]
- Finally, the impact on ETS outcomes of having an infant with Bronchopulmonary Dysplasia will be explored. [ Time Frame: 1 month, 3 months, and 6 months post-intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670280
|United States, Texas|
|Children's Memorial Hermann Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Angela L Stotts, Ph.D.||The University of Texas Health Science Center, Houston|