Clinical trial NCT00670280: Reducing Environmental Tobacco Smoke in Neonatal Intensive Care Unit (NICU) Infants' Homes
Official title: Reducing Environmental Tobacco Smoke in NICU Infants' Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Environmental Tobacco Smoke Exposure
Keywords: Neonatal Intensive Care Units
Infant Morbidity
Low Birth Weight
Low Income Populations
MCH Research
Respiratory Illnesses
Substance Exposed Infants
Counseling
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2008-05-01
Enrollment: 144
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
Secondary outcomes:
measure: 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).
timeFrame: 1 month, 3 months, and 6 months post-intervention
measure: Additional preliminary clinical outcomes will be assessed for the generation of evidence-based hypotheses, including differential impact on respiratory symptoms and diagnoses.
timeFrame: 1 month, 3 months, and 6 months post-intervention
measure: Additional preliminary clinical outcomes will be assessed for the generation of evidence-based hypotheses, including differential impact on healthcare utilization.
timeFrame: 1 month, 3 months, and 6 months post-intervention
measure: Finally, the impact on ETS outcomes of having an infant with Bronchopulmonary Dysplasia will be explored.
timeFrame: 1 month, 3 months, and 6 months post-intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Angela L Stotts, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: