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

NCT00670280 | Completed DMC

• 1 other identifier: R40 MC 08962-01
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

  6 months post-intervention

Secondary Outcomes (4)

• 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).

  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.

  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.

  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.

  1 month, 3 months, and 6 months post-intervention

Study Arms (3)

Intervention Group

EXPERIMENTAL

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

UC Group

ACTIVE COMPARATOR

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

UC-RM Group

ACTIVE COMPARATOR

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

Interventions

Motivational Interviewing intervention BEHAVIORAL

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.

Intervention Group

Usual Care BEHAVIORAL

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.

UC Group

Usual Care - Reduced Measurement BEHAVIORAL

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.

UC-RM Group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• HRSA/Maternal and Child Health Bureau: collaborator

Study Sites (1)

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Motivational Interviewing

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Angela L Stotts, Ph.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Family Medicine

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 6, 2016

Record last verified: 2016-01

Locations

US (1)