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Clinical Trials/NCT01726062
NCT01726062
Completed
Phase 2

Motivational Incentives to Reduce Secondhand Smoke in NICU Infants' Homes (The Baby's Breath II Project)

The University of Texas Health Science Center, Houston1 site in 1 country360 target enrollmentAugust 2012

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Exposure to Secondhand Smoke in Neonatal Infants
Sponsor
The University of Texas Health Science Center, Houston
Enrollment
360
Locations
1
Primary Endpoint
Infant Second-Hand Smoke Exposure via Urine Cotinine
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

A randomized, controlled, parallel group design will be used to test whether a Secondhand Smoke Exposure program initiated in the hospital and completed in the home using motivational interviewing plus motivational incentives (MI+) is more effective than Conventional Care (CC) with Neonatal Incentives Care Unit Infants' parents.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
January 30, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Angela Stotts

Associate Professor - Family Medicine

The University of Texas Health Science Center, Houston

Eligibility Criteria

Inclusion Criteria

  • Have an infant that is at least 1 week prior to the estimated date of hospital discharge in the NICU at Children's Memorial Hermann Hospital (CMHH)
  • Report at least one person living in the home who smokes
  • Agree to attend intervention sessions and to invite other household members
  • Live within 50 miles of our center
  • Have access to a telephone.

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, and speak English or Spanish
  • Inability or unwillingness to provide signed consent for participation
  • Inability or unwillingness to meet study requirements, including home visits for data collection and intervention purposes.

Outcomes

Primary Outcomes

Infant Second-Hand Smoke Exposure via Urine Cotinine

Time Frame: Follow-up visit 4 months post-treatment

Infant Second-Hand Smoke Exposure (SHSe) measures will be determined via urine cotinine.

Secondary Outcomes

  • Secondhand Smoke Exposure outcomes(Change from Baseline to the 4 months post-treatment followup)

Study Sites (1)

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