NCT00683228

Brief Summary

This is a pilot study that aims to

  1. 1.Evaluate the effectiveness of using a structured tobacco cessation education program, CEASE (Clinical effort against second hand smoke exposure), NY, delivered by pediatric residents in the outpatient continuity clinic of the pediatric residency program in reducing the exposure of infants to second hand smoke.
  2. 2.Evaluate the efficacy of using a second hand smoke exposure biomarker, Urine cotinine level measurement and feedback as an adjunct to counseling.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

1.7 years

First QC Date

May 20, 2008

Last Update Submit

November 26, 2014

Conditions

Keywords

Second hand Smoke

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effectiveness of using a structured tobacco cessation education program, CEASE,delivered by pediatric residents in the outpatient continuity clinic of the pediatric residency program in reducing the exposure of infants to second hand smoke.

    Begining of study and at completion of study

Secondary Outcomes (1)

  • Evaluate the efficacy of using a second hand smoke exposure biomarker, Urine cotinine level measurement and feedback as an adjunct to counseling

    first visit, 4 month visit, 9 month visit

Study Arms (1)

Counseling

OTHER

some caregivers will be provided counseling related to the hazards of secondhand smoke exposure

Behavioral: Counseling

Interventions

CounselingBEHAVIORAL

Consecutive newborns exposed to secondhand smoke will be recruited into the study and randomized to have parents receive or not receive specific counselling on harmful effects of SHS exposure. Urine cotinine will be measured at several points during the study for each group

Counseling

Eligibility Criteria

Age1 Day - 15 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Newborn infants up to 15 days of age

You may not qualify if:

  • Non English speaking family and infants with significant medical problems at birth needing NICU stay
  • foster children and wards of state

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Interventions

Counseling

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Donna Bacchi, Md

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2008

First Posted

May 23, 2008

Study Start

October 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations