Thirdhand Smoke Contamination in a Neonatal Intensive Care Unit (NICU)

May 3, 2022 updated by: Thomas Francis Northrup, The University of Texas Health Science Center, Houston

The purpose of the study is to quantify the efficacy of hand washing (HW) and ethyl alcohol-based hand sanitizer (S) for third-hand smoke (THS) removal in a sub-sample of non-staff smokers using nicotine wipes on adjacent fingers before and after HW/S.

The hypotheses are that detectable levels of surface nicotine will remain on participants' fingers, regardless of hand washing (HW) and ethyl alcohol-based hand sanitizer (S) attempts and that greater finger levels of surface nicotine will remain after alcohol sanitization compared to hand washing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria ():

  • Any non-staff participants visiting the NICU (including friends and family members of the infants' caregivers)
  • Consented to and provided a finger wipe
  • Report being a smoker
  • Smoking status verified by an exhaled carbon monoxide (CO) level of >7 parts per million

Exclusion Criteria:

  • Unwilling to comply with research procedures (i.e., finger wipes)
  • Does not speak English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hand washing with soap for thirdhand smoke removal
Drug: 2% Chlorohexidine Gluconate soap
Participants will wash hands for 30 seconds with 2% Chlorohexidine Gluconate soap.
Active Comparator: Ethyl alcohol-based sanitizer for thirdhand smoke removal
Drug: 62% ethyl alcohol-based hand sanitizer
Participants will apply 62% ethyl alcohol-based hand sanitizer for 30 seconds

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nicotine level on finger #1
Time Frame: baseline
Nicotine will be sampled from one finger of each participant's dominant hand (thumb, index, or middle finger). Finger will be wiped and nicotine level will be quantified.
baseline
Nicotine level on finger #2
Time Frame: 5 minutes after hand washing or sanitizing
Nicotine will be sampled from one finger of each participant's dominant hand (thumb, index, or middle finger). Finger will be wiped and nicotine level will be quantified.
5 minutes after hand washing or sanitizing
Nicotine level on finger #3
Time Frame: 1 hour after hand washing or sanitizing
Nicotine will be sampled from one finger of each participant's dominant hand (thumb, index, or middle finger). Finger will be wiped and nicotine level will be quantified.
1 hour after hand washing or sanitizing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Thomas Northrup, PhD, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2017

Primary Completion (Actual)

September 11, 2018

Study Completion (Actual)

September 11, 2018

Study Registration Dates

First Submitted

November 5, 2019

First Submitted That Met QC Criteria

November 5, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

May 9, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-15-0614 (sub-study)
  • R03HD088847 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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