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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04155697
Recruitment Status : Completed
First Posted : November 7, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Thomas Francis Northrup, The University of Texas Health Science Center, Houston

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Nicotine Exposure Drug: 2% Chlorohexidine Gluconate soap Drug: 62% ethyl alcohol-based hand sanitizer Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Thirdhand Smoke Contamination in a Neonatal Intensive Care Unit (NICU)
Actual Study Start Date : June 7, 2017
Actual Primary Completion Date : September 11, 2018
Actual Study Completion Date : September 11, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155697


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Thomas Northrup, PhD The University of Texas Health Science Center, Houston
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Responsible Party: Thomas Francis Northrup, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04155697    
Other Study ID Numbers: HSC-MS-15-0614 (sub-study)
R03HD088847 ( U.S. NIH Grant/Contract )
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Ethanol
Hand Sanitizers
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Disinfectants