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

NCT ID: NCT04155697

Last Updated: 2022-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-07

Study Completion Date

2018-09-11

Brief Summary

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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.

Detailed Description

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Conditions

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Nicotine Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Hand washing with soap for thirdhand smoke removal

Group Type ACTIVE_COMPARATOR

2% Chlorohexidine Gluconate soap

Intervention Type DRUG

Participants will wash hands for 30 seconds with 2% Chlorohexidine Gluconate soap.

Ethyl alcohol-based sanitizer for thirdhand smoke removal

Group Type ACTIVE_COMPARATOR

62% ethyl alcohol-based hand sanitizer

Intervention Type DRUG

Participants will apply 62% ethyl alcohol-based hand sanitizer for 30 seconds

Interventions

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2% Chlorohexidine Gluconate soap

Participants will wash hands for 30 seconds with 2% Chlorohexidine Gluconate soap.

Intervention Type DRUG

62% ethyl alcohol-based hand sanitizer

Participants will apply 62% ethyl alcohol-based hand sanitizer for 30 seconds

Intervention Type DRUG

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Thomas Francis Northrup

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thomas Northrup, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

References

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Northrup TF, Stotts AL, Suchting R, Khan AM, Klawans MR, Green C, Hoh E, Hovell MF, Matt GE, Quintana PJE. Handwashing Results in Incomplete Nicotine Removal from Fingers of Individuals who Smoke: A Randomized Controlled Experiment. Am J Perinatol. 2022 Nov;39(15):1634-1642. doi: 10.1055/s-0041-1736287. Epub 2021 Oct 11.

Reference Type DERIVED
PMID: 34634832 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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R03HD088847

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HSC-MS-15-0614 (sub-study)

Identifier Type: -

Identifier Source: org_study_id

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