MilkScreen Home Test for Alcohol in Breast Milk
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|ClinicalTrials.gov Identifier: NCT00851656|
Recruitment Status : Completed
First Posted : February 26, 2009
Last Update Posted : February 26, 2009
|Condition or disease|
|Alcohol Concentrations in Body Fluids|
The Milkscreen Test for alcohol in Breast Milk is intended for use by lactating mothers as a rapid qualitative detection for the presence of alcohol in their breast milk prior to offering the breast milk to their nursing infant. This study will obtain data to demonstrate the sensitivity and specificity of MilkScreen™ compared to the reference method, Gas Chromatography (GC) for alcohol content and will additionally provide validation of the usability of the device by for over-the-counter use.
The study will enroll approximately 50 lactating mothers who will come into a center in small groups in a contrived social setting like a wine tasting. Upon completion of informed consent and demonstration of meeting inclusion/exclusion criteria, subjects will be tested with disposable breathalyzer test and baseline breast milk samples provided. The baseline breast milk samples will be tested with the test article by the subject. Aliquots from the same samples will be prepared for testing by an outside lab with GC and with the test article.
Subjects will be asked to provide baseline demographics such as height and weight, days since birth of child, race/ethnicity, and information about any prescription or OTC drugs, herbal compounds or vitamins they have taken in the previous 72 hours.
Subjects will be provided with up to 3 standard alcohol drinks over the course of a two hour period. At prescribed time intervals following consumption, subjects will be asked to provide a breast milk sample and to submit to a breathalyzer test. Each breast milk sample will be tested by the subject with the test article following the labeling instructions only and the sample will also be aliquoted into tightly sealing, low head space samples containers for method comparison testing by an outside lab on GC and again with MilkScreen™.
Subjects will be asked to drink at least one drink, but may ingest up to two additional alcoholic beverages. Each subject's intoxication state will be monitored before each additional drink is provided and will not be allowed to consume additional drinks if their BAC as measured by the disposable breathalyzer device exceeds 0.10% (100 mg/dL). All drinks will be measured for consistency and subjects will be asked to self report whether they finished their drink at the point when samples are taken. Subjects will be provided with transportation using designated non-drinking drivers.
Samples of breast milk taken both prior to and following the ingestion of alcohol will be coded and thereby blinded to the lab. The lab will run both GC and MilkScreen™ testing on each sample and report the results as paired. This data will be analyzed to demonstrate that the MilkScreen™ Home Test for Alcohol in Breast Milk has sufficient sensitivity and specificity as compared to the reference method, GC, to support the test article's intended use.
Subjects will be asked to complete a questionnaire on the usability of the labeling instructions on MilkScreen™ Home Test for Alcohol in Breast Milk to demonstrate that consumers can use the directions properly to test their breast milk for the presence of alcohol and properly interpret the results.
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|Official Title:||MilkScreen Home Test for Alcohol in Breast Milk Clinical Study|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||July 2008|
|Actual Study Completion Date :||July 2008|
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): NCT00851656
|United States, California|
|Zeis Consulting Group|
|San Marcos, California, United States, 92078|