Status:
UNKNOWN
MilkScreen™ Home Test for Alcohol in Breast Milk Clinical Study
Lead Sponsor:
UpSpring Baby, Ltd.
Conditions:
Alcohol in Breastmilk
Eligibility:
FEMALE
21+ years
Brief Summary
The purpose of this study is to evaluate if the UpSpring Milkscreen Alcohol Test works to detect alcohol in breast milk that will be donated during this study. This research is being done because the ...
Detailed Description
MilkScreen™ Home Test for Alcohol in Breast Milk is intended as an OTC test for the presence of alcohol in breast milk. This study will obtain data to demonstrate the agreement of MilkScreen™ compared...
Eligibility Criteria
Inclusion
- Female
- Age equal to or greater than 21 years
- Actively breast-feeding
- Willing to drink at least one alcoholic beverage (wine or beer) during study in a controlled setting
- Willing to arrive to the study session prior to consuming any alcoholic beverages within the last 24 hours.
- Willing to attend single session study for 3-4 hours duration until their BAC drops below 0.06%
- Willing to accept designated driver or study-supplied transportation
- Willing to agree to not breast feed their infant for 2 hours following departure from the study session
- English language fluency
Exclusion
- Distance of more than 25 miles from study site
- Pregnant (pregnancy test will be administered at time of study)
- Communicable diseases (e.g., Flu)
- HIV Positive
- History of Alcoholism
- Arriving to the study session with a BAC at or above 0.01%
- Any medical condition which precludes the subject from drinking alcohol
- Skilled or trained in clinical laboratory procedures
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01246661
Start Date
March 1 2010
End Date
November 1 2010
Last Update
November 23 2010
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