MilkScreen™ Home Test for Alcohol in Breast Milk Clinical Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by UpSpring Baby, Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
UpSpring Baby, Ltd.
ClinicalTrials.gov Identifier:
NCT01246661
First received: November 22, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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 sponsoring company, UpSpring, wants to determine if this test will work and, if it does, how well it will work to detect levels of alcohol in breast milk.


Condition
Alcohol in Breastmilk

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: MilkScreen™ Home Test for Alcohol in Breast Milk Clinical Study

Further study details as provided by UpSpring Baby, Ltd.:

Estimated Enrollment: 50
Study Start Date: March 2010
Estimated Study Completion Date: November 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
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 to the reference method, head space Gas Chromatography-Mass Spectrometry (GC-MS) for alcohol content and will additionally provide validation of the usability of the device by the intended users.

The study will use a minimum of 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-MS.

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 alcoholic beverages over the course of a three to four 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 sample containers for method comparison testing by an outside lab with GC-MS.

Subjects will be asked to drink at least one drink, but may ingest up to two additional alcoholic beverages during the course of the study. Each subject's blood alcohol content (BAC) 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 prepared such that they contain alcohol consistent with a standard alcoholic drink, as defined by the National Institute on Alcohol Abuse and Alcoholism (12 ounces of beer, 8-9 ounces of malt liquor, 5 ounces of table wine, or 1.5 ounces of liquor). 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 to and from the study site 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 GC-MS on each specimen and will report the results to the Sponsor. This data will be compared with the data reported by each subject and analyzed to demonstrate that the MilkScreen™ Home Test for Alcohol in Breast Milk agrees to a high degree to the reference method, GC-MS, 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Female subjects 21 years and older will be recruited for this study.

Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Matt Pope, UpSpring Baby
ClinicalTrials.gov Identifier: NCT01246661     History of Changes
Other Study ID Numbers: 4001-002
Study First Received: November 22, 2010
Last Updated: November 22, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 20, 2014