Alcohol Concentrations in Body FluidsNCT00851656
MilkScreen Home Test for Alcohol in Breast Milk
An observational study of Alcohol Concentrations in Body Fluids, run by UpSpring Baby, Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the performance of the UpSpring Milkscreen Test for Alcohol in Breast Milk to detect alcohol in breast milk from lactating women. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alcohol Concentrations in Body Fluids
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Lactating women, 21 years and older.
Who may be able to join
- 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 6 hours.
- Willing to attend single session study for 3-4 hours duration until their BAC drops below 0.06%
Show all 9Show fewer
- Willing to accept designated driver or study-supplied transportation
- Willing to agree to not breast feed their infant for 2 hour following leaving the study session
- English language fluency
Who cannot join
- Distance of more than 25 miles from study site
- Pregnant (hCG test will be administered prior to alcohol consumption)
- Communicable diseases (e.g., Flu)
- HIV Positive
- History of Alcoholism (Recorded on the CRF)
- Arriving to the study session with a BAC at or below 0.01%
- Any medical condition which precludes the subject from drinking alcohol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MilkScreen Home Test for Alcohol in Breast Milk Clinical Study
The purpose of this study is to evaluate the performance of the UpSpring Milkscreen Test for Alcohol in Breast Milk to detect alcohol in breast milk from lactating women.
Read the detailed description
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.
- Conditions
- Alcohol Concentrations in Body Fluids
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2009 (estimated)
- Study startMay 2008
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Concentrations in Body FluidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- UpSpring Baby, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00851656
- Sponsor's protocol ID
- 4001-001
- Status last verified
- Feb 2009
- First submitted
- 25 Feb 2009
- Last updated
- 26 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MilkScreen Home Test for Alcohol in Breast Milk Clinical Study
- ClinicalTrials.gov ID
- NCT00851656
- Acronym / sponsor ID
- 4001-001
- Conditions
- Alcohol Concentrations in Body Fluids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- UpSpring Baby, Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 26 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the performance of the UpSpring Milkscreen Test for Alcohol in Breast Milk to detect alcohol in breast milk from lactating women.
Detailed description
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Lactating women, 21 years and older.
Key inclusion criteria (9 listed)
- 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 6 hours.
Key exclusion criteria (7 listed)
- Distance of more than 25 miles from study site
- Pregnant (hCG test will be administered prior to alcohol consumption)
- Communicable diseases (e.g., Flu)
- HIV Positive
- History of Alcoholism (Recorded on the CRF)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Concentrations in Body Fluids, run by UpSpring Baby, Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2009.