AllergyNCT00740974
Allergy and Asthma Following Children Who Were Fed Supplemented Infant Formula
An observational study of Allergy and Asthma, run by Mead Johnson Nutrition at 1 site in United States.
Trial summary
Long-term cognitive outcome study of children who participated in randomized trials of LCP-supplemented formula during infancy. Read more about this study
- Who is it for?
- Ages 5 days to 12 monthsHealthy volunteers can take part
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 5 days to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: children previously randomized in a clinical study consuming LCP-supplemented infant formula
Who may be able to join
- children previously randomized in a clinical study consuming LCP-supplemented infant formula
Who cannot join
- children who did not previously participate in a randomized clinical study consuming LCP-supplemented infant formula
Trial locations and contacts
1 site in 1 country.
United States1 site
Retina Foundation of the Southwest
Dallas, Texas, 75231
About this study
Long-term cognitive outcome study of children who participated in randomized trials of LCP-supplemented formula during infancy.
- Medical subject headings
- Hypersensitivity, Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of asthma and allergy related diagnosis in medical records during first 3 years of life.
Measured: after first 3 years of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies 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
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740974
- Sponsor's protocol ID
- 8580
- Status last verified
- Aug 2008
- First submitted
- 22 Aug 2008
- Last updated
- 25 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergy and Asthma Following Children Who Were Fed Supplemented Infant Formula
- ClinicalTrials.gov ID
- NCT00740974
- Acronym / sponsor ID
- 8580
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- First posted
- 25 Aug 2008 (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.
Long-term cognitive outcome study of children who participated in randomized trials of LCP-supplemented formula during infancy.
Study design
Who may qualify
- Ages
- 5 days to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- children previously randomized in a clinical study consuming LCP-supplemented infant formula
Key inclusion criteria (1 listed)
- children previously randomized in a clinical study consuming LCP-supplemented infant formula
Key exclusion criteria (1 listed)
- children who did not previously participate in a randomized clinical study consuming LCP-supplemented infant formula
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
Prevalence of asthma and allergy related diagnosis in medical records during first 3 years of life.
Time frame: after first 3 years of life
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 25 Aug 2008.
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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 Allergy and Asthma, run by Mead Johnson Nutrition 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 1 inclusion and 1 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 25 Aug 2008. 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.
What does the primary outcome measure?
Prevalence of asthma and allergy related diagnosis in medical records during first 3 years of life. (time frame: after first 3 years of life). It is what the study was designed to measure, not a finding.
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 25 Aug 2008.