Allergy and AsthmaNCT01205659
Allergy and Ashthma in 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
Allergy and Asthma study of children (3 - 7 Years of age) who participated in randomized trials of supplemented infant formula during infancy conducted by The Retina Foundation of the Southwest . Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Allergy and Asthma
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Dec 2009
- 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 3 to 7 years
- All sexes
- Child
Study population: Children who participated in randomizaed trials of supplemented infant formula conducted by The Retina Foundation of the Southwest during infancy
Who may be able to join
- Children who participated in randomized trials of supplemented infant formula conducted by The Retina Foundation of the Southwest during infancy
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
The Retina Foundation of The Southwest
Dallas, Texas, 75231
About this study
Official title: Allergy and Asthma in Children Who Were Fed Supplemented Infant Formula (3-7 Years of Age)
Allergy and Asthma study of children (3 - 7 Years of age) who participated in randomized trials of supplemented infant formula during infancy conducted by The Retina Foundation of the Southwest .
- Conditions
- Allergy and Asthma
- 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 for ages 3 - 7 years
Secondary outcomes (2)
Prevalence of Serious Adverse Events in medical records
Long-term growth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy and AsthmaStudies 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
- Cohort
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205659
- Sponsor's protocol ID
- 8611
- Status last verified
- Sep 2010
- First submitted
- 17 Sep 2010
- Last updated
- 20 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergy and Asthma in Children Who Were Fed Supplemented Infant Formula (3-7 Years of Age)
- ClinicalTrials.gov ID
- NCT01205659
- Acronym / sponsor ID
- 8611
- Conditions
- Allergy and Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Sep 2010 (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.
Allergy and Asthma study of children (3 - 7 Years of age) who participated in randomized trials of supplemented infant formula during infancy conducted by The Retina Foundation of the Southwest .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Age groups
- Child
- Study population
- Children who participated in randomizaed trials of supplemented infant formula conducted by The Retina Foundation of the Southwest during infancy
Key inclusion criteria (1 listed)
- Children who participated in randomized trials of supplemented infant formula conducted by The Retina Foundation of the Southwest during infancy
Key exclusion criteria (1 listed)
- -
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 for ages 3 - 7 years
2 secondary outcomes
Prevalence of Serious Adverse Events in medical records
Long-term growth
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 20 Sep 2010.
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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 20 Sep 2010. 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 for ages 3 - 7 years. 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 20 Sep 2010.