Quality of LifeNCT01177930
Evaluation of the Health Related Quality of Life and Disease Prevalence of Children From Spain at 6-8 Years of Age Who Participated in a Qualifying Infant Formula Study at Birth
An observational study of Quality of Life, run by Mead Johnson Nutrition at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the influence of the type of feeding in the first year of life on the behavior and health-related quality of life at 6-8 years of age. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Oct 2009to May 2011
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children 6 - 8 years of age
Who may be able to join
- Father, mother or legal representative of a child who was included in the qualifying study
- Child 6 - 8 years of age
- Written informed consent of the father, mother or legal representative
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the influence of the type of feeding in the first year of life on the behavior and health-related quality of life at 6-8 years of age.
- Conditions
- Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Feeding with milk with DHA and ARA | Not described | |
| Feeding with milk without DHA and ARA | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of the type of feeding from the first year of life on the quality of life in the same children at 6 - 8 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startOct 2009
- Primary completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Prospective
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177930
- Sponsor's protocol ID
- 6004
- Status last verified
- Jun 2011
- First submitted
- 6 Aug 2010
- Last updated
- 22 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Health Related Quality of Life and Disease Prevalence of Children From Spain at 6-8 Years of Age Who Participated in a Qualifying Infant Formula Study at Birth
- ClinicalTrials.gov ID
- NCT01177930
- Acronym / sponsor ID
- 6004
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- May 2011 (actual)
- First posted
- 9 Aug 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.
The purpose of this study is to evaluate the influence of the type of feeding in the first year of life on the behavior and health-related quality of life at 6-8 years of age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feeding with milk with DHA and ARA | – | – |
| Feeding with milk without DHA and ARA | – | – |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children 6 - 8 years of age
Key inclusion criteria (3 listed)
- Father, mother or legal representative of a child who was included in the qualifying study
- Child 6 - 8 years of age
- Written informed consent of the father, mother or legal representative
Key exclusion criteria (1 listed)
- None
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
Influence of the type of feeding from the first year of life on the quality of life in the same children at 6 - 8 years of age
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 22 Jun 2011.
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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 Quality of Life, run by Mead Johnson Nutrition at 1 site in Spain.
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 3 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 22 Jun 2011. 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 Spain. 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?
Influence of the type of feeding from the first year of life on the quality of life in the same children at 6 - 8 years of age. 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 22 Jun 2011.