Respiratory SymptomsNCT01431482
Evaluation of the Composition of Human Milk and Health Outcomes in Children
An observational study of Respiratory Symptoms and Signs and Symptoms, Digestive, run by Mead Johnson Nutrition.
Trial summary
This study is an evaluation of the composition of human milk and health outcomes in children. Read more about this study
- Who is it for?
- Ages Up to 2 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Symptoms, Signs and Symptoms, Digestive, Anemia
- How many people
- 245 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Jun 2012
- 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 Up to 2 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children up to 2 years of age
Who may be able to join
- Human milk samples from mothers from a larger birth co-hort study
- Health outcomes of children from mothers from a larger birth co-hort study from birth through two years of age
Who cannot join
None listed.
About this study
This study is an evaluation of the composition of human milk and health outcomes in children.
- Conditions
- Respiratory Symptoms, Signs and Symptoms, Digestive, Anemia
- Keywords
- skin symptoms
- Medical subject headings
- Signs and Symptoms, Respiratory, Signs and Symptoms, Digestive, Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of infectious and allergic Gastrointestinal events through 2 years of age
Number of incidences of infectious and allergic Gastrointestinal events for each participant through 2 years of age
Measured: 2 years of age
Secondary outcomes (3)
Incidence of infectious and allergic respiratory events through 2 years of age
Number of incidences of infectious and allergic respiratory events for each participant through 2 years of age
Measured: 2 years of age
anthropometric measurements
participants' weight, length and head circumference
Measured: 2 years of age
Incidence of anemia in first 2 years of age
Hemoglobulin measurement
Measured: 2 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 Sep 2011 (estimated)
- Study startAug 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory SymptomsStudies 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
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugo Ribeiro, Jr, M.D., Principal investigator, Federal University of Bahia School of Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431482
- Sponsor's protocol ID
- 6010
- Status last verified
- May 2013
- First submitted
- 7 Jun 2011
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Composition of Human Milk and Health Outcomes in Children
- ClinicalTrials.gov ID
- NCT01431482
- Acronym / sponsor ID
- 6010
- Conditions
- Respiratory Symptoms, Signs and Symptoms, Digestive, Anemia
- Keywords
- skin symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Sep 2011 (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.
This study is an evaluation of the composition of human milk and health outcomes in children.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children up to 2 years of age
Key inclusion criteria (2 listed)
- Human milk samples from mothers from a larger birth co-hort study
- Health outcomes of children from mothers from a larger birth co-hort study from birth through two years of age
Key exclusion criteria (0 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
Incidence of infectious and allergic Gastrointestinal events through 2 years of age
Time frame: 2 years of age
Number of incidences of infectious and allergic Gastrointestinal events for each participant through 2 years of age
3 secondary outcomes
Incidence of infectious and allergic respiratory events through 2 years of age
Time frame: 2 years of age
anthropometric measurements
Time frame: 2 years of age
Incidence of anemia in first 2 years of age
Time frame: 2 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 14 Mar 2023.
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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.
Hugo Ribeiro, Jr, M.D. principal investigator
Federal University of Bahia School of Nutrition
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Symptoms and Signs and Symptoms, Digestive, run by Mead Johnson Nutrition.
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 2 inclusion and 0 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence of infectious and allergic Gastrointestinal events through 2 years of age (time frame: 2 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 14 Mar 2023.