Healthy Infant and Mother PairsNCT01573884
Ex Vivo Exploratory Analysis in Healthy Full-term Infants
An observational study of Healthy Infant and Mother Pairs, run by Abbott Nutrition at 2 sites in United States.
Trial summary
Exploratory analyses of the immune response in a ex vivo culture system Characterization of the composition of maternal milk and infant urine Read more about this study
- Who is it for?
- Ages Up to 17 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Infant and Mother Pairs
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2011to Feb 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 17 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: infant and mother pairs
Who may be able to join
- Infant or infant-mother pair in good health
- Infant or infant-mother pair is from smoke-free home
- Infant is a singleton, full term
- birth weight was > 2490 g
- Between 0 and 17 days of age at enrollment
- Human milk fed infants must have been exclusively human milk-fed since birth; formula fed infants must have received Similac Advance or Similac Sensitive since birth
- Parents confirm their intention not to administer vitamin or mineral supplements (excluding vitamin or mineral supplements containing vitamin D), solid foods or juices to their infant from enrollment throughout the study
Who cannot join
- An adverse maternal, fetal or infant medical history, including gestational diabetes that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Infant has been treated with antibiotics
- Participation in another study -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northpoint Pediatrics
Indianapolis, Indiana, 46256
Institute of Clinical Research
Mayfield Heights, Ohio, 44124
About this study
- Exploratory analyses of the immune response in a ex vivo culture system
- Characterization of the composition of maternal milk and infant urine
- Conditions
- Healthy Infant and Mother Pairs
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral load in cell cultures
Measured: 14 days
Secondary outcomes (1)
Changes in viral load and cytokine profiles
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Infant and Mother PairsStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Karen Goehring, MS, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573884
- Sponsor's protocol ID
- AK97
- Status last verified
- Apr 2012
- First submitted
- 6 Apr 2012
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ex Vivo Exploratory Analysis in Healthy Full-term Infants
- ClinicalTrials.gov ID
- NCT01573884
- Acronym / sponsor ID
- AK97
- Conditions
- Healthy Infant and Mother Pairs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 10 Apr 2012 (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.
- Exploratory analyses of the immune response in a ex vivo culture system
- Characterization of the composition of maternal milk and infant urine
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 17 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- infant and mother pairs
Key inclusion criteria (7 listed)
- Infant or infant-mother pair in good health
- Infant or infant-mother pair is from smoke-free home
- Infant is a singleton, full term
- birth weight was > 2490 g
- Between 0 and 17 days of age at enrollment
Key exclusion criteria (3 listed)
- An adverse maternal, fetal or infant medical history, including gestational diabetes that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Infant has been treated with antibiotics
- Participation in another study -
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
Viral load in cell cultures
Time frame: 14 days
1 secondary outcome
Changes in viral load and cytokine profiles
Time frame: 14 days
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 10 Apr 2012.
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.
Karen Goehring, MS study chair
Abbott Nutrition
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Infant and Mother Pairs, run by Abbott Nutrition at 2 sites 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 7 inclusion and 3 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 10 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Viral load in cell cultures (time frame: 14 days). 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 10 Apr 2012.