Infant NewbornPhase 3NCT01380886
Growth and Tolerance of Young Infants Fed Infant Formulas
A Phase 3 study testing experimental infant formula with alternate protein source and Infant formula powder in people with Infant Newborn, run by Abbott Nutrition at 12 sites in United States.
Trial summary
This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula. Read more about this study
- Who is it for?
- Ages Up to 8 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Newborn
- What is being tested?
- experimental infant formula with alternate protein source and Infant formula powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 209 participants
- Where
- 12 sitesUnited States
- Study dates
- Jun 2011to Dec 2011
- Phase
- Phase 3
- 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 8 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy infant
- full term
- birth weight > 2490 g
- 0 to 8 days of age
- parent/physician agree to not use medications affecting tolerance/growth
- parent agrees to sole source feeding of study formula
- parent agrees to not use vitamin/mineral supplements
- parent has signed consent/HIPAA authorization
Who cannot join
- any maternal, fetal, or infant history affecting growth and tolerance
- participation in any other study not preapproved by Abbott
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Cary Pediatric Center
Cary, North Carolina, 27518
MetroHealth Medical Center
Cleveland, Ohio, 44109
Ohio Pediatric Research Association, INC.
Huber Heights, Ohio, 45424
Northpoint Pedicatrics, LLC
Indianapolis, Indiana, 46038
Clinical Research Center of Nevada
Las Vegas, Nevada, 89104
DCOL Center for Clinical Research
Longview, Texas, 75605
Institute of Clinical Research
Mayfield Heights, Ohio, 44124
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360
Springs Medical Research, LLC
Owensboro, Kentucky, 42303
The Cleveland Pediatric Research Center
Parma, Ohio, 44129
Sanford Clinic Family Medicine
Sioux Falls, South Dakota, 57105
SCORE Physician Alliance, LLC
St. Petersburg, Florida, 33710
About this study
This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.
- Conditions
- Infant Newborn
- Being tested
- experimental infant formula with alternate protein source, Infant formula powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental infant formula with alternate protein sourceOther
experimental infant formula to be fed ad libitum
Infant formula powderOther
powdered infant formula to be fed ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Infant formula, alternate protein source | Experimental | Experimental infant formula with alternate protein source Receives: Other: experimental infant formula with alternate protein source |
| Infant formula powder | Active comparator | Infant formula powder Receives: Other: Infant formula powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Measured: 119 days
Secondary outcomes (2)
gastrointestinal tolerance
Stool characteristics, number of stools per day, and number of feedings associated with spit up or vomit
Measured: 119 days
Anthropometric variables
Length gain per day and head circumference gain per day
Measured: 119 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant NewbornStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marlene Borschel, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380886
- Sponsor's protocol ID
- AK92
- Status last verified
- Feb 2013
- First submitted
- 16 Jun 2011
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Tolerance of Young Infants Fed Infant Formulas
- ClinicalTrials.gov ID
- NCT01380886
- Acronym / sponsor ID
- AK92
- Conditions
- Infant Newborn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 27 Jun 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 is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant formula, alternate protein source | Experimental | Other: experimental infant formula with alternate protein sourceExperimental infant formula with alternate protein source |
| Infant formula powder | Active comparator | Other: Infant formula powderInfant formula powder |
Who may qualify
- Ages
- Up to 8 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- healthy infant
- full term
- birth weight > 2490 g
- 0 to 8 days of age
- parent/physician agree to not use medications affecting tolerance/growth
Key exclusion criteria (2 listed)
- any maternal, fetal, or infant history affecting growth and tolerance
- participation in any other study not preapproved by Abbott
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental infant formula with alternate protein sourceexperimental infant formula to be fed ad libitum | Other | Infant formula, alternate protein source |
| Infant formula powderpowdered infant formula to be fed ad libitum | Other | Infant formula powder |
Primary outcome
Weight gain
Time frame: 119 days
2 secondary outcomes
gastrointestinal tolerance
Time frame: 119 days
Anthropometric variables
Time frame: 119 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 15 Feb 2013.
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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.
Marlene Borschel, PhD study chair
Abbott Nutrition
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing experimental infant formula with alternate protein source and Infant formula powder in people with Infant Newborn, run by Abbott Nutrition at 12 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 8 inclusion and 2 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 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Weight gain (time frame: 119 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 15 Feb 2013.