Healthy Term InfantsPhase 3NCT01137877
Growth and Tolerance of Healthy Term Infants to a New Infant Formula
A Phase 3 study testing Milk based infant formula powder, Investigational Infant Formula #1 and Investigational Infant Formula #2 in people with Healthy Term Infants, run by Abbott Nutrition at 20 sites in United States.
Trial summary
The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants. Read more about this study
- Who is it for?
- Ages 1 day to 11 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Term Infants
- What is being tested?
- Milk based infant formula powder, Investigational Infant Formula #1 and Investigational Infant Formula #2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 399 participants
- Where
- 20 sitesUnited States
- Study dates
- May 2010to Oct 2010
- 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 1 day to 11 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- in good health
- singleton full term birth
- Birth weight > 2490 g.
- Infant is between 0 and 11 days of age
- Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance
- If formula-fed, parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
- If human milk-fed, parent(s) confirm their intention to feed their infant human milk as the sole source of nutrition
- not consuming vitamin or mineral supplements, solid foods or juices through the duration of the study
Who cannot join
- adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Cary Pediatric Center
Cary, North Carolina, 27518
Wayzata Children's Clinic Ridgeview Research
Chaska, Minnesota, 55318
Dayton Clinical Research
Dayton, Ohio, 45406
New England Center for Clinical Research, Inc
Fall River, Massachusetts, 02720
Ohio Pediatric Research Association, Inc
Huber Heights, Ohio, 45424
Northpoint Pediatrics
Indianapolis, Indiana, 46038
Clinical Research Center of Nevada
Las Vegas, Nevada, 89123
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska, 68504
Arkansas Children's Hospital Research
Little Rock, Arkansas, 72202
DCOL Center for Clinical Research
Longview, Texas, 75605
University of Louisville Department of Pediatrics
Louisville, Kentucky, 40202
Facey Medical Foundation
Mission Hills, California, 91345
Norwich Pediatric Group
Norwich, Connecticut, 06360
Parma Pediatrics
Parma, Ohio, 44129
All Women's Healthcare of West Broward, Inc
Plantation, Florida, 33324
Sanford Clinic Family Medicine 34th and Kiwanis
Sioux Falls, South Dakota, 57105
Rockwood Clinic North Pediatrics
Spokane, Washington, 99218
SCORE Physician Alliance LLC
St. Petersburg, Florida, 33710
USF College of Medicine, USF Health, Department of Pediatrics
Tampa, Florida, 33606
Comprehensive Pediatrics, Inc
Westlake, Ohio, 44145
About this study
The objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.
- Conditions
- Healthy Term Infants
- Being tested
- Milk based infant formula powder, Investigational Infant Formula #1, Investigational Infant Formula #2, Human Milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milk based infant formula powderOther
milk based infant formula ad lib
Investigational Infant Formula #1Other
Milk based infant formula ad lib
Investigational Infant Formula #2Other
Milk based infant formula powder ad lib
Human MilkOther
Human milk ad lib
| Study group | Role | What they receive |
|---|---|---|
| Infant Formula #1 | Active comparator | Milk-based Infant Formula Powder Receives: Other: Milk based infant formula powder |
| Investigational Infant Formula #1 | Experimental | Investigational Milk-based Infant Formula Powder Receives: Other: Investigational Infant Formula #1 |
| Investigational Infant Formula #2 | Experimental | Investigational Milk based infant formula powder Receives: Other: Investigational Infant Formula #2 |
| Human Milk | Active comparator | Reference group Receives: Other: Human Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight gain
Measured: 14 to 119 days of age
Secondary outcomes (2)
GI tolerance
Measured: 14 to 119 days of age
anthropometrics
Measured: 14 to 119 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: The control product was recalled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Term InfantsStudies 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
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Timberly Williams, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137877
- Sponsor's protocol ID
- AK66
- Status last verified
- Nov 2010
- First submitted
- 3 Jun 2010
- Last updated
- 25 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Tolerance of Healthy Term Infants to a New Infant Formula
- ClinicalTrials.gov ID
- NCT01137877
- Acronym / sponsor ID
- AK66
- Conditions
- Healthy Term Infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The control product was recalled.
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 7 Jun 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 objective of this study is to evaluate the effect of two experimental milk-based infant formulas on the growth and gastrointestinal (GI) tolerance of term infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Infant Formula #1 | Active comparator | Other: Milk based infant formula powderMilk-based Infant Formula Powder |
| Investigational Infant Formula #1 | Experimental | Other: Investigational Infant Formula #1Investigational Milk-based Infant Formula Powder |
| Investigational Infant Formula #2 | Experimental | Other: Investigational Infant Formula #2Investigational Milk based infant formula powder |
| Human Milk | Active comparator | Other: Human MilkReference group |
Who may qualify
- Ages
- 1 day to 11 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- in good health
- singleton full term birth
- Birth weight > 2490 g.
- Infant is between 0 and 11 days of age
- Infants using medications , home remedies , herbal preparations, prebiotics, probiotics or rehydration fluids that might affect GI tolerance
Key exclusion criteria (1 listed)
- adverse maternal, fetal or infant medical history with potential for effects on tolerance, growth, and/or development.
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 |
|---|---|---|
| Milk based infant formula powdermilk based infant formula ad lib | Other | Infant Formula #1 |
| Investigational Infant Formula #1Milk based infant formula ad lib | Other | Investigational Infant Formula #1 |
| Investigational Infant Formula #2Milk based infant formula powder ad lib | Other | Investigational Infant Formula #2 |
| Human MilkHuman milk ad lib | Other | Human Milk |
Primary outcome
weight gain
Time frame: 14 to 119 days of age
2 secondary outcomes
GI tolerance
Time frame: 14 to 119 days of age
anthropometrics
Time frame: 14 to 119 days of age
Results and safety
The study was stopped early (reason given: The control product was recalled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2010.
Related trials for Healthy Term Infants
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Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Recruiting
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
Healthy Term Infants
Not yet recruitingPhase 3
A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
Infant ALL
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Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
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Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
Infant Nutritional Physiological Phenomena, Infant Formula
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.
Timberly Williams, PhD study chair
Abbott Nutrition
20 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 Milk based infant formula powder, Investigational Infant Formula #1 and Investigational Infant Formula #2 in people with Healthy Term Infants, run by Abbott Nutrition at 20 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 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: stopped early, as of the sponsor's last update on 25 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 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 was stopped early (reason given: The control product was recalled.). Results are not available in the source record.
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: 14 to 119 days 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 25 Nov 2010.