GrowthNCT03276884
Growth and Tolerance of Young Infants
A study testing Experimental Infant Formula in people with Growth, run by Abbott Nutrition at 22 sites in United States.
Trial summary
To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas. Read more about this study
- Who is it for?
- Ages Up to 8 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Experimental Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 22 sitesUnited States
- Study dates
- 11 Oct 2017to 8 Nov 2018
- Phase
- Interventional
- 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
- Subject is judged to be in good health.
- Singleton from a full-term birth with a gestational age of 37 - 42 weeks.
- Birth weight was ≥ 2490 g (~5 lbs. 8 oz.).
- Subject is between 0 and 8 days of age at enrollment.
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
- Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D-containing supplements), solid foods or juices to their infant from enrollment through the duration of the study.
- Subject's parent(s) has voluntarily signed and dated an ICF prior to any participation in the study.
Who cannot join
- An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance.
- Subject participates in another study that has not been approved as a concomitant study.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
Medical Research South
Charleston, South Carolina, 29407
Coastal Pediatric Research 3002
Charleston, South Carolina, 29414
Southeastern Pediatric Associates
Dothan, Alabama, 36305
Deaconess Clinic, Inc.
Evansville, Indiana, 47713
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, 45014
Vilo Research Group Inc
Houston, Texas, 77017
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401
Children's Research, LLC
Lake Mary, Florida, 32746
Tanner Clinic
Layton, Utah, 84041
Women's Clinic of Lincoln, PC
Lincoln, Nebraska, 68510
Memphis & Shelby County Pediatric Group
Memphis, Tennessee, 38116
Institute of Clinical Research, LLC
Mentor, Ohio, 44060
The Cleveland Pediatric Research Center, LLC
Middleburg Heights, Ohio, 44130
Coastal Pediatric Associates 3004
Mt. Pleasant, South Carolina, 29464
Saltzer Medical Group
Nampa, Idaho, 83686
Coastal Pediatric Research 3003
North Charleston, South Carolina, 29406
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360
Springs Medical Research
Owensboro, Kentucky, 42303
Southwest Children's Research Associates, PA
San Antonio, Texas, 78229
Score Physician Alliance, LLC
St. Petersburg, Florida, 33710
Watching Over Mothers and Babies
Tucson, Arizona, 85712
About this study
Official title: Growth and Tolerance of Young Infants Fed Amino Acid-Based Formulas
To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.
- Conditions
- Growth
- Being tested
- Experimental Infant Formula, Control Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Infant FormulaOther
amino acid-based infant formula powder
Control Infant FormulaOther
amino acid-based infant formula powder
| Study group | Role | What they receive |
|---|---|---|
| Experimental Infant Formula | Experimental | Infant formula powder to be fed ad libitum Receives: Other: Experimental Infant Formula |
| Control Infant Formula | Active comparator | Infant formula powder to be fed ad libitum Receives: Other: Control Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain
Infant scale
Measured: Study Day 14 to Study Day 119
Secondary outcomes (4)
GI tolerance
Parent completed questionnaires
Measured: Study Day 1 to Study Day 119
Length
Length board
Measured: Study Day 1 to Study Day 119
Head Circumference
Measure tape
Measured: Study Day 1 to Study Day 119
Weight
Infant scale
Measured: Study Day 1 to Study Day 119
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start11 Oct 2017
- Primary completion8 Nov 2018
- Study completion8 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Kajzer, MS, RD, LD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276884
- Sponsor's protocol ID
- AL23
- Status last verified
- Nov 2018
- First submitted
- 7 Sep 2017
- Last updated
- 3 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Tolerance of Young Infants Fed Amino Acid-Based Formulas
- ClinicalTrials.gov ID
- NCT03276884
- Acronym / sponsor ID
- AL23
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2017 (actual)
- Primary completion
- 8 Nov 2018 (actual)
- Study completion
- 8 Nov 2018 (actual)
- First posted
- 8 Sep 2017 (actual)
- 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.
To compare growth and tolerance of healthy term infants fed two amino acid-based infant formulas.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Infant Formula | Experimental | Other: Experimental Infant FormulaInfant formula powder to be fed ad libitum |
| Control Infant Formula | Active comparator | Other: Control Infant FormulaInfant formula powder to be fed ad libitum |
Who may qualify
- Ages
- Up to 8 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Subject is judged to be in good health.
- Singleton from a full-term birth with a gestational age of 37 - 42 weeks.
- Birth weight was ≥ 2490 g (~5 lbs. 8 oz.).
- Subject is between 0 and 8 days of age at enrollment.
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
Key exclusion criteria (3 listed)
- An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Subject is taking and plans to continue medications, home remedies, herbal preparations, prebiotics, probiotics or rehydration fluids that might affect gastrointestinal (GI) tolerance.
- Subject participates in another study that has not been approved as a concomitant study.
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 Formulaamino acid-based infant formula powder | Other | Experimental Infant Formula |
| Control Infant Formulaamino acid-based infant formula powder | Other | Control Infant Formula |
Primary outcome
Weight Gain
Time frame: Study Day 14 to Study Day 119
Infant scale
4 secondary outcomes
GI tolerance
Time frame: Study Day 1 to Study Day 119
Length
Time frame: Study Day 1 to Study Day 119
Head Circumference
Time frame: Study Day 1 to Study Day 119
Weight
Time frame: Study Day 1 to Study Day 119
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 3 Dec 2018.
- Individual participant dataSharing planned: Undecided
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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.
Jan Kajzer, MS, RD, LD study chair
Abbott Nutrition
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Infant Formula in people with Growth, run by Abbott Nutrition at 22 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 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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?
Weight Gain (time frame: Study Day 14 to Study Day 119). 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 3 Dec 2018.