Infant DevelopmentNCT04006236
Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas
A study testing Experimental Infant Formula in people with Infant Development, run by Abbott Nutrition at 17 sites in United States.
Trial summary
This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein. Read more about this study
- Who is it for?
- Ages 0 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Development
- What is being tested?
- Experimental Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- 17 sitesUnited States
- Study dates
- 5 Aug 2019to 20 Sep 2021
- 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 0 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant is judged to be in good health
- Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks
- Participant's birth weight was > 2490 g (~5 lbs. 8 oz.)
- 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 vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment throughout the duration of the study
- Participant's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization
Who cannot join
- An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Participant is taking and plans to continue taking medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- Participant participates in another study that has not been approved as a concomitant study by AN.
- Participant has an allergy or intolerance to any ingredient in the study product
- Participant has been treated with antibiotics within 1 week prior to enrollment
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
MedPharmics, LLC
Albuquerque, New Mexico, 87102
Paramount Research Solutions
College Park, Georgia, 30349
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, 45014
Ventavia Research Group, Llc
Fort Worth, Texas, 76104
MedPharmics, LLC
Gulfport, Mississippi, 30503
Ventavia Research Group
Houston, Texas, 77008
Midsouth Center for Clinical Research
Memphis, Tennessee, 38116
Institute of Clinical Research, LLC
Mentor, Ohio, 44060
MedPharmics, LLC
Metairie, Louisiana, 70006
The Cleveland Pediatric Research Center, LLC
Middleburg Heights, Ohio, 44130
Quality Clinical Research Inc
Omaha, Nebraska, 68114
Springs Medical Research
Owensboro, Kentucky, 42303
MedPharmics, LLC
Phoenix, Arizona, 85015
Ventavia Research Group, LLC
Plano, Texas, 75093
Children's Hospital
Sioux Falls, South Dakota, 57105
PMG Research of Peidmont Healthcare
Statesville, North Carolina, 28625
Watching Over Mothers & Babies
Tucson, Arizona, 85712
About this study
Official title: Growth and Tolerance of Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas
This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.
- Conditions
- Infant Development
- 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
Feed Ad Libitum
Control Infant FormulaOther
Feed Ad Libitum
| Study group | Role | What they receive |
|---|---|---|
| Experimental Infant Formula | Experimental | extensively hydrolyzed casein protein Receives: Other: Experimental Infant Formula |
| Control Infant Formula | Active comparator | extensively hydrolyzed casein protein Receives: Other: Control Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Interval weight gain per day
Measured: Day of Age (DOA) 14 to 119
Secondary outcomes (4)
Length
Interval length gain per day
Measured: Study Day (SD) 1 to DOA 119
Head Circumference
Interval HC gain per day
Measured: Study Day (SD) 1 to DOA 119
Stool Characteristics
Parent Completed Diary
Measured: Study Day (SD) 1 to DOA 119
Formula Intake
Parent Completed Diary
Measured: Study Day (SD) 1 to DOA 119
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start5 Aug 2019
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlett Ramirez, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006236
- Sponsor's protocol ID
- AL33
- Status last verified
- Sep 2021
- First submitted
- 1 Jul 2019
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Tolerance of Infants Fed Extensively Hydrolyzed Casein-Based Infant Formulas
- ClinicalTrials.gov ID
- NCT04006236
- Acronym / sponsor ID
- AL33
- Conditions
- Infant Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 5 Jul 2019 (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.
This is a randomized, controlled, double-blind, multicenter parallel study to evaluate the growth, tolerance and compliance of healthy infants fed infant formulas with extensively hydrolyzed casein protein.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Infant Formula | Experimental | Other: Experimental Infant Formulaextensively hydrolyzed casein protein |
| Control Infant Formula | Active comparator | Other: Control Infant Formulaextensively hydrolyzed casein protein |
Who may qualify
- Ages
- 0 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Participant is judged to be in good health
- Participant is a singleton from a full-term birth with a gestational age of 37-42 weeks
- Participant's birth weight was > 2490 g (~5 lbs. 8 oz.)
- 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 vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment throughout the duration of the study
Key exclusion criteria (5 listed)
- An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Participant is taking and plans to continue taking medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
- Participant participates in another study that has not been approved as a concomitant study by AN.
- Participant has an allergy or intolerance to any ingredient in the study product
- Participant has been treated with antibiotics within 1 week prior to enrollment
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 FormulaFeed Ad Libitum | Other | Experimental Infant Formula |
| Control Infant FormulaFeed Ad Libitum | Other | Control Infant Formula |
Primary outcome
Weight
Time frame: Day of Age (DOA) 14 to 119
Interval weight gain per day
4 secondary outcomes
Length
Time frame: Study Day (SD) 1 to DOA 119
Head Circumference
Time frame: Study Day (SD) 1 to DOA 119
Stool Characteristics
Time frame: Study Day (SD) 1 to DOA 119
Formula Intake
Time frame: Study Day (SD) 1 to DOA 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 24 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Carlett Ramirez study chair
Abbott Nutrition
17 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 Infant Development, run by Abbott Nutrition at 17 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 6 inclusion and 5 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 24 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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 (time frame: Day of Age (DOA) 14 to 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 24 Sep 2021.