Growth and ToleranceNCT02006992
Growth of Infants Fed Hydrolysate Formulas
A study testing RTF Infant Formula and Powder Infant Formula in people with Growth and Tolerance, run by Abbott Nutrition at 8 sites in United States.
Trial summary
Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas. Read more about this study
- Who is it for?
- Ages Up to 9 daysHealthy volunteers can take part
- Conditions the study is for
- Growth and Tolerance
- What is being tested?
- RTF Infant Formula and Powder Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2000to Nov 2000
- 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 9 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants in good health.
- Singleton, term birth with a gestational age of 37 to 42 weeks.
- Birth weight of 2500 g (5 lb 8 oz) or greater.
- Between 0 and 9 days of age at enrollment.
- Not receiving vitamin or mineral supplements.
Who cannot join
- Maternal, fetal or perinatal medical history with potential for adverse effects on growth or development.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Dreyer Medical Center
Aurora, Illinois
Kentucky Pediatric Research
Bardstown, Kentucky
NC Children's & Young Adults' Clinical Research Foundation
Chapel Hill, North Carolina
PediaResearch, LLC
Evansville, Indiana
The University of Iowa Hospitals and Clinics
Iowa City, Iowa
Children's Mercy Hospital
Kansas City, Missouri
Arkansas Children's Hospital
Little Rock, Arkansas
GrandView Medical Research
Sellersville, Pennsylvania
About this study
Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.
- Conditions
- Growth and Tolerance
- Being tested
- RTF Infant Formula, Powder Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTF Infant FormulaOther
a RTF extensively hydrolyzed infant formula
Powder Infant FormulaOther
a powdered extensively hydrolyzed infant formula.
| Study group | Role | What they receive |
|---|---|---|
| RTF Infant Formula 1 | Active comparator | a ready to feed (RTF) extensively hydrolyzed infant formula fed ad lib. Receives: Other: RTF Infant Formula |
| Powder Infant Formula 2 | Experimental | a powdered extensively hydrolyzed infant formula fed ad lib. Receives: Other: Powder Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Measured: Study day 1 to 112 days of age
Secondary outcomes (5)
Length
Measured: Study day 1 to 112 days of age
Head Circumference
Measured: Study day 1 to 112 days of age
Study Formula Intake
Measured: Enrollment to 112 days of age
Incidence of Spit Up
Measured: Enrollment to 112 days of age
Stool Pattern
Measured: Enrollment to 112 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 posted10 Dec 2013 (estimated)
- Study startMar 2000
- Primary completionNov 2000
- Study completionNov 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth and ToleranceStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marlene Borschel, RD, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02006992
- Sponsor's protocol ID
- AJ57
- Status last verified
- Dec 2013
- First submitted
- 5 Dec 2013
- Last updated
- 12 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth of Infants Fed Hydrolysate Formulas
- ClinicalTrials.gov ID
- NCT02006992
- Acronym / sponsor ID
- AJ57
- Conditions
- Growth and Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Mar 2000
- Primary completion
- Nov 2000 (actual)
- Study completion
- Nov 2000 (actual)
- First posted
- 10 Dec 2013 (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.
Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RTF Infant Formula 1 | Active comparator | Other: RTF Infant Formulaa ready to feed (RTF) extensively hydrolyzed infant formula fed ad lib. |
| Powder Infant Formula 2 | Experimental | Other: Powder Infant Formulaa powdered extensively hydrolyzed infant formula fed ad lib. |
Who may qualify
- Ages
- Up to 9 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants in good health.
- Singleton, term birth with a gestational age of 37 to 42 weeks.
- Birth weight of 2500 g (5 lb 8 oz) or greater.
- Between 0 and 9 days of age at enrollment.
- Not receiving vitamin or mineral supplements.
Key exclusion criteria (1 listed)
- Maternal, fetal or perinatal medical history with potential for adverse effects on growth 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 |
|---|---|---|
| RTF Infant Formulaa RTF extensively hydrolyzed infant formula | Other | RTF Infant Formula 1 |
| Powder Infant Formulaa powdered extensively hydrolyzed infant formula. | Other | Powder Infant Formula 2 |
Primary outcome
Weight
Time frame: Study day 1 to 112 days of age
5 secondary outcomes
Length
Time frame: Study day 1 to 112 days of age
Head Circumference
Time frame: Study day 1 to 112 days of age
Study Formula Intake
Time frame: Enrollment to 112 days of age
Incidence of Spit Up
Time frame: Enrollment to 112 days of age
Stool Pattern
Time frame: Enrollment to 112 days of age
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 12 Dec 2013.
Related trials for Growth and Tolerance
Recruiting
Extensively Hydrolyzed Formula Growth Monitioring Study (GMS)
Growth
Recruiting
Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements
Healthy Infants
Not yet recruitingObservational study
Growth Hormone Resistance of Beta-cells
Healthy, Obesity & Overweight
Not yet recruiting
Tolerance and Growth Outcomes of an Extensively Hydrolysed Anti-regurgitation Casein-based Formula in Infants With Cow's Milk Protein Allergy
Cow Milk Protein Allergy, FPIES
Not yet recruiting
Leveraging Optimal Tolerance in Undernourished Infants to Support Growth
Faltering Growth, Failure to Thrive
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, RD, PhD study chair
Abbott Nutrition
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RTF Infant Formula and Powder Infant Formula in people with Growth and Tolerance, run by Abbott Nutrition at 8 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 5 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: finished, as of the sponsor's last update on 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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: Study day 1 to 112 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 12 Dec 2013.