GrowthNCT01583673
Growth of Infants Fed an Amino Acid Infant Formula
A study testing Amino Acid Formula in people with Growth, run by Société des Produits Nestlé (SPN) at 17 sites in United States.
Trial summary
The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period of 4 months. Read more about this study
- Who is it for?
- Ages Up to 17 daysHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Amino Acid Formula
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 17 sitesUnited States
- Study dates
- May 2012to Jul 2013
- 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 17 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn infant
- Full-term (>= 37 weeks gestation)
- Birth weight between >= 2500 and < =4500 g
- 0-17 days of age on enrolment (day 0 is day of birth)
- Infant's mother has elected not to breastfeed and to exclusively formula-feed infant
- Study explained and written information provided with Caregiver demonstrating understanding of the given information
- Informed consent signed (parent/legal representative)
Who cannot join
- Congenital illness or malformation that may affect infant feeding and/or normal growth
- Suspected or known allergy to cow's milk protein
- Significant pre-natal and/or post-natal disease
- Any readmission to hospital (except for hyperbilirubinemia) prior to enrolment
- Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
- Infant currently participating in another conflicting clinical study
- Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Alabama Clinical Therapeutics
Birmingham, Alabama, 35205
Alabama Clinical Therapeutics/Southlake Pediatrics
Birmingham, Alabama, 35244
Blue Ridge Pediatric and Adolescent Medicine, Inc.
Boone, North Carolina, 28607
Haywood Pediatric and Adolescent Medicine Group, P.A.
Clyde, North Carolina, 28721
Ohio Pediatric Research Assn.
Dayton, Ohio, 45414
Women's Clinic of Lincoln, P.C.
Lincoln, Nebraska, 68510
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, 40291
Institute of Clinical Research
Mayfield Heights, Ohio, 44124
Nassim, MCMonigle, Mescia and Associates
New Albany, Indiana, 47150
Southwestern Medical Clinic
Niles, Michigan, 49120
Lutheran General Children's Hospital
Park Ridge, Illinois, 60068
Clinical Research Consortium Arizona
Phoenix, Arizona, 85004
Tarheel Clinical Research
Raleigh, North Carolina, 27612
Jean Brown Research
Salt Lake City, Utah, 84124
Clinical Research Specialists of Utah, Inc
Spanish Fork, Utah, 84660
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Southwestern Medical Clinic
Stevensville, Michigan, 49127
About this study
Official title: Assessment of Growth of Infants Fed an Amino Acid Based Formula
The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period of 4 months.
- Conditions
- Growth
- Being tested
- Amino Acid Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amino Acid FormulaOther
Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula
Amino Acid formulaOther
Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula
| Study group | Role | What they receive |
|---|---|---|
| Amino Acid Formula | Experimental | Hypoallergenic baby formula Receives: Other: Amino Acid Formula |
| Amino Acid commercial formula | Active comparator | Hypoallergenic commercial amino acid formula Receives: Other: Amino Acid formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain
Mean weight gain (g/day) from enrollment to 4 months of age
Measured: 4 months
Secondary outcomes (1)
tolerance
Tolerance will be evaluated based on formula intake, stool characteristics, vomiting/spitting up and behavior from enrollment to 4 months.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GrowthStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Corkins, MD, Principal investigator, Le Bonheur Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583673
- Sponsor's protocol ID
- 09.56.PED
- Status last verified
- Jun 2014
- First submitted
- 20 Apr 2012
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PubMed 33006765
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Growth of Infants Fed an Amino Acid Based Formula
- ClinicalTrials.gov ID
- NCT01583673
- Acronym / sponsor ID
- 09.56.PED
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Apr 2012 (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 primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new Amino Acid Formula to infants consuming a commercially available hypoallergenic formula over a period of 4 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amino Acid Formula | Experimental | Other: Amino Acid FormulaHypoallergenic baby formula |
| Amino Acid commercial formula | Active comparator | Other: Amino Acid formulaHypoallergenic commercial amino acid formula |
Who may qualify
- Ages
- Up to 17 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy newborn infant
- Full-term (>= 37 weeks gestation)
- Birth weight between >= 2500 and < =4500 g
- 0-17 days of age on enrolment (day 0 is day of birth)
- Infant's mother has elected not to breastfeed and to exclusively formula-feed infant
Key exclusion criteria (7 listed)
- Congenital illness or malformation that may affect infant feeding and/or normal growth
- Suspected or known allergy to cow's milk protein
- Significant pre-natal and/or post-natal disease
- Any readmission to hospital (except for hyperbilirubinemia) prior to enrolment
- Infant receiving prescription medication (with exception of topical antibiotics and/or treatment for thrush) or frequent use of over the counter medications except vitamin and mineral supplements
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 |
|---|---|---|
| Amino Acid FormulaSubjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula | Other | Amino Acid Formula |
| Amino Acid formulaSubjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula | Other | Amino Acid commercial formula |
Primary outcome
Weight Gain
Time frame: 4 months
Mean weight gain (g/day) from enrollment to 4 months of age
1 secondary outcome
tolerance
Time frame: 4 months
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 21 Oct 2015.
- Derived from this study: PubMed 33006765Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
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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.
Marc Corkins, MD principal investigator
Le Bonheur Children's Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amino Acid Formula in people with Growth, run by Société des Produits Nestlé (SPN) 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 7 inclusion and 7 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 21 Oct 2015. 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 Gain (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01583673, which also lists 1 linked publication.
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 21 Oct 2015.