GrowthNCT01210391
Growth of Infants Fed an Extensively Hydrolyzed Infant Formula
A study testing Extensively hydrolyzed whey infant formula and Extensively hydrolyzed casein infant formula in people with Growth, run by Société des Produits Nestlé (SPN) at 20 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 extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF. Read more about this study
- Who is it for?
- Ages 11 days to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Growth
- What is being tested?
- Extensively hydrolyzed whey infant formula and Extensively hydrolyzed casein infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 20 sitesUnited States
- Study dates
- Nov 2010to 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 11 days to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn singleton infant
- Full-term (>= 37 weeks gestation)
- Birth weight between >= 2500 and < =4500 g
- 14 ± 3 days of age on enrollment
- Infant's mother has elected not to breastfeed
- baby has been exclusively formula fed a minimum of 3 days prior to enrollment
- Study explained and written information provided with Parent/Caregiver
- Informed consent signed (parent/legal representative)
Who cannot join
- Congenital illness or malformation affecting infant feeding and/or 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 enrollment
- Infant has received oral or IV antibiotic therapy in the 10 days prior to enrollment
- 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
Show all 9Show fewer
- Infant has received probiotics in the seven days prior to enrollment
- Infant currently participating in another clinical study
- Infant's family who in the Investigator's assessment cannot be expected to comply with the protocol
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Scott & White Wells Branch Clinic
Austin, Texas, 78728
ARK-LA-Tex Pediatric Research
Bossier City, Louisiana
Alpha Clinical Research
Clarksville, Tennessee
Colorado Springs Health Partners
Colorado Springs, Colorado
Square-1 Clinical Research
Erie, Pennsylvania
Cyn3rgy Research
Gresham, Oregon
Jackson Clinic
Jackson, Tennessee, 38305
Scott & White Killeen Clinic
Killeen, Texas, 76543
Clinical Research of Nevada
Las Vegas, Nevada
Tanner Clinic
Layton, Utah
DCOL Center for Research
Longview, Texas
Institute of Clinical Research
Mayfield Heights, Ohio
The Clinical Trials Center
New Orleans, Louisiana, 70118
Pedia Research
Newburgh, Indiana, 42301
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Pedia Research
Owensboro, Kentucky, 42301
Clinical Research Partners
Richmond, Virginia
Southwest Children's Research Associates
San Antonio, Texas, 78229
Scott & White Temple
Temple, Texas, 76508
Wenatchee Valley Medical Center
Wenatchee, Washington
About this study
Official title: Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.
The primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.
- Conditions
- Growth
- Being tested
- Extensively hydrolyzed whey infant formula, Extensively hydrolyzed casein infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extensively hydrolyzed whey infant formulaOther
Also called Baby Formula
New hydrolyzed infant formula.
Extensively hydrolyzed casein infant formulaOther
Also called Baby Formula
Commercially available infant formula.
| Study group | Role | What they receive |
|---|---|---|
| New hydrolyzed infant formula | Experimental | New, extensively hydrolyzed infant formula Receives: Other: Extensively hydrolyzed whey infant formula |
| Commercially available infant formula | Active comparator | Commercially available, extensively hydrolyzed infant formula. Receives: Other: Extensively hydrolyzed casein infant 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionJul 2013
- Study completionJul 2013
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.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ricardo Sorensen, MD, Principal investigator, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210391
- Sponsor's protocol ID
- 09.43.PED
- Status last verified
- Jun 2014
- First submitted
- 27 Sep 2010
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Growth of Infants Fed a 100% Whey Extensively Hydrolyzed Formula.
- ClinicalTrials.gov ID
- NCT01210391
- Acronym / sponsor ID
- 09.43.PED
- Conditions
- Growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 Sep 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 primary objective of the clinical trial is to compare growth in infants (expressed as weight gain in g/day) consuming a new extensively hydrolyzed formula (EHF) to infants consuming a commercially available EHF.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New hydrolyzed infant formula | Experimental | Other: Extensively hydrolyzed whey infant formulaNew, extensively hydrolyzed infant formula |
| Commercially available infant formula | Active comparator | Other: Extensively hydrolyzed casein infant formulaCommercially available, extensively hydrolyzed infant formula. |
Who may qualify
- Ages
- 11 days to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Healthy newborn singleton infant
- Full-term (>= 37 weeks gestation)
- Birth weight between >= 2500 and < =4500 g
- 14 ± 3 days of age on enrollment
- Infant's mother has elected not to breastfeed
Key exclusion criteria (9 listed)
- Congenital illness or malformation affecting infant feeding and/or 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 enrollment
- Infant has received oral or IV antibiotic therapy in the 10 days 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 |
|---|---|---|
| Extensively hydrolyzed whey infant formulaAlso: Baby FormulaNew hydrolyzed infant formula. | Other | New hydrolyzed infant formula |
| Extensively hydrolyzed casein infant formulaAlso: Baby FormulaCommercially available infant formula. | Other | Commercially available infant formula |
Primary outcome
Weight Gain
Time frame: 4 Months
Mean weight gain (g/day) from enrollment to 4 months 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 26 Jun 2014.
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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.
Ricardo Sorensen, MD principal investigator
Louisiana State University Health Sciences Center in New Orleans
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extensively hydrolyzed whey infant formula and Extensively hydrolyzed casein infant formula in people with Growth, run by Société des Produits Nestlé (SPN) 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 9 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 26 Jun 2014. 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.
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?
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 26 Jun 2014.