Growth of Term InfantsNCT01354366
Growth and Tolerance of Hypoallergenic Formulas
An observational study of Growth of Term Infants, run by Mead Johnson Nutrition at 24 sites in United States.
Trial summary
This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula. Read more about this study
- Who is it for?
- Ages 12 to 16 daysHealthy volunteers can take part
- Conditions the study is for
- Growth of Term Infants
- What is being tested?
- Infant formula
- How many people
- 511 participants
- Where
- 24 sitesUnited States
- Study dates
- Jul 2011to Dec 2012
- Phase
- Observational
- 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 12 to 16 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Heatly, term infants
Who may be able to join
- Singleton, 12-16 days of age at randomization
- Term infant with birth weight of a minimum of 2500 grams
- Solely formula fed
- Signed Informed Consent and Protected Health Information
Who cannot join
- History of underlying metabolic or chronic disease or immunocompromised
- Feeding difficulties or formula intolerance
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Austin Diagnostic Clinic
Austin, Texas, 78745
Central Arkansas Pediatric Clinic
Benton, Arkansas, 72019
Birmingham Pediatric Associates
Birmingham, Alabama, 35205
Pediatric Associates of Mt. Carmel, Inc
Cincinnati, Ohio, 45245
North Georgia Clinical Research Center/White's Pediatrics
Dalton, Georgia, 30721
Southeastern Pediatric Associates
Dothan, Alabama, 36305
Pediatric Associates of Fairfield, Inc
Fairfield, Ohio, 45014
Innovis Health South University
Fargo, North Dakota, 58103
The Jackson Clinic - North Jackson
Jackson, Tennessee, 38305
The Children's Clinic of Jonesboro
Jonesboro, Arkansas, 72401
Holston Medical Group
Kingsport, Tennessee, 37660
Altamonte Pediatric Associates
Lake Mary, Florida, 32746
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205
PTCU/Children and Youth Project
Louisville, Kentucky, 40202
Deaconess Clinic
Newburgh, Indiana, 47630
Norwich Pediatric Group, P.C.
Norwich, Connecticut, 06360
Gretchen Swanson Center for Nutrition
Omaha, Nebraska, 68105
Owensboro Pediatrics
Owensboro, Kentucky, 42303
Red Lion Pediatrics
Philadelphia, Pennsylvania, 19114
Pediatrics East - Alabama Clinical Therapeutics
Pinson, Alabama, 35126
Primary Physicians Research, Inc
Pittsburgh, Pennsylvania, 15241
Children's Medical Association
Plantation, Florida, 33324
Capital Pediatrics & Adolescent Center
Raleigh, North Carolina, 27609
Woburn Pediatric Associates
Woburn, Massachusetts, 01801
About this study
Official title: The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants
This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.
- Conditions
- Growth of Term Infants
- Being tested
- Infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infant formulaOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Marketed hypoallergenic infant formula containing a probiotic Receives: Other: Infant formula | |
| Experimental 1 | An investigational hypoallergenic infant formula with a different protein content, containing the same probiotic as the control Receives: Other: Infant formula | |
| Experimental 2 | An investigational hypoallergenic infant formula with a different protein content, without a probiotic Receives: Other: Infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight measured at each study visit
Measured: 3.5 months
Secondary outcomes (5)
Recall of infant formula intake at each study visit
Measured: 3.5 months
Body Length and Head Circumference measured at each study visit
Measured: 3.5 months
Recall of stool characteristics and tolerance at each study visit
Measured: 3.5 months
Medically-confirmed adverse events collected throughout the study period
Measured: 3.5 months
Parental Product Assessment Questionnaire completed at Study Visit 2
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2012
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 Growth of Term InfantsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 511 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Timothy Cooper, M.D., Study director, Mead Johnson Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354366
- Sponsor's protocol ID
- 3383-1
- Status last verified
- Aug 2013
- First submitted
- 13 May 2011
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Adams CB, Johnston WH, Deulofeut H, Leader J, Rhodes R, Yeiser M, Harris CL, Wampler JL, Hill RJ, Cooper T. Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial. BMC Pediatr. 2021 Jul 21;21(1):323. doi: 10.1186/s12887-021-02617-z.
PubMed 34289820
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants
- ClinicalTrials.gov ID
- NCT01354366
- Acronym / sponsor ID
- 3383-1
- Conditions
- Growth of Term Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 511 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 16 May 2011 (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.
This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Other: Infant formulaMarketed hypoallergenic infant formula containing a probiotic |
| Experimental 1 | – | Other: Infant formulaAn investigational hypoallergenic infant formula with a different protein content, containing the same probiotic as the control |
| Experimental 2 | – | Other: Infant formulaAn investigational hypoallergenic infant formula with a different protein content, without a probiotic |
Who may qualify
- Ages
- 12 to 16 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Heatly, term infants
Key inclusion criteria (4 listed)
- Singleton, 12-16 days of age at randomization
- Term infant with birth weight of a minimum of 2500 grams
- Solely formula fed
- Signed Informed Consent and Protected Health Information
Key exclusion criteria (2 listed)
- History of underlying metabolic or chronic disease or immunocompromised
- Feeding difficulties or formula intolerance
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 |
|---|---|---|
| Infant formula | Other | Control, Experimental 1, Experimental 2 |
Primary outcome
Body weight measured at each study visit
Time frame: 3.5 months
5 secondary outcomes
Recall of infant formula intake at each study visit
Time frame: 3.5 months
Body Length and Head Circumference measured at each study visit
Time frame: 3.5 months
Recall of stool characteristics and tolerance at each study visit
Time frame: 3.5 months
Medically-confirmed adverse events collected throughout the study period
Time frame: 3.5 months
Parental Product Assessment Questionnaire completed at Study Visit 2
Time frame: once
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 29 Aug 2013.
- Derived from this study: PubMed 34289820Adams CB, Johnston WH, Deulofeut H, Leader J, Rhodes R, Yeiser M, Harris CL, Wampler JL, Hill RJ, Cooper T. Growth and tolerance of healthy, term infants fed lower protein extensively hydrolyzed or amino acid-based formula: double-blind, randomized, controlled trial. BMC Pediatr. 2021 Jul 21;21(1):323. doi: 10.1186/s12887-021-02617-z.
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.
Timothy Cooper, M.D. study director
Mead Johnson Nutrition
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth of Term Infants, run by Mead Johnson Nutrition at 24 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 4 inclusion and 2 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 29 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
Body weight measured at each study visit (time frame: 3.5 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 NCT01354366, 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 29 Aug 2013; AzTrials last refreshed its copy on 6 Nov 2026.