Body WeightNCT01122654
Growth and Tolerance of Cow Milk-Based Infant Formulas
An observational study of Body Weight, run by Mead Johnson Nutrition at 24 sites in United States.
Trial summary
This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants. Read more about this study
- Who is it for?
- Ages 12 to 16 daysHealthy volunteers can take part
- Conditions the study is for
- Body Weight
- How many people
- 405 participants
- Where
- 24 sitesUnited States
- Study dates
- Jul 2010to Dec 2011
- 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: Healthy, term infants
Who may be able to join
- Singleton, 12-16 days of age at randomization
- Term infant with birth weight of minimum of 2500 g
- Solely formula fed
- Signed Informed Consent and Protected Health Information
Who cannot join
- History of underlying metabolic or chronic disease or immunocompromised
- Acute infection
- 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
Cary Pediatric Center, PA
Cary, North Carolina, 27511
Alpha Clinical Research
Clarksville, Tennessee, 37043
North Georgia Clinical Research Center/White's Pediatrics
Dalton, Georgia, 30721
Southeastern Pediatric Associates
Dothan, Alabama, 36305
Innovis Health South University
Fargo, North Dakota, 58103
The Jackson Clinic - North Jackson
Jackson, Tennessee, 38305
Holston Medical Group
Kingsport, Tennessee, 37660
Altamonte Pediatric Associates
Lake Mary, Florida, 32746
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205
PTCU/Children & Youth Project
Louisville, Kentucky, 40202
Deaconess Clinic Gateway
Newburgh, Indiana, 47630
Southwestern Medical Clinic, PC
Niles, Michigan, 49120
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360
The Center for Human 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
Southwestern Medical Clinic P.C.
Stevensville, Michigan, 49127
Woburn Pediatric Associates
Woburn, Massachusetts, 01801
About this study
This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.
- Conditions
- Body Weight
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described | |
| Experimental 1 | Not described | |
| Experimental 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight measured on calibrated infant scale at each study visit
Secondary outcomes (5)
Twenty-four hour recall of infant formula intake at each study visit
Medically-confirmed adverse events collected throughout the study period
Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit
Parental Product Assessment Questionnaire completed at Study Visit 2
Assessment of physical properties of product and infant's reaction during consumption.
Body Length and Head Circumference measured at each study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2011
- Study completionDec 2011
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 Body WeightStudies 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
- 405 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122654
- Sponsor's protocol ID
- 3380-1
- Status last verified
- Jan 2012
- First submitted
- 10 May 2010
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Johnston WH, Ashley C, Yeiser M, Harris CL, Stolz SI, Wampler JL, Wittke A, Cooper TR. Growth and tolerance of formula with lactoferrin in infants through one year of age: double-blind, randomized, controlled trial. BMC Pediatr. 2015 Nov 7;15:173. doi: 10.1186/s12887-015-0488-3.
PubMed 26547414
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Tolerance of Cow Milk-Based Infant Formulas
- ClinicalTrials.gov ID
- NCT01122654
- Acronym / sponsor ID
- 3380-1
- Conditions
- Body Weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 13 May 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.
This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | – |
| Experimental 1 | – | – |
| Experimental 2 | – | – |
Who may qualify
- Ages
- 12 to 16 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy, term infants
Key inclusion criteria (4 listed)
- Singleton, 12-16 days of age at randomization
- Term infant with birth weight of minimum of 2500 g
- Solely formula fed
- Signed Informed Consent and Protected Health Information
Key exclusion criteria (3 listed)
- History of underlying metabolic or chronic disease or immunocompromised
- Acute infection
- 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.
Primary outcome
Body weight measured on calibrated infant scale at each study visit
5 secondary outcomes
Twenty-four hour recall of infant formula intake at each study visit
Medically-confirmed adverse events collected throughout the study period
Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit
Parental Product Assessment Questionnaire completed at Study Visit 2
Body Length and Head Circumference measured at each study visit
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 31 Jan 2012.
- Derived from this study: PubMed 26547414Johnston WH, Ashley C, Yeiser M, Harris CL, Stolz SI, Wampler JL, Wittke A, Cooper TR. Growth and tolerance of formula with lactoferrin in infants through one year of age: double-blind, randomized, controlled trial. BMC Pediatr. 2015 Nov 7;15:173. doi: 10.1186/s12887-015-0488-3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Body Weight, 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 3 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 31 Jan 2012. 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 on calibrated infant scale at each study visit. 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 NCT01122654, 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 31 Jan 2012.