Growth of Term InfantsNCT02132663
The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants
A study testing An investigational infant formula containing an alternate source of DHA in people with Growth of Term Infants, run by Mead Johnson Nutrition at 22 sites in United States.
Trial summary
This clinical trial will evaluate an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant formula. Read more about this study
- Who is it for?
- Ages 10 to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Growth of Term Infants
- What is being tested?
- An investigational infant formula containing an alternate source of DHA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 22 sitesUnited States
- Study dates
- May 2014to Apr 2015
- 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 10 to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton, 10-14 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
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Children's Research, LLC
Altamonte Springs, Florida, 32701
Austin Diagnostic Clinic
Austin, Texas, 78745
Birmingham Pediatric Associates
Birmingham, Alabama, 35205
Greenvale Pediatrics - Hoover
Birmingham, Alabama, 35244
Cary Pediatric Center
Cary, North Carolina, 27511
Coastal Pediatric Research
Charleston, South Carolina, 29414
Pediatric Associates of Mt. Carmel, Inc
Cincinnati, Ohio, 45245
Southeastern Pediatric Association
Dothan, Alabama, 36305
Deaconess Clinical Research
Evansville, Indiana, 47725
Pediatric Associates of Fairfield, Inc.
Fairfield, Ohio, 45014
Northwest Arkansas Pediatric Clinic
Fayetteville, Arkansas, 72703
The Jackson Clinic - North Jackson
Jackson, Tennessee, 38305
The Children's Clinic of Jonesboro, P.A.
Jonesboro, Arkansas, 72401
Holston Medical Group
Kingsport, Tennessee, 37660
DCOL Center for Clinical Research
Longview, Texas, 75605
Norwich Pediatric Group, PC
Norwich, Connecticut, 06360
Owensboro Pediatrics
Owensboro, Kentucky, 42303
Pediatrics East - Alabama Clinical Therapeutics
Pinson, Alabama, 35126
Capital Pediatrics & Adolescent Center
Raleigh, North Carolina, 27609
Physician Care Clinical Research
Sarasota, Florida, 34239
UHMP Comprehensive Pediatrics
Westlake, Ohio, 44145
Woburn Pediatic Associates
Woburn, Massachusetts, 01801
About this study
This clinical trial will evaluate an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant formula.
- Conditions
- Growth of Term Infants
- Being tested
- Control: Marketed routine infant formula, An investigational infant formula containing an alternate source of DHA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control: Marketed routine infant formulaOther
An investigational infant formula containing an alternate source of DHAOther
| Study group | Role | What they receive |
|---|---|---|
| Infant formula containing an alternate source of DHA | Experimental | Not described Receives: Other: An investigational infant formula containing an alternate source of DHA |
| Marketed routine infant formula | Active comparator | Not described Receives: Other: Control: Marketed routine 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 (7)
Recall of infant formula intake at each study visit
Measured: 3.5 months
Body length measured at each study visit
Measured: 3.5 months
Recall of stool consistency measured at each study visit
Measured: 3.5 months
Medically-confirmed adverse events collected throughout the study period
Measured: 3.5 months
Head circumference measured at each study visit
Measured: 3.5 months
Recall of gastrointestinal tolerance measured at each study visit
Measured: 3.5 months
Blood Collection
Blood Collection from a subset of participants to measure levels of fatty acids such as docosahexaenoic acid (DHA) and arachidonic acid (ARA).
Measured: Once at 120 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 posted7 May 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2015
- Study completionApr 2015
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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carol Lynn Berseth, M.D., Study director, Mead Johnson and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132663
- Sponsor's protocol ID
- 3386-1
- Status last verified
- Apr 2015
- First submitted
- 5 May 2014
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Yeiser M, Harris CL, Kirchoff AL, Patterson AC, Wampler JL, Zissman EN, Berseth CL. Growth and tolerance of infants fed formula with a new algal source of docosahexaenoic acid: Double-blind, randomized, controlled trial. Prostaglandins Leukot Essent Fatty Acids. 2016 Dec;115:89-96. doi: 10.1016/j.plefa.2016.09.001. Epub 2016 Sep 29.
PubMed 27914519
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants
- ClinicalTrials.gov ID
- NCT02132663
- Acronym / sponsor ID
- 3386-1
- Conditions
- Growth of Term Infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- May 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 7 May 2014 (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 an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant formula.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infant formula containing an alternate source of DHA | Experimental | Other: An investigational infant formula containing an alternate source of DHA |
| Marketed routine infant formula | Active comparator | Other: Control: Marketed routine infant formula |
Who may qualify
- Ages
- 10 to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Singleton, 10-14 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 |
|---|---|---|
| Control: Marketed routine infant formula | Other | Marketed routine infant formula |
| An investigational infant formula containing an alternate source of DHA | Other | Infant formula containing an alternate source of DHA |
Primary outcome
Body weight measured at each study visit
Time frame: 3.5 Months
7 secondary outcomes
Recall of infant formula intake at each study visit
Time frame: 3.5 months
Body length measured at each study visit
Time frame: 3.5 months
Recall of stool consistency measured at each study visit
Time frame: 3.5 months
Medically-confirmed adverse events collected throughout the study period
Time frame: 3.5 months
Head circumference measured at each study visit
Time frame: 3.5 months
Recall of gastrointestinal tolerance measured at each study visit
Time frame: 3.5 months
Blood Collection
Time frame: Once at 120 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 1 May 2015.
- Derived from this study: PubMed 27914519Yeiser M, Harris CL, Kirchoff AL, Patterson AC, Wampler JL, Zissman EN, Berseth CL. Growth and tolerance of infants fed formula with a new algal source of docosahexaenoic acid: Double-blind, randomized, controlled trial. Prostaglandins Leukot Essent Fatty Acids. 2016 Dec;115:89-96. doi: 10.1016/j.plefa.2016.09.001. Epub 2016 Sep 29.
Related trials for Growth of Term Infants
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Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
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A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
Infant ALL
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eCPAP Follow-up at School Age
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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.
Carol Lynn Berseth, M.D. study director
Mead Johnson and Company
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An investigational infant formula containing an alternate source of DHA in people with Growth of Term Infants, run by Mead Johnson Nutrition at 22 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 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 NCT02132663, 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 1 May 2015.