Nutritive Effects on Brain MyelinationNCT04859231
Nutritive Effects of Cow's Milk-Based Formulas Through 18 Months of Age
A study testing Investigational in people with Nutritive Effects on Brain Myelination, run by Mead Johnson Nutrition at 1 site in United States.
Trial summary
This clinical trial will assess nutritive effects on brain myelination in infants assigned to receive one of two study formula or mother's own breast milk through 18 month's of age. Read more about this study
- Who is it for?
- Ages 3 to 180 daysHealthy volunteers can take part
- Conditions the study is for
- Nutritive Effects on Brain Myelination
- What is being tested?
- Investigational
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2021to 7 Sep 2021
- 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 3 to 180 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton birth
- Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
- Birth weight of 2500 g (5 lbs 8 oz) or more
- Parent(s) or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
- Signed informed consent obtained for infant's participation in the study
- Signed authorization obtained to use and/or disclose Protected Health Information for infant from birth through 18 months of age
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- Infants receiving formula:
- 3 to 60 days of age at randomization, inclusive (day of birth is considered day 0)
- Exclusively receiving infant formula for at least 72 hours prior to randomization
- Parent(s) or legal guardian has full intention to exclusively feed study formula during the study period
- Infants receiving human milk:
- 150-180 days of age at registration, inclusive (day of birth is considered day 0)
- Mother has intention to predominately provide mother's own breast milk through at least 10 months of age
Who cannot join
- Contraindication to magnetic resonance imaging (MRI)
- First degree relative with known autism, intellectual disability, schizophrenia, or bipolar disorder or an inherited disorder of myelination
- Major pre- and/or perinatal issues (such as maternal pre-eclampsia, placental abruption, maternal alcohol or illicit drug use during pregnancy)
- Major delivery complications (such as neonatal hypoxia or neonatal illness requiring a greater than 2-day NICU stay)
- Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as combined immunodeficiencies, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe congenital neutropenia and secondary immunodeficiencies linked to HIV infection, Down syndrome or others)
- 5 minute APGAR < 7
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- Infant was born large for gestational age (LGA) (as confirmed by the hospital birth records) from mother who was diabetic at childbirth
- Infant has been identified with inadequate weight gain or failure to thrive by a health care professional (HCP)
- History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant
- Parent(s) or legal guardian unable to speak English at a level to provide informed consent
- Infants receiving formula:
- Evidence of feeding difficulties or history of formula intolerance, such as vomiting or poor intake at time of randomization
- Infants receiving human milk:
- Use of infant formula and/or donor milk more than three times per week prior to registration
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
This clinical trial will assess nutritive effects on brain myelination in infants assigned to receive one of two study formula or mother's own breast milk through 18 month's of age.
- Conditions
- Nutritive Effects on Brain Myelination
- Being tested
- Control, Investigational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Cow's milk-based formula
InvestigationalOther
Cow's milk-based formula with added source of enriched whey protein
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Not described Receives: Other: Control |
| Investigational | Experimental | Not described Receives: Other: Investigational |
| Mother's-own Breast Milk | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MR Imaging
Brain Imaging
Measured: 365 days of age
Secondary outcomes (11)
MR Imaging
Brain Imaging
Measured: 180 and 545 days of age
Gap Overlap Paradigm
Measured: 180 and 365 days of age
Visual Expectation Paradigm
Measured: 180 and 365 days of age
A-not-B Task
Measured: 365 and 545 days of age
Bayley Scales of Infant and Toddler Development, Third Edition
Measured: 365 and 545 days of age
Body Weight
Measured: 180, 365 and 545 days of age
Length
Measured: 180, 365 and 545 days of age
Head Circumference
Measured: 180, 365 and 545 days of age
Recall of Study Feeding
Feeding Questionnaire
Measured: 180, 275 (HM Reference group only), 365 and 545 days of age
Stool Microbiome Composition
Sequence analysis using QIIME 2.0 (quantitative insights into microbial ecology)
Measured: 180, 365 and 545 days of age
Medically confirmed Adverse Events
Measured: Through study completion, on average 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start5 Aug 2021
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Why it stopped: Poor recruitment
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 Nutritive Effects on Brain MyelinationStudies 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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859231
- Sponsor's protocol ID
- 6042
- Status last verified
- Dec 2021
- First submitted
- 16 Apr 2021
- Last updated
- 3 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
PubMed 37929831
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritive Effects of Cow's Milk-Based Formulas Through 18 Months of Age
- ClinicalTrials.gov ID
- NCT04859231
- Acronym / sponsor ID
- 6042
- Conditions
- Nutritive Effects on Brain Myelination
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 5 Aug 2021 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 26 Apr 2021 (actual)
- 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 nutritive effects on brain myelination in infants assigned to receive one of two study formula or mother's own breast milk through 18 month's of age.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control |
| Investigational | Experimental | Other: Investigational |
| Mother's-own Breast Milk | No intervention | – |
Who may qualify
- Ages
- 3 to 180 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Singleton birth
- Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
- Birth weight of 2500 g (5 lbs 8 oz) or more
- Parent(s) or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study
- Signed informed consent obtained for infant's participation in the study
Key exclusion criteria (14 listed)
- Contraindication to magnetic resonance imaging (MRI)
- First degree relative with known autism, intellectual disability, schizophrenia, or bipolar disorder or an inherited disorder of myelination
- Major pre- and/or perinatal issues (such as maternal pre-eclampsia, placental abruption, maternal alcohol or illicit drug use during pregnancy)
- Major delivery complications (such as neonatal hypoxia or neonatal illness requiring a greater than 2-day NICU stay)
- Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as combined immunodeficiencies, DiGeorge syndrome, Wiskott-Aldrich syndrome, severe congenital neutropenia and secondary immunodeficiencies linked to HIV infection, Down syndrome or others)
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 |
|---|---|---|
| ControlCow's milk-based formula | Other | Control |
| InvestigationalCow's milk-based formula with added source of enriched whey protein | Other | Investigational |
Primary outcome
MR Imaging
Time frame: 365 days of age
Brain Imaging
11 secondary outcomes
MR Imaging
Time frame: 180 and 545 days of age
Gap Overlap Paradigm
Time frame: 180 and 365 days of age
Visual Expectation Paradigm
Time frame: 180 and 365 days of age
A-not-B Task
Time frame: 365 and 545 days of age
Bayley Scales of Infant and Toddler Development, Third Edition
Time frame: 365 and 545 days of age
Body Weight
Time frame: 180, 365 and 545 days of age
Length
Time frame: 180, 365 and 545 days of age
Head Circumference
Time frame: 180, 365 and 545 days of age
Recall of Study Feeding
Time frame: 180, 275 (HM Reference group only), 365 and 545 days of age
Stool Microbiome Composition
Time frame: 180, 365 and 545 days of age
Medically confirmed Adverse Events
Time frame: Through study completion, on average 18 months
Results and safety
The study was stopped early (reason given: Poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2022.
- Derived from this study: PubMed 37929831Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational in people with Nutritive Effects on Brain Myelination, run by Mead Johnson Nutrition at 1 site 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 13 inclusion and 14 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: stopped early, as of the sponsor's last update on 3 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Poor recruitment). Results are not available in the source record.
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?
MR Imaging (time frame: 365 days of age). 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 NCT04859231, 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 3 Jan 2022.