Cognitive Ability, GeneralNCT04442477
Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
An observational study of Cognitive Ability, General, run by Mead Johnson Nutrition at 1 site in China.
Trial summary
This is a follow-up study of a multi-center, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate neurodevelopment at 5.5 years of age and health outcomes through 5.5 years of age in participants who received one of two staged study formulas through one year of age. Read more about this study
- Who is it for?
- Ages 64 to 68 monthsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Ability, General
- What is being tested?
- Enriched Protein Fractions and Protein Fraction
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2020to 27 May 2021
- 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 64 to 68 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants who previously consumed study formula through one year of age in MJN Project 6027.
Who may be able to join
- Participant who previously consumed study formula through one year of age in MJN Project 6027
- 5.5 years of age (i.e. when child turns 5 years and 6 months old ± 2 months) at Visit 1
- Signed informed consent obtained for child's participation in the study
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
This is a follow-up study of a multi-center, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate neurodevelopment at 5.5 years of age and health outcomes through 5.5 years of age in participants who received one of two staged study formulas through one year of age.
- Conditions
- Cognitive Ability, General
- Being tested
- Enriched Protein Fractions, Protein Fraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enriched Protein FractionsDietary supplement
Enriched protein fractions
Protein FractionDietary supplement
Protein fractions
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Enriched Protein Fractions | This group was given Infant formula with enriched protein fractions Receives: Dietary Supplement: Enriched Protein Fractions | |
| Active Comparator: Protein Fractions | This group was given Infant formula with protein fractions Receives: Dietary Supplement: Protein Fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV)
Measured: At 5.5 years of age
Secondary outcomes (7)
Dimensional Change Card Sort (DCCS)
Measured: At 5.5 years of age
Stroop Task
Measured: At 5.5 years of age
Functional Near Infrared Spectroscopy (fNIRS)
Measured: At 5.5 years of age
Child Behavior Checklist (CBCL)
Measured: At 5.5 years of age
Body weight
Measured: At 5.5 years of age
Body height
Measured: At 5.5 year of age
Health history outcomes
Measured: At 5.5 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start15 Jun 2020
- Primary completion27 May 2021
- Study completion27 May 2021
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 Cognitive Ability, GeneralStudies 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
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mead Johnson Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fei Li, Principal investigator, Shanghai Children's Medical CenterSteven Wu, M.D., Study director, Mead Johnson/RB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04442477
- Sponsor's protocol ID
- 6027-2
- Status last verified
- Dec 2021
- First submitted
- 18 Jun 2020
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colombo J, Harris CL, Wampler JL, Zhuang W, Shaddy DJ, Liu BY, Wu SS. Improved Neurodevelopmental Outcomes at 5.5 Years of Age in Children Who Received Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula Through 12 Months: A Randomized Controlled Trial. J Pediatr. 2023 Oct;261:113483. doi: 10.1016/j.jpeds.2023.113483. Epub 2023 May 14.
PubMed 37192722
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopment at 5.5 Years of Age in Children Who Received Infant Formula With Enriched Protein Fractions
- ClinicalTrials.gov ID
- NCT04442477
- Acronym / sponsor ID
- 6027-2
- Conditions
- Cognitive Ability, General
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Mead Johnson NutritionIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 22 Jun 2020 (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 is a follow-up study of a multi-center, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate neurodevelopment at 5.5 years of age and health outcomes through 5.5 years of age in participants who received one of two staged study formulas through one year of age.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Enriched Protein Fractions | – | Dietary Supplement: Enriched Protein FractionsThis group was given Infant formula with enriched protein fractions |
| Active Comparator: Protein Fractions | – | Dietary Supplement: Protein FractionThis group was given Infant formula with protein fractions |
Who may qualify
- Ages
- 64 to 68 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants who previously consumed study formula through one year of age in MJN Project 6027.
Key inclusion criteria (3 listed)
- Participant who previously consumed study formula through one year of age in MJN Project 6027
- 5.5 years of age (i.e. when child turns 5 years and 6 months old ± 2 months) at Visit 1
- Signed informed consent obtained for child's participation in the study
Key exclusion criteria (1 listed)
- No exclusion criteria
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 |
|---|---|---|
| Enriched Protein FractionsEnriched protein fractions | Dietary supplement | Experimental: Enriched Protein Fractions |
| Protein FractionProtein fractions | Dietary supplement | Active Comparator: Protein Fractions |
Primary outcome
Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV)
Time frame: At 5.5 years of age
7 secondary outcomes
Dimensional Change Card Sort (DCCS)
Time frame: At 5.5 years of age
Stroop Task
Time frame: At 5.5 years of age
Functional Near Infrared Spectroscopy (fNIRS)
Time frame: At 5.5 years of age
Child Behavior Checklist (CBCL)
Time frame: At 5.5 years of age
Body weight
Time frame: At 5.5 years of age
Body height
Time frame: At 5.5 year of age
Health history outcomes
Time frame: At 5.5 years 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 16 Dec 2021.
- Derived from this study: PubMed 37192722Colombo J, Harris CL, Wampler JL, Zhuang W, Shaddy DJ, Liu BY, Wu SS. Improved Neurodevelopmental Outcomes at 5.5 Years of Age in Children Who Received Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula Through 12 Months: A Randomized Controlled Trial. J Pediatr. 2023 Oct;261:113483. doi: 10.1016/j.jpeds.2023.113483. Epub 2023 May 14.
- Individual participant dataSharing planned: No
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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.
Fei Li principal investigator
Shanghai Children's Medical Center
Steven Wu, M.D. study director
Mead Johnson/RB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Ability, General, run by Mead Johnson Nutrition at 1 site in China.
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 3 inclusion and 1 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 16 Dec 2021. 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 China. 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?
Wechsler Preschool & Primary Scale of Intelligence™ (Fourth Edition; WPPSI™-IV) (time frame: At 5.5 years 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 NCT04442477, 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 16 Dec 2021.