Cognitive ChangeNCT06146387

Improved Cognitive Outcomes Associated With Feihe HMO With DHA/ARA in Infant Formula

A study testing Investigational Formula and Breastfeeding in people with Cognitive Change, run by Heilongjiang Feihe Dairy Co. Ltd. at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this interventional clinical trial is to test the effectiveness of improving cognitive development in newly born infants fed with Feihe investigational formula product containing HMO, and DHA/ARA. Read more about this study

Who is it for?: Ages 1 day to 28 daysHealthy volunteers can take part
Conditions the study is for: Cognitive Change
What is being tested?: Investigational Formula and Breastfeeding
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 3 sitesChina
Study dates: 14 Nov 2023to 3 Apr 2025
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 1 day to 28 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Newborn baby, study entry before weaning (within 28 days of birth)
Exclusively formula fed for at least 3 days prior to study entry and plan to be exclusively formula fed during the study (formula groups) OR plan to be exclusively fed with human milk during the study (breastfeeding group).
Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age).
Birth weight of 2500g (5 lbs. 8 oz.) to 4200g (9 lbs. 4 oz.).
Signed informed consent obtained for infant's participation in the study.
Parent or guardian of the infant agrees to not enroll the infant in another interventional clinical research study while participating in this study.

Who cannot join

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.
Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion).
Evidence of growth problems or concern for growth.
Infant was born large for gestational age (LGA) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by Feihe) from mother who was diabetic at childbirth.
Participant 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) and children with known head/brain disease/injury.
Use of probiotics/prebiotics before the study.

Trial locations and contacts

3 sites in 1 country.

China3 sites

Jinhua Nanyuan Community Health Center (site 1919)
Jinhua, Zhejiang
Li Pu Community Hospital
Jinhua, Zhejiang
Qiu Bin Community Hospital
Jinhua, Zhejiang

Other trials in China

About this study

Official title: Improved Cognitive Outcomes Associated With Feihe HMO With DHA/ARA in Infant Formula: A Randomized, Controlled Trial

whether the score of Bayley-III cognitive scale (tested at the age of 12 months) of participants in the study product arm is significantly better than participants assigned in the other two arms.

240 qualified participants will be randomized to 3 arms (investigational formula, control formula, and breast-feeding) to consume assigned formula or breast-feeding for 12 months according to protocol. There will be up to 6 site visits arranged for each participant during the study, and all relevant clinical and questionnaire data, including the most important Barley-III cognitive scale data at the age of 12 months, will be captured, recorded and entered to CMTS (Clinical Management Trial System) for statistical analysis and reporting.

Researchers will compare the three arms to validate the assumption that the consumption of Feihe investigational formula product containing HMO, and DHA/ARA will improve cognitive development in newly born infants, along with physical development.

Conditions: Cognitive Change
Being tested: Investigational Formula, Control Formula, Breastfeeding
Keywords: Bayley-III Cognitive Scale, Feihe Infant Formula, HMO (Human Milk Oligosaccharides), DHA (Dehydroascorbic Acid), ARA (Arachidonic Acid)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Investigational FormulaDietary supplement
Participants in this arm will receive stage 1 and stage 2 investigational formulas. At the first (up to) 6 months, they will be fed with stage1 formula, and then switch to stage 2 formula until 12 months.
Control FormulaDietary supplement
Participants in this arm will receive stage 1 and stage 2 Control formulas. At the first (up to) 6 months, they will be fed with stage1 formula, and then switch to stage 2 formula until 12 months.
BreastfeedingDietary supplement
Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.

Study groups in NCT06146387
Study group	Role	What they receive
Investigational Formula	Experimental	Feihe Investigational Formula 1. Contains 2 kinds of HMOs 2. 5 kinds of phospholipid content reached the level of breast milk 3. DHA\&ARA reaches the content and proportion of breast milk in China 4. Comprehensive nutrition: OPO, probiotics, lactoferrin, CPP, nucleotide, choline, inositol, taurine, L-carnitine, GOS, lutein Receives: Dietary Supplement: Investigational Formula
Control Formula	Active comparator	Control formula contains comparable macronutrients and micronutrients, but does not contain HMO, DHA and ARA. Receives: Dietary Supplement: Control Formula
Breastfeeding	Other	breastmilk-feeding Receives: Dietary Supplement: Breastfeeding

What is being measured

The primary outcome is the main question the study is designed to answer.

Bayley-III cognitive scale
Cognitive Scale of the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is used to evaluate the cognitive development level of participants at the age of 12 months.
Bayley-III contains two scoring systems of composite scores and percentile ranks. The normal range for composite scores is between 40-160 with mean at 100 and 0-99 for the percentile ranks.
Higher scores mean a better outcome.
Measured: At the age of 12 months

Secondary outcomes (6)

Weight in grams
The weight measurement (gram) of the participant for each site visit
Measured: At the age of 15-28 days and 3, 6, 9, 12 months
Height in cm
The height measurement (cm) of the participant for each site visit
Measured: At the age of 15-28 days and 3, 6, 9, 12 months
Head circumference in cm
The head circumference measurement (cm) of the participant for each site visit
Measured: At the age of 15-28 days and 3, 6, 9, 12 months
Amount of formula intake in ml
The 24-Hour dietary recall of Formula intake (amount in ml of study formula, any other infant formula or milk consumed) of the participant for each site visit
Measured: At the age of 15-28 days and 3, 6, 9, 12 months
Stool Characteristics Questionnaire
The frequency of bowel movements and the rating score (0-5) of the stool consistency over the 24-hour period. The rating score of the stool consistency from the stool picture:
(0) No bowel movement;
1. Hard- dry, hard pellets;
2. Formed- definite shape, not dry;
3. Soft-no definite shape, pasty;
4. Unformed or seedy- no shape, some water or small lumps ;
5. Waterly- no shape, mainly water where the score of 0-1 represents poor stool characteristics, while 2-5 represents fine stool characteristics.
Measured: At the age of 15-28 days and 3, 6 months
Medically-confirmed adverse events
The frequency of medically-confirmed adverse events occurred during the study
Measured: baseline day to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Nov 20233 Apr 2025

First posted24 Nov 2023
Study start14 Nov 2023
Primary completion3 Apr 2025
Study completion3 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cognitive ChangeStudies 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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06146387
Sponsor's protocol ID: 22-SM-11-FEIHE-001
Status last verified: Dec 2025
First submitted: 19 Nov 2023
Last updated: 8 Dec 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improved Cognitive Outcomes Associated With Feihe HMO With DHA/ARA in Infant Formula: A Randomized, Controlled Trial
ClinicalTrials.gov ID: NCT06146387
Acronym / sponsor ID: 22-SM-11-FEIHE-001
Conditions: Cognitive Change
Keywords: Bayley-III Cognitive Scale, Feihe Infant Formula, HMO (Human Milk Oligosaccharides), DHA (Dehydroascorbic Acid), ARA (Arachidonic Acid)
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Heilongjiang Feihe Dairy Co. Ltd.Industry (pharma, biotech, devices)
Study start: 14 Nov 2023 (actual)
Primary completion: 3 Apr 2025 (actual)
Study completion: 3 Apr 2025 (actual)
First posted: 24 Nov 2023 (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.

whether the score of Bayley-III cognitive scale (tested at the age of 12 months) of participants in the study product arm is significantly better than participants assigned in the other two arms.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Investigational Formula	Experimental	Dietary Supplement: Investigational FormulaFeihe Investigational Formula 1. Contains 2 kinds of HMOs 2. 5 kinds of phospholipid content reached the level of breast milk 3. DHA\&ARA reaches the content and proportion of breast milk in China 4. Comprehensive nutrition: OPO, probiotics, lactoferrin, CPP, nucleotide, choline, inositol, taurine, L-carnitine, GOS, lutein
Control Formula	Active comparator	Dietary Supplement: Control FormulaControl formula contains comparable macronutrients and micronutrients, but does not contain HMO, DHA and ARA.
Breastfeeding	Other	Dietary Supplement: Breastfeedingbreastmilk-feeding

Who may qualify

Ages: 1 day to 28 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Newborn baby, study entry before weaning (within 28 days of birth)
Exclusively formula fed for at least 3 days prior to study entry and plan to be exclusively formula fed during the study (formula groups) OR plan to be exclusively fed with human milk during the study (breastfeeding group).
Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age).
Birth weight of 2500g (5 lbs. 8 oz.) to 4200g (9 lbs. 4 oz.).
Signed informed consent obtained for infant's participation in the study.

Key exclusion criteria (6 listed)

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.
Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion).
Evidence of growth problems or concern for growth.
Infant was born large for gestational age (LGA) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by Feihe) from mother who was diabetic at childbirth.
Participant 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) and children with known head/brain disease/injury.

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
Investigational FormulaParticipants in this arm will receive stage 1 and stage 2 investigational formulas. At the first (up to) 6 months, they will be fed with stage1 formula, and then switch to stage 2 formula until 12 months.	Dietary supplement	Investigational Formula
Control FormulaParticipants in this arm will receive stage 1 and stage 2 Control formulas. At the first (up to) 6 months, they will be fed with stage1 formula, and then switch to stage 2 formula until 12 months.	Dietary supplement	Control Formula
BreastfeedingExclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.	Dietary supplement	Breastfeeding

Primary outcome

Bayley-III cognitive scale
Time frame: At the age of 12 months
Cognitive Scale of the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is used to evaluate the cognitive development level of participants at the age of 12 months. Bayley-III contains two scoring systems of composite scores and percentile ranks. The normal range for composite scores is between 40-160 with mean at 100 and 0-99 for the percentile ranks. Higher scores mean a better outcome.

6 secondary outcomes

Weight in grams
Time frame: At the age of 15-28 days and 3, 6, 9, 12 months
Height in cm
Time frame: At the age of 15-28 days and 3, 6, 9, 12 months
Head circumference in cm
Time frame: At the age of 15-28 days and 3, 6, 9, 12 months
Amount of formula intake in ml
Time frame: At the age of 15-28 days and 3, 6, 9, 12 months
Stool Characteristics Questionnaire
Time frame: At the age of 15-28 days and 3, 6 months
Medically-confirmed adverse events
Time frame: baseline day to 12 months

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 8 Dec 2025.

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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.

Yajun Xu, MD principal investigator

Peking University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Investigational Formula and Breastfeeding in people with Cognitive Change, run by Heilongjiang Feihe Dairy Co. Ltd. at 3 sites 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 6 inclusion and 6 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 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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?

Bayley-III cognitive scale (time frame: At the age of 12 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 NCT06146387.

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 8 Dec 2025.