Improved Cognitive Outcomes Associated With Feihe HMO With DHA/ARA in Infant Formula
NCT ID: NCT06146387
Last Updated: 2023-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
240 participants
INTERVENTIONAL
2023-11-14
2025-04-30
Brief Summary
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\- 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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Investigational Formula
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
Investigational Formula
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 Formula
Control formula contains comparable macronutrients and micronutrients, but does not contain HMO, DHA and ARA.
Control Formula
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.
Breastfeeding
breastmilk-feeding
Breastfeeding
Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.
Interventions
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Investigational Formula
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 Formula
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.
Breastfeeding
Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.
Eligibility Criteria
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Inclusion Criteria
* Exclusively formula for at least 3 days fed prior to onset of study period.
* 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.) or more.
* 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.
Exclusion Criteria
* 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 and during the study.
1 Day
28 Days
ALL
Yes
Sponsors
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Heilongjiang Feihe Dairy Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Charlie Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
SPRIM Medical
Locations
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Kaitai Scientific Lab
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Charlie Zhang, MD
Role: primary
Other Identifiers
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22-SM-11-FEIHE-001
Identifier Type: -
Identifier Source: org_study_id