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

Study Overview
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Brief Summary
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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. The main question it aims to answer is: - 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.

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

Conditions
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Cognitive Change

Intervention / Treatment
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* Dietary Supplement: Investigational Formula
* Dietary Supplement: Control Formula
* Dietary Supplement: Breastfeeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Newborn baby, study entry before weaning (within 28 days of birth) 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: 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 and during the study.

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Formula<br>Feihe Investigational Formula Contains 2 kinds of HMOs 5 kinds of phospholipid content reached the level of breast milk DHA&ARA reaches the content and proportion of breast milk in China Comprehensive nutrition: OPO, probiotics, lactoferrin, CPP, nucleotide, choline, inositol, taurine, L-carnitine, GOS, lutein | Dietary Supplement: Investigational Formula<br>* 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.<br>|
| Active Comparator: Control Formula<br>Control formula contains comparable macronutrients and micronutrients, but does not contain HMO, DHA and ARA. | Dietary Supplement: Control Formula<br>* 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.<br>|
| Other: Breastfeeding<br>breastmilk-feeding | Dietary Supplement: Breastfeeding<br>* Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the age of 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight in grams | The weight measurement (gram) of the participant for each site visit | 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 | 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 | 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 | 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; Hard- dry, hard pellets; Formed- definite shape, not dry; Soft-no definite shape, pasty; Unformed or seedy- no shape, some water or small lumps ; Waterly- no shape, mainly water where the score of 0-1 represents poor stool characteristics, while 2-5 represents fine stool characteristics. | 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 | baseline day to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bayley-III Cognitive Scale, Feihe Infant Formula, HMO (Human Milk Oligosaccharides), DHA (Dehydroascorbic Acid), ARA (Arachidonic Acid)