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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
240
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.
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.
Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.
Jinhua Nanyuan Community Health Center (site 1919)
Jinhua, Zhejiang, China
Li Pu Community Hospital
Jinhua, Zhejiang, China
Qiu Bin Community Hospital
Jinhua, Zhejiang, China
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.
Time frame: At the age of 12 months
Weight in grams
The weight measurement (gram) of the participant for each site visit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: baseline day to 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.