The goal of this interventional clinical trial is to test the effectiveness of enhancing immunity in newly born infants fed with Feihe investigational formula product containing Lactoferrin fortified with HMO. The main question it aims to answer is: \- whether the immunity functions of participants in terms of frequency of catching flu and cold 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 primary outcome - frequency of catching flu and cold for each visit interval, 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 Lactoferrin fortified with HMO will improve immunity 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 Feihe 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
Jinhua, Zhejiang, China
Li Pu Community Hospital
Jinhua, Zhejiang, China
Qiu Bin Community Hospital
Jinhua, Zhejiang, China
Frequency of flu and cold during the study
Frequency of flu and cold that participants caught during the study, which has positive relationship with immunology outcomes.
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
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