This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the nutritive effects of two staged study formulas on growth and cognitive outcomes. Approximately 450 participants will be enrolled with the expectation of having 105 participants per group (315 for three groups: control group, investigational group, and breastfeeding reference group ) complete Study Visit 6 at 365 days of age ± 7 days (allowing for a 30% drop-out rate). Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age. The study period will include feeding up to 365 days of age and cognitive testing up to 365 days of age. Stool samples will be collected from a subset of participants at enrollment and at 120 days of age for fecal microbiome analysis.
Primary Objective * Compare measures of normal, healthy mental development at 365 days of age among infants receiving an investigational formula, infants receiving the control and breastfed group. Secondary Objectives To compare between the two study groups: * Measures of mental development up to 365 days of age * Rate of body weight, length and head circumference gain * Achieved weight, length and head circumference * Stool characteristics, tolerance and formula acceptance * Fecal microbiome analysis * Antibiotic treatment * Medically-confirmed adverse
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
450
Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age.
Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age.
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
RECRUITINGJinhua Qiubin Community Health Center (site 1969)
Jinhua, Zhejiang, China
RECRUITINGJinhua Xiguan Community Health Center (site 1966)
Jinhua, Zhejiang, China
RECRUITINGInfant cognitive development
Cognitive Scale of the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is used to evaluate infant cognitive development at 365 days of age. 1. Unabbreviated scale title： Bayley-III Scales of Infant Development Tables and Graphs Report-- Cognitive Scale ； 2. 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. 3. Higher scores mean a better outcome.
Time frame: at 365 days of age
Infant Language capabilities
Language Scale of Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is used to evaluate the infant Language capabilities at 365 days of age. 1. Unabbreviated scale title：Bayley-III Scales of Infant Development Tables and Graphs Report-- Language Scale ； 2. 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. 3. Higher scores mean a better outcome.
Time frame: at 365 days of age
Infant motor skills
Motor Scale of Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is used to evaluate the infant motor skills at 365 days of age. 1. Unabbreviated scale title：Bayley-III Scales of Infant Development Tables and Graphs Report-- Motor Scale 2. 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. 3. Higher scores mean a better outcome.
Time frame: at 365 days of age
Infant social-emotional capabilities
Social-emotional Scale of Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is used to evaluate the infant social-emotional capabilities at 365 days of age. 1. Unabbreviated scale title：Bayley-III Scales of Infant Development Tables and Graphs Report-- Social-emotional Scale. 2. 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. 3. Higher scores mean a better outcome.
Time frame: at 365 days of age
Infant adaptive behavior tests
Adaptive behavior Scale of Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) is used as the infant adaptive behavior assessment tool at 365 days of age. 1. Unabbreviated scale title：Bayley-III Scales of Infant Development Tables and Graphs Report-- Adaptive behavior scale 2. 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. 3. Higher scores mean a better outcome.
Time frame: at 365 days of age
Ages and Stages Questionnaires (ASQ)
Ages and Stages Questionnaires (ASQ) is administered at 120, 180, and 275 days of age. ASQ is a developmental screening system comprised of age-specific questionnaires which measure 5 domains of infant development. 1. Unabbreviated scale title： Ages and Stages Questionnaires； 2. the minimum\~maximum value：0\~60 points； 3. Higher scores mean a better outcome.
Time frame: at 120, 180, and 275 days of age
MacArthur-Bates Communicative Development Inventory（CDI） tests
MacArthur-Bates Communicative Development Inventory (CDI) tests is administered at 365 days of age. It is a parent-report measure that has been validated against actual child language diaries. 1. Unabbreviated scale title：MacArthur-Bates Communicative Development Inventory evaluation form 2. the minimum\~maximum percentile：5%-99%； 3. The higher the percentile, the better；
Time frame: at 365 days of age
Carey Toddler Temperament Scale( TTS )tests
Carey Toddler Temperament Scale (TTS) tests is administered at 365 days of age. TTS is a 97-item questionnaire which measures the nine categories of temperament: activity level, regularity, adaptability, approach-withdrawal, intensity, mood, persistence, sensory threshold and distractibility. 1. Unabbreviated scale title：Carey Toddler Temperament Scale 2. Normal score range of TTS for 1 to 3 year old infants: Activity: 12.4 \~ 19.6 Fitness: 6.5 \~ 11.9 Emotional nature: 8.9 \~ 14.1 Regularity: 8 \~ 13 intensity: 11.5 \~ 18.1 Degree of distraction: 8 \~ 12.4 Below or above the normal range are temperament bias. 3. Temperament is innate and there is no difference between good and bad. infants with different temperament need different care.
Time frame: at 365 days of age
Infant attention
Single object attention and free play tasks is used to measure the infant's attention capabilities. The tasks assess overall fixation (attention) and looking away (inattention) in regards to novel and familiar objects.
Time frame: at 365 days of age
Achieve body weight
Achieve body weight (grams) of infants and toddlers at each study visit
Time frame: at 30, 90, 120, 180, 275, and 365 days of age
Achieve body length
Achieve body length (cm) of infants and toddlers at each study visit
Time frame: at 30, 90, 120, 180, 275, and 365 days of age
Achieve head circumference
Achieve head circumference (cm) of infants and toddlers at each study visit
Time frame: at 30, 90, 120, 180, 275, and 365 days of age
24-Hour dietary recall of Formula intake
The parent/caregiver need to record the amount of study formula consumed as well as any other infant formula or milk consumed since the last study visit
Time frame: at 30, 90, 120, 180, 275, and 365 days of age
24-Hour Recall of Stool Characteristics Questionnaire
The parent/caregiver will also be asked to recall the number of bowel movements and the stool consistency seen most often over the 24-hour period. Pictures will be provided to the participant's parent or caregiver for use as a guide in rating the stool consistency. Questionnaire: What stool consistency was seen most often in your baby's bowel movements over the past 24 hours?(Use pictures provided for reference) (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 For option 0\~5, 0 and 1 represent poor stool Characteristics , 2-5 represent fine stool Characteristics.
Time frame: at 30, 90, 120, 180, 275, and 365 days of age
24-Hour Recall of Tolerance Questionnaire
Tolerance information concerning how fussy and gassy the infant has been and if the infant has been more fussy and/or gassy than normal need to be recalled and recorded by parent/caregiver for the 24-hour period prior to the study visit. Questionnaire: 1. Over the past 24 hours, how fussy has your baby been? (0) Not at all fussy; (1)Slightly fussy; (2) Moderately fussy; (3) Very fussy; (4) Extremely fussy; 2. Over the past 24 hours, \_\_\_\_ was your baby? (0) Less fussy than normal ; (1) About the same level of fussiness as always; (2) More fussy than normal 3. Over the past 24 hours, how much gas has your baby had? (0) Not at all ; (1) Slightly amount of gas; (2) Moderate amount of gas; (3) Excessive amount of gas 4. Over the past 24 hours, did your baby have : (0) Less gas than normal; (1) About the same amount of gas as normal ; (2) More gas than normal For Question 1 \~ 4, the lower the score, the better.
Time frame: at 30, 90, 120, 180, 275, and 365 days of age
Percentages of adverse events
Number and percentages of infants in each group experiencing any medically-confirmed adverse events and any serious adverse events. 1. A medically-confirmed adverse event is defined as any unfavorable and unintended sign (including an abnormal laboratory finding that is considered clinically relevant by the Health Care Provider), including eyes, ear, nose and throat and the whole body manifestations, respiratory manifestations, dermatologic manifestations, Musculoskeletal manifestations, Metabolism and nutrition manifestations,etc. 2. An adverse event is considered serious if it meets one or more of the following criteria: * results in death * is life-threatening * requires inpatient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity, or * is a congenital anomaly/birth defect
Time frame: from 30 days of age to 365 days of age
Stool collection
Fecal microbiome analysis of samples collected at enrollment and at 120 days of age
Time frame: at enrollment and 120 days of age
Percentage of infants with oral antibiotic treatments
Percentage(%) of infants in each group using any oral antibiotic treatments.
Time frame: at 365 days of age
Percentage of infants with intramuscular antibiotic treatments
Percentage(%) of infants in each group using intramuscular antibiotic treatments.
Time frame: at 365 days of age
Percentage of infants with intravenous (IV) antibiotic treatments
Percentage(%) of infants in each group using intravenous (IV) antibiotic treatments.
Time frame: at 365 days of age
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