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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
Secondary Objectives
To compare between the two study groups:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Formula (Stage 1&2) | Experimental | Investigational formula contains DHA,ARA and enriched whey protein (source of milk fat globule membrane) to support the healthy growth and Cognitive development of infants. |
|
| Control formula (Stage 1&2) | Active Comparator | Control formula have comparable macronutrients and micronutrients, but does not contain DHA,ARA and MFGM. |
|
| Breast feeding | Other | Breast fed of human milk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral feeding of Investigational Formula (Stage 1&2) | Dietary Supplement | Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age. |
| Measure | Description | Time Frame |
|---|---|---|
| Infant 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.
| at 365 days of age |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
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Inclusion Criteria:
Exclusion Criteria:
Additional Criteria for Inclusion in the Stool Collection Subset
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang, MD | Contact | +86 21 51097272 | charlie.zhang@sprim.cn | |
| Wei Zhang, PhD | Contact | +86 10 8457 4688 | zhangwei1@feihe.com |
| Name | Affiliation | Role |
|---|---|---|
| Gong Zhang, M.D., Ph.D. | Anhui Medical University Affiliated Children's Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinhua Nanyuan Community Health Center (site 1919) | Recruiting | Jinhua | Zhejiang | China |
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| ID | Term |
|---|---|
| D007774 | Lactation |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D049590 | Postpartum Period |
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| Oral feeding of Control formula (Stage 1&2) | Dietary Supplement | Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age. |
|
| Breast feeding | Dietary Supplement | Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula. |
|
| 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.
| 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.
| 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.
| 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.
| 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.
| 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.
| 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. | at 365 days of age |
| Achieve body weight | Achieve body weight (grams) of infants and toddlers at each study visit | 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 | 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 | 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 | 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;
For option 0~5, 0 and 1 represent poor stool Characteristics , 2-5 represent fine stool Characteristics. | 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:
For Question 1 ~ 4, the lower the score, the better. | 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.
| 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 | 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. | at 365 days of age |
| Percentage of infants with intramuscular antibiotic treatments | Percentage(%) of infants in each group using intramuscular antibiotic treatments. | at 365 days of age |
| Percentage of infants with intravenous (IV) antibiotic treatments | Percentage(%) of infants in each group using intravenous (IV) antibiotic treatments. | at 365 days of age |
| Jinhua Qiubin Community Health Center (site 1969) | Recruiting | Jinhua | Zhejiang | China |
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| Jinhua Xiguan Community Health Center (site 1966) | Recruiting | Jinhua | Zhejiang | China |
|