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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Formula | Experimental | Feihe Investigational Formula
|
|
| Control Formula | Active Comparator | Control formula contains comparable macronutrients and micronutrients, but does not contain HMO, DHA and ARA. |
|
| Breastfeeding | Other | breastmilk-feeding |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Formula | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yajun Xu, MD | Peking University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinhua Nanyuan Community Health Center (site 1919) | Jinhua | Zhejiang | China | |||
| Li Pu Community Hospital |
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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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Two arms of participants will be assigned masked products (investigational formula and control formula) after randomization, while the participants of breastfeeding arm will not be assigned study products.
| Control Formula | Dietary Supplement | 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. |
|
| Breastfeeding | Dietary Supplement | Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula. |
|
| 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;
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 |
| Jinhua |
| Zhejiang |
| China |
| Qiu Bin Community Hospital | Jinhua | Zhejiang | China |