Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai Children's Medical Center | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enriched Protein Fractions | Experimental | This group is given Infant formula with enriched protein fractions. |
|
| Protein Fractions | Active Comparator | This group is given Infant formula with protein fractions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enriched Protein Fractions | Dietary Supplement | Enriched protein fractions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Infant cognitive development | Cognitive Scale of Bayley-III is used as the assessment tool. | At 12 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Infant cognitive development | Cognitive Scale of Bayley-III is used as the assessment tool. | At 18 months of age |
| Infant language and motor skills | Ages and Stages Questionnaire, MacArthur-Bates Communicative Development Index, Language Scale and Motor Scale of Bayley-III are used as the assessment tool. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| John Colombo, Doctor | University of Kansas | Study Chair |
| Fei Li, Doctor | Shanghai Children's Medical Center | Study Chair |
| Bryan Liu, Doctor | Mead Johnson Nutrition | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuyang Fifth People's Hospital | Fuyang | Anhui | China | |||
| Fuyang Maternal and Child Health Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33981943 | Derived | Chichlowski M, Bokulich N, Harris CL, Wampler JL, Li F, Berseth CL, Rudolph C, Wu SS. Effect of Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula on Gut Microbiome and Metabolome at 4 Months of Age. Curr Dev Nutr. 2021 Apr 2;5(5):nzab027. doi: 10.1093/cdn/nzab027. eCollection 2021 May. | |
| 31668885 | Derived |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Protein Fractions |
| Dietary Supplement |
Protein fractions |
|
| At 4, 6, 9, 12 and 18 months of age |
| Infant acquisition of social and emotional milestones and adaptive development | Ages and Stages Questionnaire, social-emotional scale and adaptive behavior scale of Bayley-III are used as assessment tool. | At 4, 6, 9, 12 and 18 months of age |
| Infant temperament | Carey Scale is used as assessment tool. | At 12 and 18 months of age |
| Infant attention capabilities | Single Object Attention and Free Play Tasks is used as assessment tool. | At 12 and 18 months of age |
| Physical development | Body weight, length and head circumference are measured. | At 14, 30, 42, 60, 90, 120, 180, 275, 365, and 545 days of age |
| Stool characteristics | According to the recall of parents during the last 24 hours. | At 14, 30, 42, 60, 90, 120, 180, 275 and 365 days of age |
| Formula intake | According to the recall of parents during the last 24 hours. | At 30, 42, 60, 90, 120, 180, 275 and 365 days of age |
| Fecal microbiome and metabolome profile | Fecal microbiome analysis is done at average of 14 days and 120 days of age. While metabolome profile analysis is done at only average of 120 days of age. | Average of 14 days of age and 120 days of age |
| Medically-confirmed Adverse Events | Up to 19 months of age |
| Fuyang |
| Anhui |
| China |
| Yinquan Maternal and Child Health Institute | Fuyang | Anhui | China |
| Li F, Wu SS, Berseth CL, Harris CL, Richards JD, Wampler JL, Zhuang W, Cleghorn G, Rudolph CD, Liu B, Shaddy DJ, Colombo J. Improved Neurodevelopmental Outcomes Associated with Bovine Milk Fat Globule Membrane and Lactoferrin in Infant Formula: A Randomized, Controlled Trial. J Pediatr. 2019 Dec;215:24-31.e8. doi: 10.1016/j.jpeds.2019.08.030. Epub 2019 Oct 24. |