This study is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective study and is intended to evaluate the nutritional adequacy and tolerance of a new study formula compared with a concurrent control formula. Approximately 450 infants will be enrolled from approximately 3 China sites. Of these infants, approximately 300 will be randomized 1:1 to receive an investigational formula or a control formula for 16weeks of feeding. The remaining approximately 150 infants will be enrolled as a breastfeeding reference group. The primary outcome measure is the rate of weight gain in g/day between baseline and 16 weeks in the test group compared to control formula group. Participants will have the option of providing stool samples at 8 weeks and 16 weeks for analysis of microbiota and metabolomics. The study period will be 16 weeks, and all infants in the 2 formula groups will receive formula free of charge for 6 months.
Primary Objective 1\) Compare the rate of weight gain (in g/day) between infants receiving an investigational formula and infants receiving a control formula between at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks. Secondary Objectives 1. Compare rate of change in length (mm/day) among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks. 2. Compare rate of change in head circumference (mm/day) among infants receiving an investigational formula, infants receiving a control formula and breastfeeding infants at baseline (B), B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks. 3. Evaluate and compare achieved body weight, length, and head circumference at each visit and after 16 weeks. 4. Evaluate plotted raw growth data on World Health Organization standard growth charts.1 5. Compare the types and incidence of adverse events among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants. 6. Compare average daily intake of formula between infants receiving an investigational formula and infants receiving a control formula. 7. Compare parents' and physician's assessment of formula tolerance among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants. 8. Compare counts of Bifidobacteria and Lactobacillus species in stools of infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants. 9. Compare stool short-chain fatty acid metabolites (including total SCFAs, acetic, propionic, n-butyric, iso-butyric and n-valeric acids, L-lactic acid and D-lactic acid, etc) among infants receiving an investigational formula, infants receiving a control formula, and breastfeeding infants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
450
Oral feeding of Feihe Stage 1 infant formula for 16 weeks
Oral feeding of control Stage 1 formula for 16 weeks (A commercially available product with comparable composition but does not contain sn-2 palmitate enriched vegetable oil as an ingredient (regular vegetable oil is used))
Breast feeding of human milk for 16 weeks
Jinhua Nanyuan Community Health Center (site 1919)
Jinhua, Zhejiang, China
Jinhua Qiubin Community Health Center (site 1969)
Jinhua, Zhejiang, China
Jinhua Xiguan Community Health Center (site 1966)
Jinhua, Zhejiang, China
Rate of change in body weight (grams/day) from baseline
Rate of change in body weight (grams/day) between baseline and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Rate of change in body length (mm/day) from baseline
Rate of change in length (mm/day) measured between baseline (B) and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Rate of change in head circumference (mm/day) from baseline
Rate of change in head circumference (mm/day) measured between baseline (B) and B+2 weeks, B+4 weeks, B+8 weeks, B+12 weeks, and B+16 weeks.
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved body weight
Achieved body weight (grams) at each study visit
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved body length
Achieved body length (cm) at each study visit
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Achieved head circumference
Achieved head circumference (cm) at each study visit
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Percentages of infants in each group who are <10th percentile in weight for age.
Percentages of infants in each group who are \<10th percentile in weight for age.
Time frame: 16 weeks
Percentages of infants in each group who are <10th percentile in length for age.
Percentages of infants in each group who are \<10th percentile in length for age.
Time frame: 16 weeks
Percentages of infants in each group who are <10th percentile in head circumference for age.
Percentages of infants in each group who are \<10th percentile in head circumference for age.
Time frame: 16 weeks
Adverse events rate
Number and percentages of infants in each group experiencing any adverse events and any serious adverse events
Time frame: 16 weeks
Average daily formula intake
Average daily formula intake volume based on 3-day records kept by parents or care-givers prior to each study visit.
Time frame: 2 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks
Percentage of fussiness
Percentages of parents in each group reporting fussiness
Time frame: 16 weeks
Percentage of colic
Percentages of parents in each group reporting colic
Time frame: 16 weeks
Percentage of patterns
Percentages of parents in each group reporting sleeping patterns
Time frame: 16 weeks
Percentage of cramps
Percentages of parents in each group reporting cramps
Time frame: 16 weeks
Percentage of regurgitation
Percentages of parents in each group reporting regurgitation
Time frame: 16 weeks
Stool characteristics
Score of stool characteristics
Time frame: 16 weeks
Percentage of respiratory manifestations
Percentages of parents in each group reporting respiratory manifestations
Time frame: 16 weeks
Percentage of dermatologic manifestations
Percentages of parents in each group reporting dermatologic manifestations
Time frame: 16 weeks
Fecal Bifidobacteria counts
Total fecal Bifidobacteria counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.
Time frame: 8 weeks,16 weeks
Fecal Lactobacillus counts
Total fecal Lactobacillus counts (mean log10 counts / g wet-weight stool) at 8 weeks and 16 weeks.
Time frame: 8 weeks,16 weeks
Stool short-chain fatty acid
Total stool short-chain fatty acid metabolites in mg/g dry stool at 8 weeks and 16 weeks.
Time frame: 8 weeks,16 weeks
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