NCT04013087

Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants

Randomized, Double-blind, Parallel, Controlled Study to Evaluate the Safety and Nutritional Adequacy of a New Infant Formula in Healthy Term Infants

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Heilongjiang Feihe Dairy Co. Ltd. · Industry
• Sex: All
• Age: 10 Days – 14 Days
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Child Development

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Oral feeding of Feihe Stage 1 infant formula	Oral feeding of Feihe Stage 1 infant formula for 16 weeks
DIETARY_SUPPLEMENT	Oral feeding of control Stage 1 formula	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))
DIETARY_SUPPLEMENT	Breast feeding	Breast feeding of human milk for 16 weeks

Timeline

• Start date: 2019-07-08
• Primary completion: 2020-04-19
• Completion: 2020-12-30
• First posted: 2019-07-09
• Last updated: 2020-04-24

Locations

3 sites across 1 country: China