NCT06146387

Improved Cognitive Outcomes Associated With Feihe HMO With DHA/ARA in Infant Formula

Improved Cognitive Outcomes Associated With Feihe HMO With DHA/ARA in Infant Formula: A Randomized, Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Heilongjiang Feihe Dairy Co. Ltd. · Industry
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Cognitive Change

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Investigational Formula	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.
DIETARY_SUPPLEMENT	Control Formula	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.
DIETARY_SUPPLEMENT	Breastfeeding	Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.

Timeline

• Start date: 2023-11-14
• Primary completion: 2025-04-03
• Completion: 2025-04-03
• First posted: 2023-11-24
• Last updated: 2025-12-08

Locations

3 sites across 1 country: China