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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Change
• Intervention / Treatment: Dietary supplement: Control Formula; Dietary supplement: Investigational Formula; Dietary supplement: Breastfeeding

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grace Zhang, MA; Phone Number: +8615801911679; Email: grace.zhang@sprimmedical.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Kaitai Scientific Lab
      • Contact: Charlie Zhang, MD; Phone Number: +8613901981272; Email: charlie.zhang@sprimmedical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Newborn baby, study entry before weaning (within 28 days of birth)
• Exclusively formula for at least 3 days fed prior to onset of study period.
• Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age).
• Birth weight of 2500g (5 lbs. 8 oz.) or more.
• Signed informed consent obtained for infant's participation in the study.
• Parent or guardian of the infant agrees to not enroll the infant in another interventional clinical research study while participating in this study.

Exclusion Criteria:

• History of underlying metabolic or chronic disease; congenital malformation; or any other condition which, in the opinion of the Investigator, is likely to interfere with: the ability of the infant to ingest food, the normal growth and development of the infant, or the evaluation of the infant.
• Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake, at time of randomization (at investigator discretion).
• Evidence of growth problems or concern for growth.
• Infant was born large for gestational age (LGA) (defined as birth weight-for-age exceeding 90th percentile as plotted on the growth chart provided by Feihe) from mother who was diabetic at childbirth.
• Participant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury.
• Use of probiotics/prebiotics before and during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Breastfeeding; breastmilk-feeding	Dietary supplement: Breastfeeding; Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.
Experimental: Investigational Formula; Feihe Investigational Formula; Contains 2 kinds of HMOs; 5 kinds of phospholipid content reached the level of breast milk; DHA&ARA reaches the content and proportion of breast milk in China; Comprehensive nutrition: OPO, probiotics, lactoferrin, CPP, nucleotide, choline, inositol, taurine, L-carnitine, GOS, lutein	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.
Active Comparator: Control Formula; Control formula contains comparable macronutrients and micronutrients, but does not contain HMO, DHA and ARA.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height in cm	The height measurement (cm) of the participant for each site visit	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
Medically-confirmed adverse events	The frequency of medically-confirmed adverse events occurred during the study	baseline day to 12 months
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
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; Hard- dry, hard pellets;; Formed- definite shape, not dry;; Soft-no definite shape, pasty;; Unformed or seedy- no shape, some water or small lumps ;; Waterly- no shape, mainly water 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

Collaborators and Investigators

• Sponsor: Heilongjiang Feihe Dairy Co. Ltd.
• Investigators: Principal Investigator: Charlie Zhang, MD, SPRIM Medical

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2023
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): April 30, 2025

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: November 19, 2023
• First Posted (Actual): November 24, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: HMO (Human Milk Oligosaccharides); Bayley-III Cognitive Scale; Feihe Infant Formula; DHA (Dehydroascorbic Acid); ARA (Arachidonic Acid)
• Other Study ID Numbers: 22-SM-11-FEIHE-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No