Skip to main content
OpenTrials
Completed

NCT Number: NCT06146387

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cognitive Change

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jinhua Nanyuan Community Health Center (site 1919), Jinhua, Zhejiang, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Newborn baby, study entry before weaning (within 28 days of birth)
  • Exclusively formula fed for at least 3 days prior to study entry and plan to be exclusively formula fed during the study (formula groups) OR plan to be exclusively fed with human milk during the study (breastfeeding group).
  • 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.) to 4200g (9 lbs. 4 oz.).
  • 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 the study.

Treatment and study plan

Investigational Formula

Dietary Supplement

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.

Control Formula

Dietary Supplement

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.

Breastfeeding

Dietary Supplement

Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.

Primary outcomes

  1. Bayley-III cognitive scale

    Time frame: At the age of 12 months

    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.

Secondary outcomes

  1. Weight in grams

    Time frame: At the age of 15-28 days and 3, 6, 9, 12 months

    The weight measurement (gram) of the participant for each site visit

  2. Height in cm

    Time frame: At the age of 15-28 days and 3, 6, 9, 12 months

    The height measurement (cm) of the participant for each site visit

  3. Head circumference in cm

    Time frame: At the age of 15-28 days and 3, 6, 9, 12 months

    The head circumference measurement (cm) of the participant for each site visit

  4. Amount of formula intake in ml

    Time frame: At the age of 15-28 days and 3, 6, 9, 12 months

    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

  5. Stool Characteristics Questionnaire

    Time frame: At the age of 15-28 days and 3, 6 months

    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.

  6. Medically-confirmed adverse events

    Time frame: baseline day to 12 months

    The frequency of medically-confirmed adverse events occurred during the study

Sponsors and collaborators

Lead sponsor

Heilongjiang Feihe Dairy Co. Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2023
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.