Improving cognitive development in infants with a special formula
A Randomized, Controlled Trial of Improved Cognitive Outcomes Associated With Feihe HMO With DHA/ARA in Infant Formula
This study is testing a special infant formula to see if it can help improve thinking skills in babies compared to a regular formula and breastfeeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 1 Day to 28 Days |
| Sex | All |
| Sponsor | Heilongjiang Feihe Dairy Co. Ltd. Industry-sponsored |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06146387 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a Feihe investigational infant formula containing Human Milk Oligosaccharides (HMO), DHA, and ARA in enhancing cognitive development in newborns. A total of 240 participants will be randomly assigned to one of three groups: the investigational formula, a control formula, or breastfeeding, with assessments conducted at 12 months using the Bayley-III cognitive scale. Participants will have up to six site visits during the study to collect clinical data and monitor progress.
Who should consider this trial
Good fit: Ideal candidates for this study are newborns aged 28 days or younger who are exclusively formula-fed and meet specific health criteria.
Not a fit: Patients with underlying metabolic or chronic diseases, congenital malformations, or feeding difficulties may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive outcomes in infants fed with the investigational formula.
How similar studies have performed: While similar studies have explored cognitive development in infants, this specific combination of HMO, DHA, and ARA in formula is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hangzhou, Zhejiang
- Kaitai Scientific Lab — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Charlie Zhang, MD — SPRIM Medical
- Study coordinator: Grace Zhang, MA
- Email: grace.zhang@sprimmedical.com
- Phone: +8615801911679
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.