Effects of enhanced infant formula on growth and development
The Effect of Adding Milk Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on the Growth and Development of Infants Aged 0-1 Years: a Multicenter, Double-blind, Randomized, Controlled Trial
This study tests if a special infant formula with added nutrients can help babies under one year old grow and develop better compared to regular formula and breastfeeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 0 Days to 28 Days |
| Sex | All |
| Sponsor | Heilongjiang Feihe Dairy Co. Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06569797 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the impact of infant formula supplemented with milk oligosaccharides and optimized with multiple nutrients on the growth and development of infants under one year old. It compares the effects of this enhanced formula against conventional infant formula and breastfeeding, focusing on various health indicators such as immune function, intestinal health, and cognitive development. The study involves 240 infants divided into experimental, control, and breastfeeding groups to assess differences in health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy infants aged 0-28 days who are single births and meet specific birth weight and gestational age criteria.
Not a fit: Patients who may not benefit include those with congenital malformations, genetic diseases, or any acute infections that could interfere with the study.
Why it matters
Potential benefit: If successful, this study could lead to improved infant nutrition and health outcomes through optimized formula feeding.
How similar studies have performed: Other studies have shown promising results with similar approaches to enhancing infant formula, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 0-28 days after birth; * Single birth; * The gestational age is between 37 and 42 weeks; * Birth weight ranges from 2500 to 4000 grams; * Parents or guardians agree not to allow infants to participate in other interventional clinical studies during the study period Exclusion Criteria: * Artificial assisted reproduction; * The mother suffers from a disease that may endanger intrauterine growth; * The mother suffers from pregnancy diabetes or serious metabolic disease or chronic disease during pregnancy * Suffering from congenital malformations and genetic diseases, chronic diseases, and congenital diseases that may interfere with the investigation; * Suffering from IgE mediated milk protein allergy, or having factors that increase the risk of milk protein allergy; * Suffering from acute infection or gastroenteritis; * Suffering from functional gastrointestinal diseases, such as gastroparesis; * Currently participating in other clinical trials; * Researchers cannot determine whether parents have the willingness or ability to comply with the requirements of the protocol.
Where this trial is running
Beijing, Beijing Municipality
- The Seventh Medical Center of the General Hospital of the Chinese People's Liberation Army — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Hao W Su, Master
- Email: suwuhao@esmile.com.cn
- Phone: +8613413399214
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.