Effect of Oligosaccharides and Optimizing Multiple Nutrients to Infant Formula on Growth and Development of Infants

Launched by HEILONGJIANG FEIHE DAIRY CO. LTD. · Aug 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different types of infant formula can affect the growth and development of healthy infants under 1 year old. Specifically, researchers want to see how infant formula that includes special sugars called oligosaccharides and is enriched with various nutrients compares to regular infant formula. They are looking at how these formulas influence things like immune function, intestinal health, and cognitive development, and they will also compare the effects to those of breastfed infants.

To participate in the study, infants need to be between 0 and 28 days old, born full-term (between 37 and 42 weeks gestational age), and have a birth weight between 2500 and 4000 grams. Parents or guardians must agree not to enroll their infants in any other clinical studies during the trial. If eligible, participants can expect to receive the assigned formula and will be monitored for their growth and health throughout the study. This research aims to help improve infant nutrition and development based on the findings.

Gender

ALL

Eligibility 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.