Individualized Nutrition to Optimize Preterm Infant Growth and Neurodevelopment

Launched by CHILDREN'S NATIONAL RESEARCH INSTITUTE · Feb 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how different methods of adding nutrients to human milk can help very premature infants grow better and develop their brains. Because human milk alone may not provide enough nutrition for these infants, doctors typically add a standard mix of nutrients, but this approach doesn’t always meet each baby’s unique needs. Researchers want to compare three different ways of fortifying human milk: the usual standard method, a method that adjusts based on the baby's protein needs, and a targeted method that analyzes the milk to figure out its specific nutrient content. The goal is to see which method helps babies grow and develop better.

To participate in this trial, infants must be born at 32 weeks or earlier and be less than 4 weeks old when they join. Their mothers should plan to provide human milk, and the baby should not have any serious health issues that might interfere with the study. Participants will receive one of the three types of fortified milk until they reach a certain age or are ready to go home. Throughout the study, the babies will have regular check-ups, including brain scans, to monitor their growth and development up to the age of five. This study is important because it aims to find better ways to support the health and development of very premature infants.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Birth gestational age (GA) of ≤32 weeks
• • Postnatal age ≤4 weeks at time of enrollment
• • Maternal plan to provide human milk to infant, and consent to providing donor human milk if insufficient maternal milk supply
• • Maternal age \> 18 years old
• Exclusion Criteria:
• • Formula feeding prior to 36 weeks PMA or discharge home (whichever achieved first), either secondary to parental preference or medical necessity
• • Dysmorphic features or congenital anomalies suggestive of a genetic syndrome, metabolic disorder, chromosomal abnormality, or congenital infection
• • Dysgenetic or major destructive brain lesions detected by head ultrasound before enrollment