Studying Isoleucine, Leucine, Valine, and Tryptophan Needs in Stable Preterm Neonates Receiving Total Parenteral Nutrition TPN

What this Trial Is About

Researchers are evaluating the requirements for four essential amino acids isoleucine, leucine, valine, and tryptophan in neonates who receive total parenteral nutrition TPN. This study will take place at two hospitals in Brazil and aims to better understand how much of each amino acid these stable, TPN-fed preterm babies need. The research uses the Carbon Oxidation method to measure amino acid oxidation and determine the babies nutritional requirements. Each baby will receive one or two levels of either isoleucine, leucine, valine, or tryptophan over a two-day period. On the first day, the baby will receive a standard pediatric amino acid solution along with a labeled bicarbonate to measure carbon dioxide production. On the second day, the baby will receive a test TPN solution with varying amounts of the specific amino acid being studied, including a small amount of labeled phenylalanine to track amino acid oxidation. Breath, urine, and blood samples will be collected to analyze amino acid use and plasma concentrations. During the study, breath and urine samples will be collected to measure amino acid oxidation, and blood samples will be taken alongside routine clinical blood work to assess plasma amino acid levels. The main outcome measured is amino acid oxidation over 48 hours. The study will include stable preterm neonates born at or after 28 weeks gestation, up to 28 days old, who are fully TPN fed. Participation involves close monitoring in the NICU with sample collections coordinated to minimize discomfort.

Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates