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Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates
Sponsor: The Hospital for Sick Children
Summary
This project will be conducted in 2 hospitals in Brazil to assess the requirements for four essential amino acids in TPN fed neonates. Using the Carbon Oxidation method (indicator amino oxidation and direct amino acid oxidation method), the investigators will determine the requirement of each of the 4 amino acids. The investigators will determine the requirement for Isoleucine, Leucine, Valine and Tryptophan. The investigators will recruit 18- 20 babies per amino acid study. Breath and urine samples will be collected to determine the oxidation of the indicator amino acid. The response of the indicator amino acid to changes in intake of the test amino acid (isoleucine, leucine, valine and tryptophan) will be analyzed by bi-phase linear mixed effect model to determine the breakpoint or mean requirement for each amino acid. It is hypothesized that the requirement for isoleucine, leucine, valine and tryptophan will be at least 50% lower than what is currently available in commercial solutions used for TPN feeding of neonates.
Official title: Isoleucine, Leucine, Valine and Tryptophan Requirements in Total Parenteral Nutrition (TPN) Fed Neonates
Key Details
Gender
All
Age Range
1 Day - 28 Days
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-01-01
Completion Date
2027-12
Last Updated
2026-04-02
Healthy Volunteers
No
Interventions
Total parenteral nutrition (TPN): this is total nutrition provided by central vein.
isoleucine, leucine, valine and tryptophan intakes will be varied in the TPN solutions to study the requirements for each of these amino acids in neonates that are TPN fed.
Locations (1)
Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil
Santa Maria, Brazil