Actively Recruiting
Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates
Led by The Hospital for Sick Children · Updated on 2026-04-02
80
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stable preterm babies that are growing and fully TPN fed (at least 90% of calories and protein)
- TPN providing adequate calories and protein as determined by attending physician and dietitian
- Babies born 28 weeks gestation
- 28 days chronological age at the time of the study
- Birth weight and length appropriate for gestational age
- Medically stable as determined by normal blood results and lack of a fever or infection
- At least 3 days after surgery, if the baby had a surgery
You will not qualify if you...
- Babies on mechanical ventilation, on low flow oxygen and CPAP
- Small for gestational age
- On medications known to affect protein and amino acid metabolism
- Documented infection, fever
- Unstable medical condition
- Receiving enteral feeding providing > 10% of protein intake
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil
Santa Maria, Brazil
Actively Recruiting
Research Team
G
Glenda Courtney-Martin, PhD
CONTACT
M
Mahroukh Rafii, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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