Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates
Recruiting now · Not applicable
Conditions studied: Neonates on TPN, Stable Neonates, Neonates Managed in the ICU
In brief
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.
Key facts
- Study ID
- NCT06372314
- Run by
- The Hospital for Sick Children
- People needed
- 80
- Starts
- 2026-01-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-04-02
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 may not qualify if…
- 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
Where it is running
- Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil — Santa Maria, Brazil (enrolling)
Full record on ClinicalTrials.gov
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