Phenylalanine, Methionine and Histidine Requirements in TPN Fed Neonates

Recruiting now · Not applicable

Conditions studied: Stable Neonates, Receiving Total Parenteral Nutrition (TPN)

In brief

This is a single center project assessing the requirements for three 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 3 amino acids. The investigators will first determine the requirement for Phenylalanine, then Methionine and finally Histidine. 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 (phenylalanine, methionine, and histidine) 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 phenylalanine, methionine and histidine will be at least 50% lower than what is currently available in commercial amino acids solutions used for TPN feeding of neonates.

Key facts

Study ID

NCT05562310

Run by

The Hospital for Sick Children

People needed

60

Starts

2023-04-02

Expected to finish

2027-09-02

Last updated by the study team

2025-05-30

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

• Glenda Courtney-Martin — Toronto, Ontario, Canada (enrolling)

Full record on ClinicalTrials.gov

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