RecruitingNot ApplicableNCT05562310

Phenylalanine, Methionine and Histidine Requirements in TPN Fed Neonates

Phenylalanine, Methionine and Histidine Requirements in Total Parenteral Nutrition (TPN) Fed Neonates


Sponsor

The Hospital for Sick Children

Enrollment

60 participants

Start Date

Apr 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 1 DayMax Age: 28 Days

Plain Language Summary

Simplified for easier understanding

This study measures the nutritional needs of premature newborns receiving all their nutrition through an IV (called total parenteral nutrition, or TPN). Specifically, it looks at how much of three amino acids — phenylalanine, methionine, and histidine — preterm babies need to grow and develop properly. Knowing this helps doctors provide better nutrition for premature infants. You may be eligible if... - Your baby is premature, born at 28 weeks gestation or later - Your baby is stable, growing, and receiving at least 90% of nutrition through TPN - Your baby is 28 days old or younger - Your baby has a birth weight and length appropriate for gestational age - Your baby has been medically stable (normal blood results, no fever or infection) - If your baby had surgery, it has been at least 3 days since the operation You may NOT be eligible if... - Your baby is on mechanical ventilation, low-flow oxygen, or CPAP - Your baby is small for gestational age - Your baby is on medications that affect protein metabolism - Your baby has a documented infection or fever - Your baby is receiving more than 10% of protein intake through feeds Talk to your baby's doctor to see if this trial is right for your family.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTotal parenteral nutrition (TPN). This is total nutrition provided by central vein.

phenylalanine, methionine and histidine 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)

Glenda Courtney-Martin

Toronto, Ontario, Canada

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NCT05562310


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