Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-28
SponsorThe Hospital for Sick Children
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Total parenteral nutrition (TPN): this is total nutrition provided by central vein.
Drugisoleucine, 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.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Isoleucine, leucine, valine, tryptophan requirementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Amino acid oxidation using a labelled amino acid.
Breath samples will be collected and analyzed to determine the amount ofamino acid oxidized. This will be used to determine the amount retained inthe body and therefore the amount that is required for protein synthesis.
Time frame
48 hrsSponsors and contacts
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Source ClinicalTrials.gov