Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates
NCT ID: NCT06372314
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
80 participants
INTERVENTIONAL
2025-08-01
2027-12-31
Brief Summary
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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.
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Detailed Description
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On day 1: each baby will receive a standard pediatric amino acid solution, Primene used in the NICU and L-\[1-13C\]Na Bicarbonate will be given to measure carbon dioxide production.
On day 2: he/she will receive the appropriate TPN Test Solution made up of the appropriate Bulk Amino Acid solution (for Isoleucine/ Leucine/ Valine/ Tryptophan Studies) with a different amount of the amino acid being investigated. To see how these amino acids are used in the body the investigators will add a small amount (calculated based on the body weight of the baby) of the amino acid L-\[1-13C\]phenylalanine to the amino acid solution. Breath and urine will be collected from the baby to study the oxidation of the L -\[1-13C\]phenylalanine. The investigators will take 2 x 0.75 ml blood to measure plasma amino acid concentration. The investigators will aim to coordinate blood taking with routine blood work done for clinical monitoring.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Isoleucine, leucine, valine, tryptophan requirement
isoleucine, 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.
Total parenteral nutrition (TPN): this is total nutrition provided by central vein.
isoleucine, 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.
Interventions
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Total parenteral nutrition (TPN): this is total nutrition provided by central vein.
isoleucine, 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.
Eligibility Criteria
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Inclusion Criteria
2. TPN providing adequate calories and protein as determined by attending physician and dietitian.
3. Babies born ≥ 28 weeks gestation,
4. ≤ 28 days chronological age at the time of the study,
5. Birth weight and length appropriate for gestational age,
6. Medically stable as determined by normal blood results and lack of a fever or infection,
7. At least 3 days after surgery, if the baby had a surgery
Exclusion Criteria
2. Small for gestational age,
3. On medications known to affect protein and amino acid metabolism,
4. Documented infection, fever
5. Unstable medical condition
6. Receiving enteral feeding providing \> 10% of protein intake
1 Day
28 Days
ALL
No
Sponsors
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The Hospital for Sick Children
OTHER
Responsible Party
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Glenda Courtney-Martin
Principal Investigator
Locations
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Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil
Santa Maria, , Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1000081221
Identifier Type: -
Identifier Source: org_study_id
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