Phenylalanine, Methionine and Histidine Requirements in TPN Fed Neonates
NCT ID: NCT05562310
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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RECRUITING
NA
60 participants
INTERVENTIONAL
2023-04-02
2027-09-02
Brief Summary
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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.
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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 Phenylalanine/ Methionine/ Histidine 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 regular 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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Phenylalanine, methionine, histidine requirement
Total 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.
Interventions
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Total 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.
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
Principle Investigator
Locations
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Glenda Courtney-Martin
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1000076474
Identifier Type: -
Identifier Source: org_study_id
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