NCT06372314 Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates
| NCT ID | NCT06372314 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Hospital for Sick Children |
| Condition | Neonates on TPN |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2026-01-01 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Stable preterm babies that are growing and fully TPN fed (at least 90% of calories and protein). 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: 1. Babies on mechanical ventilation, on low flow oxygen and CPAP. 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06372314 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 28 Days, studying Neonates on TPN. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06372314 currently recruiting?
Yes, NCT06372314 is actively recruiting participants. Contact the research team at glenda.courtney-martin@sickkids.ca for enrollment information.
Where is the NCT06372314 trial being conducted?
This trial is being conducted at Santa Maria, Brazil.
Who is sponsoring the NCT06372314 clinical trial?
NCT06372314 is sponsored by The Hospital for Sick Children. The trial plans to enroll 80 participants.