Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06372314 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Isoleucine, Leucine, Valine and Tryptophan Requirements in TPN Fed Neonates

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2025 to Jan 1, 2026
    • Site details revised
    v3
  3. Start date: Aug 2024 to Aug 1, 2025v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06372314
Lead Sponsor The Hospital for Sick Children
Conditions
(from sponsor)		 Neonates on TPN, Stable Neonates, Neonates Managed in the ICU
Related terms Hyperphagia
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov