Condition: Neonates on TPN · Stable Neonates · Neonates Managed in the ICU · Sponsor: The Hospital for Sick Children
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.
This description comes directly from the study's public registry record.
Glenda Courtney-Martin, PhD · 416 813 5744 · glenda.courtney-martin@sickkids.ca
Mahroukh Rafii, BSc · 4168137454 · mahroukh.rafii@sickkids.ca
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| Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil | Santa Maria, Brazil | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06372314