MedTrace Logo

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

NCT06372314 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

  • Neonates on TPN
  • Stable Neonates
  • Neonates Managed in the ICU

Interventions

DRUG

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.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06372314 on ClinicalTrials.gov