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NCT Number: NCT06372314

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

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.

Recruiting

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Key information

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil

Santa Maria, Brazil

Location status: Recruiting

Location contact

Beatriz Dr Porto, MD

CONTACT

[email protected]

6475002171

Ivo Dr Prola, MD, PhD

CONTACT

[email protected]

6477815786

About this study

The study is based on the carbon oxidation protocol. Each baby will receive one or two levels of either isoleucine or leucine or valine or tryptophan. Each level will be assessed over a two- day period.

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 Isoleucine/ Leucine/ Valine/ Tryptophan 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 routine blood work done for clinical monitoring.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable preterm babies that are growing and fully TPN fed (at least 90% of calories and protein).
  • TPN providing adequate calories and protein as determined by attending physician and dietitian.
  • Babies born ≥ 28 weeks gestation,
  • ≤ 28 days chronological age at the time of the study,
  • Birth weight and length appropriate for gestational age,
  • Medically stable as determined by normal blood results and lack of a fever or infection,
  • At least 3 days after surgery, if the baby had a surgery

Exclusion criteria

  • Babies on mechanical ventilation, on low flow oxygen and CPAP.
  • Small for gestational age,
  • On medications known to affect protein and amino acid metabolism,
  • Documented infection, fever
  • Unstable medical condition
  • Receiving enteral feeding providing > 10% of protein intake

Treatment and study plan

Total parenteral nutrition (TPN): this is total nutrition provided by central vein.

Drug

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.

Primary outcomes

  1. Amino acid oxidation using a labelled amino acid.

    Time frame: 48 hrs

    Breath samples will be collected and analyzed to determine the amount ofamino acid oxidized. This will be used to determine the amount retained inthe body and therefore the amount that is required for protein synthesis.

Study contacts

Contact information is provided by the study sponsor or research team.

Glenda Courtney-Martin, PhD

CONTACT

[email protected]

416 813 5744

Mahroukh Rafii, BSc

CONTACT

[email protected]

4168137454

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Isoleucine, Leucine, Valine and Tryptophan Requirements in Total Parenteral Nutrition (TPN) Fed Neonates

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 18, 2024
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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