Recruiting

TPN with Amino Acids

Sponsor:

The Hospital for Sick Children

Code:

NCT05562310

Conditions

Stable Neonates

Receiving Total Parenteral Nutrition (TPN)

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief summary:

This is a single center project assessing the requirements for three 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 3 amino acids. The investigators will first determine the requirement for Phenylalanine, then Methionine and finally Histidine. 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 (phenylalanine, methionine, and histidine) 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 phenylalanine, methionine and histidine will be at least 50% lower than what is currently available in commercial amino acids solutions used for TPN feeding of neonates.

Conditions

Stable Neonates

Receiving Total Parenteral Nutrition (TPN)

Study ID

NCT05562310

Start date

Apr 2, 2023

Status verified date

May, 2025

Completion date

Sep 2, 2027

Anticipated

Primary completion date

Sep 2, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Phenylalanine, methionine, histidine requirement

Interventions

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

phenylalanine, methionine and histidine 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 outcome measure

  • Amino acid oxidation using a labelled amino acid. [ Time Frame: 48 hrs ]

Central Contacts and Locations

Central contacts

Glenda Courtney-Martin

4168135744glenda.courtney-martin@sickkids.ca

Mahroukh Rafii

6472151201mahroukh.rafii@sickkids.ca

Locations

Glenda Courtney-Martin

Recruiting

Toronto, Ontario, Canada, M5G 1X8

Contacts

Glenda Courtney-Martin

4168135744glenda.courtney-martin@sickkids.ca

More Information

Sponsor

The Hospital for Sick Children

Last update posted

May 30, 2025

Last verified

May, 2025

Keywords

  • Neonates
  • Total parenteral nutrition (TPN)
  • Phenylalanine
  • Methionine
  • Histidine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2025-05-30.