Stable NeonatesNCT05562310
Phenylalanine, Methionine and Histidine Requirements in TPN Fed Neonates
A study testing Total parenteral nutrition (TPN). This is total nutrition provided by central vein. in people with Stable Neonates and Receiving Total Parenteral Nutrition (TPN), run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Stable Neonates, Receiving Total Parenteral Nutrition (TPN)
- What is being tested?
- Total parenteral nutrition (TPN). This is total nutrition provided by central vein.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 2 Apr 2023to 2 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Glenda Courtney-Martin
Toronto, Ontario, M5G 1X8
Glenda Courtney-Martin, 4168135744, glenda.courtney-martin@sickkids.ca
About this study
Official title: Phenylalanine, Methionine and Histidine Requirements in Total Parenteral Nutrition (TPN) Fed Neonates
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.
Read the detailed description
The study is based on the carbon oxidation protocol. Each baby will receive one or two levels of either phenylalanine or methionine or histidine. 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 Phenylalanine/ Methionine/ Histidine 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 regular blood work done for clinical monitoring.
- Being tested
- Total parenteral nutrition (TPN). This is total nutrition provided by central vein.
- Keywords
- Neonates, Total parenteral nutrition (TPN), Phenylalanine, Methionine, Histidine
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total parenteral nutrition (TPN). This is total nutrition provided by central vein.Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Phenylalanine, methionine, histidine requirement | Experimental | Not described Receives: Drug: Total parenteral nutrition (TPN). This is total nutrition provided by central vein. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino acid oxidation using a labelled amino acid.
Breath samples will be collected and analyzed to determine the amount of amino acid oxidized. This will be used to determine the amount retained in the body and therefore the amount that is required for protein synthesis.
Measured: 48 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start2 Apr 2023
- Primary completion2 Sep 2026 (estimated)
- Study completion2 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable NeonatesStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenda Courtney-Martin, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562310
- Sponsor's protocol ID
- 1000076474
- Status last verified
- May 2025
- First submitted
- 22 Sep 2022
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phenylalanine, Methionine and Histidine Requirements in Total Parenteral Nutrition (TPN) Fed Neonates
- ClinicalTrials.gov ID
- NCT05562310
- Acronym / sponsor ID
- 1000076474
- Keywords
- Neonates, Total parenteral nutrition (TPN), Phenylalanine, Methionine, Histidine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 2 Sep 2026 (estimated)
- Study completion
- 2 Sep 2027 (estimated)
- First posted
- 30 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is based on the carbon oxidation protocol. Each baby will receive one or two levels of either phenylalanine or methionine or histidine. 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 Phenylalanine/ Methionine/ Histidine 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 regular blood work done for clinical monitoring.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phenylalanine, methionine, histidine requirement | Experimental | Drug: Total parenteral nutrition (TPN). This is total nutrition provided by central vein. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Phenylalanine, methionine, histidine requirement |
Primary outcome
Amino acid oxidation using a labelled amino acid.
Time frame: 48 hrs
Breath samples will be collected and analyzed to determine the amount of amino acid oxidized. This will be used to determine the amount retained in the body and therefore the amount that is required for protein synthesis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total parenteral nutrition (TPN). This is total nutrition provided by central vein. in people with Stable Neonates and Receiving Total Parenteral Nutrition (TPN), run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Glenda Courtney-Martin (4168135744, glenda.courtney-martin@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amino acid oxidation using a labelled amino acid. (time frame: 48 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.