Assessing amino acid needs in neonates on total parenteral nutrition
Official title: Phenylalanine, Methionine and Histidine Requirements in Total Parenteral Nutrition (TPN) Fed Neonates
Run by The Hospital for Sick Children · NCT05562310 · Data updated 2026-11-12
This study is trying to find out how much of three important amino acids babies on total parenteral nutrition need to stay healthy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 28 Days |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | April 2, 2023 |
| Main results expected | September 2, 2026 |
| Study ends | September 2, 2027 |
| Registry record updated | May 30, 2025 |
| Trial ID | NCT05562310 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are stable preterm babies who are fully TPN fed and medically stable.
✕Probably not a fit
Patients who are on mechanical ventilation or have unstable medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project evaluates the requirements for three essential amino acids—phenylalanine, methionine, and histidine—in stable neonates receiving total parenteral nutrition (TPN). The study employs the Carbon Oxidation method to determine the specific needs for each amino acid by analyzing breath and urine samples from the participants. Each baby will undergo a two-day assessment with varying levels of the amino acids to establish their requirements. The results will help refine nutritional guidelines for TPN in neonates.
Why it matters
Potential benefit: If successful, this study could lead to more tailored nutritional formulations for neonates, improving their growth and health outcomes.
How similar studies have gone: While this approach is based on established methods, the specific focus on these amino acids in TPN-fed neonates is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Glenda Courtney-Martin
Toronto, Ontario, Canada Recruiting
Study contacts
- Study coordinator: Glenda Courtney-Martin
- Email: glenda.courtney-martin@sickkids.ca
- Phone: 4168135744
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Isoleucine, leucine, valine and tryptophan needs in newborns on TPN
This project will test how much isoleucine, leucine, valine, and tryptophan newborns who are fully fed by TPN need to support growth and normal metabolism.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.