Isoleucine, leucine, valine and tryptophan needs in newborns on TPN
Official title: Isoleucine, Leucine, Valine and Tryptophan Requirements in Total Parenteral Nutrition (TPN) Fed Neonates
Run by The Hospital for Sick Children · NCT06372314 · Data updated 2026-11-12
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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 1 Day to 28 Days |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | The Hospital for Sick Children Academic / other |
| Locations | 1 site (Santa Maria) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | April 2, 2026 |
| Trial ID | NCT06372314 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are medically stable neonates born at or after 28 weeks gestation, aged 28 days or less, who are receiving at least 90% of calories and protein via TPN and have normal lab results without infection or fever.
✕Probably not a fit
Babies who are mechanically ventilated or on significant respiratory support, small for gestational age, actively infected, receiving more than 10% of protein enterally, or on medications that alter amino acid metabolism are unlikely to be eligible or to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-center project in two hospitals in Brazil uses the carbon oxidation (indicator amino acid oxidation) method to define requirements for four essential amino acids in neonates receiving nearly all nutrition by TPN. Each enrolled baby will receive one or two intake levels of a target amino acid over two-day periods, with L-[1-13C]phenylalanine added as the indicator and L-[1-13C]Na bicarbonate used to measure CO2 production. Investigators will collect breath, urine, and small blood samples and analyze the indicator amino acid response using a biphasic linear mixed-effect model to identify the breakpoint or mean requirement for each amino acid. The team plans about 18–20 infants per amino acid and hypothesizes requirements may be substantially lower than current commercial formulations.
Why it matters
Potential benefit: If successful, the results could enable more precisely dosed neonatal TPN amino acid formulations that reduce excess intake and improve metabolic safety.
How similar studies have gone: The indicator amino acid oxidation technique is a validated method for defining amino acid needs in older populations and has been applied in infants before, but using it to set TPN-specific requirements for these four amino acids in fully 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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Hospital de Caridade Dr. Astrogildo de Azevedo, and University Hospital of Santa Maria, Santa Maria, Brazil
Santa Maria, Brazil Recruiting
Study contacts
- Study coordinator: Glenda Courtney-Martin, PhD
- Email: glenda.courtney-martin@sickkids.ca
- Phone: 416 813 5744
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Assessing amino acid needs in neonates on total parenteral nutrition
This study is trying to find out how much of three important amino acids babies on total parenteral nutrition need to stay healthy.
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.